A combination of therapies (MAD and CPAP) allows greater flexibility of treatment and opportunity for ongoing adherence in circumstances where CPAP cannot be used
Barnes, 2004, RCT, Australia
104 patients
47.0 ± 0.9
MAD, CPAP, and placebo
21.3 ± 1.3 AHI
PSG, neurobehavioral testing, 24-hr ambulatory blood pressure, and echocardiography, maintenance of wakefulness test, Stanford Sleepiness Scale, ESS
11 months
77% of subjects achieved at least 70% of the maximum possible protrusion. With this degree of protrusion, 56.1% subjects achieved a reduction in the AHI of at least five events per hour
Benoist, 2017, RCT, Netherlands
99 patients: 51 MAD, 48 SPT
49.2 ± 10.2
MAD and SPT
11.7 (9.0–16.2) AHI
PSG, ESS, FOSQ
3 months
The SPT and MAD were equally effective in reducing the AHI and ODI in POSA patients
For patients using SPT, the AHI will likely decrease in all sleeping positions when MAD is added
Berg, 2020, RCT, Norway
104 patients: 55 CPAP, 49 MAD
49.6 (9.0)
MAD and CPAP
16.3 (12.4–23.0) AHI
SF36, PSQI, PSG
12 months
Seven (14.3%) in the MAD treatment group had quit treatment, all reporting not being compliant to treatment
Bishop, 2014, RCT, USA
24 patients
47.4 ± 2.6
Klearway and TAP3
19.3 ± 4.6 AHI
ESS, SAQLI, RSR
3 months
Age negatively influences a patient’s ability or willingness to adapt to an intraoral appliance
Neither appliance proved to be more effective than the other in any AHI classification for any variable recorded
Blanco, 2005, RCT, Spain
24 patients: 12 advanced, 12 control
55.6 ± 11.8 advanced, 53.0 ± 12.7 control
Two models of MAD with 5 mm were applied, one model with an advance of 75% and one without
33.8 (14.7) AHI advanced, 24.0 (12.2) AHI control
PSG, ESS, SF-36, FOSQ
3 months
Patients in the advanced group presented a decrease in the number of apneas in the supine position, suggesting that the device could be particularly effective in cases of position-dependent OSA
The group treated with the MAD, which advances the mandible, presented a greater reduction, and more than half of the patients in this group achieved complete control of OSA symptoms
Bloch, 2000, RCT, Switzerland
24 patients
50.6 ± 1.5
Monoblock, Herbst
26.7 ± 3.3 AHI
ESS, PSG
5 months
The AHI during treatment with the OSA-Herbst device but not with the OSA-Monobloc device was significantly correlated with the baseline AHI
Both IOAs improved sleep-disordered breathing and measured snoring. These effects were even more pronounced for the OSA-Monobloc than for the OSA-Herbst device, but the differences were not significant
Seven patients complained of temporomandibular joint pain, four of muscle discomfort, and three of dental discomfort. The prevalences of these side effects were identical for the OSA-Herbst and OSA-Monobloc appliances
Brown, 2021, CT, Australia
105 patients
45 ± 12
MAD
30 ± 19 AHI
PSG, MRI
3 months
Participants without PMR tendon had greater mandibular advancement, greater anteroposterior airway diameter increase, and increased odds of complete response in those who tolerated treatment
About 7% of participants overall were unable to acclimatize to MAS because of ongoing pain, jaw locking, or other and withdrew, the majority of these being PMR tendon absent
There were no significant differences in BMI, neck circumference, and baseline AHI between the “success” subjects with a complete response to treatment and the poor responders in the treatment failure category
Neither titration method (self-titration or fixed at 70% protrusion) was significantly superior
Chan, 2010, CT, Australia
69 patients
50.5 ± 10.1
MAD
27.0 ± 14.7 AHI
PSG, MRI
8 weeks
There were no significant differences between responders and nonresponders with respect to age, gender, or BMI
There were no significant differences between responders and nonresponders with respect to age, sex, body mass index, or baseline AHI. An increase in the velopharyngeal cross-sectional area with mandibular advancement was significantly associated with a treatment response on polysomnography
Chen, 2008, CT, China
70 patients
50.0 ± 9.6
MAD
0.0–68.0 RDI
Dental model analysis system
7 years 4 months
The study provides evidence of significant occlusal changes, but none of the 70 patients stopped OA treatment because of this
Body mass index (BMI) was significantly smaller at baseline in the responders than in the nonresponders. Neck circumference (NC) of the OSA patients was also significantly smaller at baseline in the responders than in the nonresponders
Dal-Fabbro, 2014, RCT, Brazil
39 patients
47.0 ± 8.9
Placebo, MAD, CPAP.
42.3 ± 4.5 AHI
PSG, ESS
6 months
Supine and nonsupine AH events both improved with CPAP and MAD, with the first one which had a stronger effect
De Almeida, 2002, CT, Brazil
7 patients
47.4
MAD
13.20 AHI
PSG, MRI
9 months
One patient had an anterior displacement with reduction, and two patients had anterior displacement without reduction. In the other two patients, osteophytes were seen in both joints
De Britto-Teixeira, 2013, RCT, Brazil
19 patients
48.6 (9.6)
Placebo and Twin Block
16.3 ± 7.2 AHI
PSG
10 months
The use of TB produced a reduction in AHI from 16.3 (SD = 7.2) to 11.7 (SD = 9.4). The use of WRAP (placebo) yielded an increase in AHI from 16.3 (SD = 7.2) to 19.6 (SD = 14.8)
De Corso, 2015, CT, Italia
65 patients
44.26
MAD
21.4 ± 6 AHI
DISE, ESS, Berlin
3 months
The presence of an anteroposterior pattern of closure and absence of the latero-lateral one at the level of the palate, as documented during pretreatment DISE, are associated with therapeutic success in mild/moderate OSA patients treated with custom-made MADs
De Ruiter, 2018, RCT, Netherlands
99 patients
49.2 ± 10.2
MAD and SPT
11.7 (9.0–16.2) AHI
PSG, position sensor, FOSQ-30, ESS
12 months
Supine AHI decreased to a similar extent in the two groups
The most common adverse events in both groups were persistent snoring and persistent tiredness. Tooth pain, temporomandibular dysfunction, and open bite
Deane, 2009, RCT, Australia
27 patients
49.4 ± 11.0
MAD and TSD
27.0 ± 17.2 AHI
PSG, questionnaries, ESS
12 weeks
Analysis of the effect of the appliances on AHI in supine and other body positions during sleep demonstrated that AHI between baseline and MAD was significantly different
Dieltjens, 2015, RCT, Belgium
20 patients
52.5 ± 10.5
MAD and SPT
24.6 ± 10.2 AHI
PSG, questionnaires
6 months
MAD therapy was effective in reducing both supine AHI and non-supine AHI when compared to baseline
A combination of SPT + MAD therapy further reduces the sleep apnea severity when compared to the individual treatment modalities
Doff, 2010, RCT, Netherlands
103 patients: 51 MAD, 52 CPAP.
49 ± 10
MAD and CPAP
39 ± 31 AHI
PSG, lateral cephalogram
2 years
Mainly dental changes in the craniofacial morphology in the MAD group compared with the CPAP group following 2 years of treatment
Doff, 2012, CT, Netherlands
103 patients: 51 MAD, 52 CPAP.
49 ± 10
MAD and CPAP
39 ± 31 AHI
PSG, dental models in articulator
2 years
A decrease in overjet, overbite, number of occlusal contact points, and a different anterior–posterior relationship are dental changes most likely to occur
Doff, 2012, CT, Netherlands
103 patients: 51 MAD, 52 CPAP.
49 ± 10
MAD and CPAP
39 ± 31 AHI
Mandibular function and impairment questionnaire (MFIQ), function impairment rating scale (FIRS), questionary, PSG
2 years
The occurrence of (pain-related) TMDs increases in the initial period of MAD therapy but tends to return to baseline values during a 2-year follow-up
Doff, 2013, RCT, Netherlands
103 patients: 51 MAD, 52 CPAP
49 ± 10
MAD and CPAP
39 ± 31 AHI
PSG, ESS, FOSQ, SF-36
2 years
Older, obese, and with predominantly severe OSAS patients switched from MAD therapy to CPAP therapy
Tooth pain, temporomandibular joint pain, myofascial pain, dry mouth, and excessive salivation. Long-term oral appliance therapy and CPAP may result in dental changes in patients with OSAS
Edwards, 2016, RCT, USA
14 patients
51.8 ± 2.3
MAD
29.6 ± 5.3 AHI
Two PSG (clinical and research), with and without OA
1 week
Baseline anatomy/collapsibility (i.e., Vpassive) and loop gain were independent predictors of patients likely to gain the greatest benefit from MAD therapy. Trend for responders to have more severe OSA without their devi
El-Sohl, 2011, CT, USA
10 patients
56.9 ± 6.1
Auto-CPAP, MAD
23.5 ± 13.4 AHI
PSG, ESS
3 days
The combination therapy was successful in reducing optimal CPAP pressure and normalizing AHI in selected patients with OSA
Two patients noted a feeling of pressure in the face, and one patient complained of early morning, non-persisting discomfort in the mouth and temporomandibular joint
Engleman, 2002, RCT, United Kingdom
51 patients
46 ± 9
MAD and CPAP
31 ± 26 AHI
Questionnaires, home sleep monitoring
4 months
CPAP preference with higher body mass index
Fleury, 2004, CT, France
40 patients.
57 ± 9
MAD
46 ± 21 AHI
PSG, questionnaires, ESS, VAS
18 months
At the first assessment, which was performed at 80% of MMA, only four patients presented sufficient clinical and oximetric improvement to allow polysomnography. These four patients were in the success group. For the remaining 36 patients, advancement was continued beyond the initial advancement. 25% of advancements were motivated by abnormal ODI, despite the resolution of the symptoms
For all of the patients in groups (dental class of Angle) 2 and 3, mandibular advancement had to be stopped due to temporomandibular discomfort
Fransson 2002, CT, Sweden
65 patients
54.8 ± 9.0
MAD
14.0 ODI
Cephalogram, PSG
2 years
The SNB angle decreased significantly, because of posterior rotation of the mandible and a significant increase in anterior face height. We found lower incisors to be proclined after 2 year
Fransson, 2022, RCT, Sweden
314 patients
55 (49;65) non-POSA and 54 (47;63) POSA
Monobloc and bibloc
29 (17;39) AHI non-POSA, 23 (14;30) AHI POSA
Night at-home polygraphic study, ESS, PGIC
1 year
The subgroup of subjects with severe OSA at baseline showed the greatest improvements in AHI. The decrease in supine AHI was significantly greater among subjects with POSA, whereas the decrease in nonsupine AHI was significantly greater in the non-POSA group
The original efficacy studies showed equivalent efficacy of the 2 types of appliances, so they were analyzed together in this study. Advance the mandible to 75% of maximal capacity or by at least 5 mm
Friedman, 2010, CT, USA
87 patients
45.70 ± 11.47
Two nontitratable one-piece MAD and a titratable two-piece device
39.96 ± 23.70 AHI
ESS, PSG, VAS
2 months
Patients in the study with prior surgery did not fare better than those naïve to surgery
Garcia-Campos, 2016, CT, Mexico
30 patients
49.7 ± 12.45
MAD
22.45 ± 6.14/hr AHI
ESS, questionnaires, PSG
3 months
The most commonly found side effect was excessive drooling, which lasted for about a month and then disappeared with no treatment. The second most frequent side effect was dental pain, which was also self-limited. Four patients reported no side effects
Gauthier, 2009, RCT, Canada
23 patients
47.9 ± 1.6
Two MADs
9.4 ± 1.1 RDI
PSG, FSS, ESS, FOSQ, questionnaires
2 years
The RDI was also reduced by both MAA with no difference between appliances in the supine position or in non-REM sleep
Both appliances had 4 mm advancement, but the silencer was statistically more efficient at reducing the RDI
Geoghegan, 2015, RCT, China
45 patients
52
Bibloc and monobloc MADs
21.1 (14.2–50.1) AHI
Lateral cephalogram, PSG, ESS
26 weeks
Both MADs resulted in similar significant cephalometric changes around the hyoid bone position and soft palate length
After treatment, there was a highly significant reduction in AHI with the monoblock and with the twin block. The monoblock demonstrated a significantly better result than the twin block
Changes were seen in several other measurements (SNB, mandibular plane angle, overjet, overbite, and face height) with both MADs
Ghazal, 2009, RCT, Germany
103 patients: 51 IST, 52 TAP
55.5 ± 10.6
Two MADs
32 ± 6 AHI IST, 37 ± 8 AHI TAP
PSG, ESS, PSQI, questionnaires
2 years
51% of the patients with the IST and 79.2% with the TAP demonstrated complete treatment success
Gogou, 2022, CT, Greece
50 patients: 34 DISE, 16 control
48.8 ± 12,3
MAD
31.7 ± 17.3 AHI
DISE, PSG, questionnaires
8 weeks
An increase of upper-airway dimensions during mandibular advancement during DISE may have predictive value regarding the likelihood of successful treatment with a MAD
By using DISE, the full short-term efficacy of MAD treatment was achieved with less initial mandibular protrusion than in the control group
Gotsopoulos, 2002, RCT, Australia
73 patients
48 ± 11
MAD, control device
27.1 ± 15.3 RDI
ESS, questionnaire, PSG
10 weeks
The MAD produced a 52% reduction in mean RDI and a significantly higher mean minimum arterial oxygen saturation (MinSao2) compared with the control device
A significantly higher proportion of patients experienced side effects with the MAD than with the control device, namely, jaw discomfort, tooth tenderness, and excessive salivation
After 3 and 12 months of follow-up, MAD and SPT have comparable effects on improvements in the AHI and compliance in subjects with mild-to-moderate POSA
Treatment with both SPT plus MAD can combine the advantages of the two methods and achieve complementary results
Isacsson 2019, RCT, Sweden
302 patients: 146 bibloc, 156 monobloc
54 (12.2) bibloc, 55 (11.4) monobloc
Bibloc and monobloc MADs
27 (14.2) AHI bibloc, 25 (14.1) AHI monobloc
PSG, ESS, FOSQ
2 months
The effect of reducing AHI was significantly equivalent between the two appliances
Ishiyama, 2017, RCT, Japan
25 patients. 13 jaw exercises, 12 placebo
51.4 ± 9.7
MAD
21.5 ± 10.0 AHI
PSG, questionnaires, ESS, PSQI, VAS
3 months
Arthralgia at the 1-month evaluation. Disc displacement developed in one subject in the JE-group at the 2-week and 1-month evaluations and in two or three subjects in the PE-group across evaluation periods. Chewing pain and jaw-opening pain in the morning at the 1-month evaluation
Jo, 2018, CT, Korea
79 patients
44.7 ± 13.1
MAD
17.3 ± 5.6 AHI
Questionnaires, DISE
2 years
This study revealed that the degree of obstruction at the levels of the velum and epiglottis were significantly decreased after long-term oral appliance therapy
Johal, 2007, CT, UK
50 patients
51.1 (7.1)
MAD
17.3 (5–30) AHI
ESS, PSG, EMG
8 weeks
A highly significant increase in the EMG activity was observed in two upper airway dilatory muscles and a muscle of mastication, following the placement of MAS in awake OSA patients
Johal, 2017, RCT, United Kingdom
25 patients
44.9 (SD 11.5)
Ready-made and custom-made MADs
13.3 (10.9–25) AHI
Visi-Lab Greyflash at home, ESS, FOSQ, SF-36, OAOQ
7 months
The MRDc resulted in a statistically significant difference in terms of total treatment success (96%; n = 24). The MRDr resulted in a total treatment success of 64% (n = 16)
Johnston, 2002, RCT, Northern Ireland
21 patients
55.10 ± 6.87
MAD, placebo
31.93 ± 21.18 AHI MAD; 30.69 ± 18.82 AHI placebo
ESS, questionnaires, Edentrace II
12 weeks
MAD was significantly more effective than the placebo in improving the outcome measures
The most commonly reported complication was excessive salivation when wearing the appliance. Some subjects reported temporary occlusal changes in the morning. Temporary TMJ discomfort on waking was common
Kato, 2000, RCT, Japan
37 patients
49.0 (27.1–66.6)
Three MADs with 2-, 4-, and 6-mm mandibular advancements
26.0 (11.2 to 72.0) ODI
Endoscopy, oximetry
1 week
Obese patients with severe nocturnal desaturation may not be appropriate candidates for MAD therapy. The presence of severe OP and hypopharyngeal narrowing may be an alternative explanation for the poor responses to the MADs
Step-advancement of mandibular position resulted in a dose-dependent reduction of closing pressure of the passive pharynx, (2) successful improvement of nocturnal oxygenation appeared to be achieved when the MAD reduced the closing pressure of the passive pharynx below atmospheric pressure, and (3) each 2-mm mandibular advancement coincided with approximate 20% improvement of the number and severity of nocturnal desaturations
Excessive salivation and transient discomfort or pain of the temporomandibular joint for a brief time after awakening were commonly reported
Kazemeini, 2022, RCT, Belgium
10 patients
48.0; 41.5; 55.6
MAD with subjective, objective PSG titration and DISE titration
21.3; 17.5; 26.8 AHI
PSG, DISE
4 months
Comparable amounts of titration and corresponding efficacy in terms of AHI reduction and reduction in subjective symptoms were found among the three titration methods. In titrationSubj, the relief of subjective complaints may lead to premature interruption of the titration and a suboptimal treatment outcome. On the other hand, objective titration may induce discomfort at the start of MAD treatment, therefore possibly making habituation more difficult
La Mantia, 2018, RCT, Italy
40 patients
49.6 ± 11.6 AB, 47.5 ± 10.2 BA
Bibloc and monobloc MADs
28.5 ± 5.7 AHI
PSG, ESS, SAQLI
22 weeks
Use of the monoblock MAD should be considered when patients with OSAS choose MAD treatment, as it was more efficient in improving objective OSAS parameters compared to twinblock MAD
Lai, 2019, CT, Australia
22 patients
49 ± 12
MAD and EPAP
15 (10,34) AHI
PSG
6 weeks
The addition of oral and oral plus nasal EPAP valves to a novel MAS device resulted in stepwise reductions in OSA severity
Lai, 2022, CT, China
105 patients: 65 with retrognathia (33 CPAP, 32 MAD), 40 no (20 CPAP, 20 MAD)
46.72 + 10.19 with, 46.78 + 11.37 without
MAD and CPAP
37–38 mean AHI
PSG, cephalometry, questionnaires
12 months
Mandibular advancement device treatment of severe OSA patients with mandibular retrognathia is superior to that of severe OSA without mandibular retrognathia in terms of AHI and ODI
Lawton, 2005, RCT, UK
16 patients
44.8 (range 24.0–68.4)
Twin block, Herbst
45.5 (29.0–68.0) AHI
Questionnaires, domiciliar sleep study, ESS, SF-36, VAS
14 weeks
There was no significant difference in the median AHI scores produced by treatment with the Herbst (24.5, n = 16) and TB (34.0, n = 15) appliances
With Herbs appliance, muscular discomfort was experienced by 56% initially, but this improved to 25% after 4 6 weeks. With the TB, there was a reduction from 50% to 19%. Initial TMJ discomfort improved from 69% to 31% and 38%–19%, respectively, for the Herbst and TB appliances. An abnormal bite was experienced initially by 69% of Herbst and 38% of TB, and they reduced to 56 and 21. Dry mouth from 63 to 56 with Herbst and 75–63 with TB. Excessive salivation 31–19 for Herbst and 44–31 for TB
Ma, 2020, CT, China
42 patients
41.5 ± 9.0
MAD
23.4 ± 11.5 AHI
Rhinospirometry, rhinomanometry, magnetic resonance imaging, home sleep testing, and PSG baseline
1 year
It was found that the dose-dependent relationship between AHI reduction and mandibular protrusion was nonlinear, and the overall success and normalization rate entered a relative plateau stage after approximately 70% MMP
Makihara, 2022, RCT, Japan
32 patients: 17 50%, 15 75%
62.2 ± 1.90
MAD 50% and 75% of maximum mandibular protrusion
22.3 ± 13.49 AHI
ESS, PSG
4 months
Effective treatment across both mandibular advancement groups was more often documented in females compared to males
While treatment success rates were higher with 50% mandibular advancement compared to 75% mandibular advancement, this difference was not statistically significant in patients with mild to moderate OSA
Marco-Pitarch, 2018, CT, Spain
41 patients
54.5 ± 10.3
MAD
22.5 ± 16.8 AHI
ESS, PSG, VAS
6 months
The higher the SaO2 Min. initial value, the smaller the improvement produced by MAD, and the larger the arousal index initial value, the larger the improvement after placement of the oral appliance. Only gender and Fujita index were statistically significant
Marklund, 1998, CT, Sweden
26 patients: 12 Posa, 14 non-POSA
59 POSA, 54 non-POSA
MAD
41 (range, 16–70) AHI
PSG
2 months
This study demonstrates that supine-dependent sleep apnea is a strong predictor of successful treatment with the MAD in patients with obstructive sleep apnea
Marklund, 2004, CT, Sweden
619 patients: 160 snoring, 459 OSA
51 men (range, 25–74). 55 women (range, 30–75)
MAD
16 (range, 0.0–76) AHI
PSG
2 years
Women with sleep apnea were more likely than men with sleep apnea to have treatment success with the mandibular advancement device. Supine-dependent sleep apneas, mild disease, and an increase in mandibular advancement predicted treatment success among the men, while mild sleep apnea was associated with treatment success in the women
Discomfort, including excessive salivation or a feeling of awkwardness when wearing the device, was the main cause of the poor tolerability of the device. Insufficient effects on snoring or odontologic problems, i.e., symptoms from the craniomandibular system, periodontal disease, or changes in occlusion during treatment, were other explanations for a failure to accept the device
Marklund, 2015, RCT, Sweden
91 patients: 45 MAD, 46 placebo
49.8 (10.6) MAD, 54.1 (9.4) Placebo
MAD
15.6 (9.8) AHI MAD, 15.3 (10.5) AHI placebo
ESS, KSS, OSLER, SF-36, FOSQ, PSG
4 months
It was observed that patients using a MAD slept more in the supine position than in nonsupine positions, indicating that the effect of an oral appliance in reducing sleep apneas was even more effective than the results of the AHI revealed
The AHI was 6.7 (SD, 4.9) for the MAD group, which was significantly lower than in patients using the placebo device (16.7 (SD, 10.0)); Snoring appeared less than once a week during treatment with the oral appliance, which was less than with the placebo device
Jaw pain, tooth pain, hypersalivation, and bite changes. Adverse effects were more common with MAD than with the placebo device
Marklund, 2016, RCT, Sweden
9 patients
68.1 (60.0–76.3)
MAD
17.3 (IQR 9.7–26.5) AHI
PSG, ESS
16.5 years
Both the overjet and the overbite decreased significantly during treatment with OA. Deteriorations in OSA severity and a loss of OA efficacy were found in the present small sample of patients treated continuously for more than 15 years with this method
AHI with the MAD is positively correlated with neck circumference and baseline AHI and negatively correlated with the width of the retropalatal airway and angulation of the mandibular plane to the anterior cranial base
Mosca, 2022, CT, Canada
58 patients
51.6 ± 8.0 (28–70)
MAD
31.4 ± 23.0 (10.0–105.3) AHI
Home sleep test, AI, and heuristic prediction method
3 nights/6 months
Irritation to teeth, jaw, or gums; dryness; excessive salivation; and sleep disturbance as a result of OAT. The percentage of participants who reported experiencing bite changes as a result of OAT was 27.3
Mostafiz, 2011, CT, Australia
53 patients
49.5 ± 11.8
MAD
33.014.4 AHI
Lateral cephalogram
2 months
Treatment nonresponders were significantly older with more severe OSA than complete responders. Maxillary length and upper-facial height were significantly shorter in complete responders than in partial responders. BMI, tongue area, oral area, and tongue/oral CSA ratio were considered as independent variables for predicting %AHI using multiple linear regression
Neill, 2002, RCT, New Zeeland
19 patients
47.7 ± 10.1
Two MADs
22.2 ± 19.8 (SD) RDI
PSG, questionnaires
6 weeks
The mean mandibular protrusion in eleven subjects was 61.5% of the maximum, which was lower than ideal and may have reduced the success of this treatment. However, we found no relationship between the degree of advancement and measures of OSAS improvement
Ng, 2006, CT, Australia
12 patients
51 ± 9
MAD
22.0 ± 2.6 AHI
PSG, nose mask, nasendoscopy
8 weeks
Patients with oropharyngeal closure were significantly more likely to have complete responses with MAD therapy than were patients with velopharyngeal closure. The AHI supine reduced
Low frequency of clinical signs of TMD pain in mild to severe OSA patients
Clinical signs of temporomandibular disorders who also expressed a desire for treatment of their TMD complaints, an unhealthy periodontium (periodontal pockets >5 mm), dental pain, and/or inadequate retention possibilities for an intraoral appliance were excluded as well
Niżankowska-Jędrzejczy, 2014, CT, Poland
38 patients: 22 OSAS MAD, 16 control
52.50 ± 8.33 OSA, 54.06 ± 12.09 control
MAD
24.00 (15.70–31.25) AHI
PSG, blood samples
6 months
Supine AHI significantly decreased from 36.50 to 15 and 12 at 3 and 6-month follow-up
Op De Beeck, 2019, CT, Belgium
100 patients
47.6 ± 10.0
MAD
21.0 ± 11.2 AHI
PSG, DISE
3 months
The presence of tongue base collapse during baseline DISE examination is strongly correlated to favorable MAD response in patients with OSA. Patients with complete concentric collapse at the level of the palate (CCCp) and/or complete laterolateral oropharyngeal collapse (CLLCop) during DISE tend to deteriorate under MAD treatment
Mild, temporary side effects, as is usual during the startup of any MAD treatment
Op De Beeck, 2021, CT, Belgium
36 patients
48.5 (45.8–51.1)
MAD
23.5 (19.7–29.8) AHI
PSG, ESS, VAS
3 months
MAD responders were slightly younger than nonresponders. MAD treatment significantly improved AHI, supine AHI, and nonsupine AHI. A greater reduction in AHI was associated with lower loop gain, a higher arousal threshold, a lower response to arousal, moderate collapsibility, and weaker muscle compensation
Pepin, 2019, RCT, France
198 patients: 100 TALI, 98 ONIRIS
51 (SD, 12)
Heat-molded and custom-made MADs
26.6 SD 10.4 AHI
ESS, VAS, SF-12, PSG
2 months
After 2 months, both treatments significantly improved AHI per hour, and scores for SF-12 (both the physical and mental subscores), Pichot fatigue and depression scales, Epworth sleepiness scale, and snoring with no significant differences between the two MADs
The most frequently reported side effects were dental pain, temporomandibular joint pain, discomfort related to MAD volume in the mouth, muscular pain, and muscle aches. Excessive salivation and gag reflex were observed in the ONIRIS group
Perck, 2020, CT, Belgium
100 patients
47.6 ± 10.0
MAD
14.6 (9.3–24.0) AHI
Nasopharyngoscopy, PSG
3 months
The current study indicated a relationship between a prominent uvula (C-shaped palate) and a negative response to MAD treatment
MAD had a significant effect on AHI, calculated separately for the supine and nonsupine sleeping positions
AHI, Epworth score, and vitality in the MAD group differed significantly from that in the MNA group and no-intervention group
Two patients could not tolerate the appliance; one patient suffered loosening of the teeth, and one suffered pain of the temporomandibular joint
Petri, 2019, CT, Denmark
62 patients
51 (range 27–65)
Custom-made, monobloc MAD
34 (range 6–117) AHI
PSG, cephalometry, acoustic reflectometry
13 weeks
POSA is indicative for success, and nonsupine AHI is inversely related to success. Cephalometry was not predictive
Pitsis, 2002, RCT, Australia
23 patients
50 ± 10 (29–64)
MAD-1 and MAD-2 with 4 and 14 interincisal opening
21 ± 12 (6–47) AHI
Questionnaires, PSG, ESS
2 months
The amount of vertical opening induced by the appliance does not have an impact on treatment efficacy to any great extent
Excessive salivation (48% versus 57%), dry mouth (26% versus 22%), tooth grinding (22% versus 13%), and gum irritation (22% versus 13%) between MAD-1 and MAD-2, there was a trend toward a greater proportion of patients reporting jaw discomfort with MAS-2 (48% versus 70%)
Quinnell, 2014, RCT, UK
90 patients
50.9 (11.6)
Thermoplastic ‘boil and bite’ device, semi-bespoke device, and bespoke MAD
13.8 (6.2) AHI
PSG, ESS, FOSQ, SAQLI, SF-36, (EQ-5D-3 L)
5 months
The response was significantly associated with baseline BMI and contemporaneous BMI. Baseline AHI, ESS, gender, age, and compliance were not associated with treatment response
Mouth problems/discomfort and excess salivation with SP2 performing best for both
Randerath, 2002, RCT, Germany
20 patients
56.5 ± 10.2
CPAP, ISAD
17.5 ± 7.7 AHI
PSG
3 months
The patients in whom effectiveness was demonstrated in the first ISAD application differed from nonresponders by their significantly younger age and heavier weight
Two patients noted a feeling of pressure in the mouth; eight patients complained of early morning, nonpersisting discomfort in the mouth and temporomandibular joint
Remmers, 2017, CT, Canada
202 patients
48.4 (26–70) part 2, 49.8 (24–76) part 1
MAD
25.5 (10.5–65.1) ODI part 1, 31.1 (10.3–74.6) ODI part 2
In-home feedback mandibular positioner. Home PSG
Four nights
Some participants reported having tooth and/or gum discomfort during the FCMP test
Ringqvist, 2003, RCT, Sweden
67 patients: 30 MAD, 37 UPPP.
48.9 (46.3–51.4) years MAD, 51.0 (49.1–52.9) years UPPP
MAD, UPPP
17.9 (2.9) AHI dental, 19.9 (3.0) AHI UPPP
Lateral cephalometry
4 years
The vertical positions of the maxillary incisors (the distances incision superius (IS)-NSL and is-ML) and the mandibular incisors (the distance incision inferius (II)- NSL) changed significantly. The mandible rotated posteriorly (the mandibular plane angle increased by 0.5°). As a consequence of the posterior rotation of the mandible, the distances II-NSL and IS-ML increased
Rose, 2002, RCT, Germany
26 patients
56.8 ± 5.2
Two MADs
16.0 ± 4.4 RDI
PSG, VAS, portable somnograph
20 weeks
Both appliances investigated are effective in treating patients with mild OSA and can be used as an alternative treatment option. Concerning the RDI and AI, the nonretentive activator proved to be statistically more effective than the retentive Silencor® appliance
The initial side effects of the Silencor were higher salivation and complaints of pain in the gingiva and teeth. Side effects were more frequent with the activator; in addition to increased salivation, seven patients (30%) complained of pain in the TMJ and f tenderness in the masseter muscle
Klearway and MAD appliances are both effective in the treatment of mild and moderate OSA patients. An appliance (Klearway) that provides advancement of 85% of mandibular protrusion to open the upper airway was more effective in reducing the number of high apneic events during sleep than one (MAD), which provides 75%. Mandibular advancement device (MAD) should be preferred in mild OSA patients rather than moderate OSA patients
Mild pain in the TMJ and muscle tenderness. 25% of MAD had gum irritation (not in Kw, thanks to the thermoelastic material). 17% of KW had lower anterior tooth discomfort (due to increased retention) in the morning
Shi, 2023, RCT, Netherlands
31 patients: 16 MAD-H and 15 MAD-S
48.5 (±13.9)
MAD-H (Herbst appliance); MAD-S (SomnoDent)
16.6 (±6.7) /hr AHI
ESS, PSG, CBCT
3 months
The AHI, AHI-nonsupine (not the AHI supine), and ODI reduced significantly with MAD in situ in the total group
Although the freedom of vertical opening is different between MAD-H and MAD-S, it seems that the respiratory outcomes were not affected by this design feature
Sensitive teeth and painful jaw muscles were 3–4 times more frequent in the MAD-H group compared to the MAD-S group, which might be due to the different design features. Painful temporomandibular complaints. 19% of MAD-H and 13% of MAD-S had changes in occlusion in the morning
Suga, 2014, CT, Japan
20 patients: 7 rigid, 13 semi-rigid
58.1 ± 7.6 rigid, 57.9 ± 11.4 semi-rigid
Rigid and semi-rigid MAD
22.0 ± 13.8 AHI rigid, 20.5 ± 8.5AHI semi-rigid
PSG, TC
3 years
Neither the change of the occlusion nor TMDs occurred in the both groups
Sutherland, 2014, RCT, Australia
78 patients
49.3 ± 11.1
CPAP, MAD
30.0 ± 12.7/hr AHI
PSG
3 months
For MAD response by definition 1 (MAD AHI <5/hr), only baseline AHI and age were significant predictors. In predicting MAD response by definition 2 (MAD AHI <10/hr), the combination of baseline AHI, age, and CPAP pressure was significant. By definition 3 of MAD response (≥50% AHI reduction), only age and neck circumference, but not CPAP pressure, had predictive value
Excess upper airway soft tissue within the intramandibular space area, between gonion points and menton, is associated with a poor response to MAD treatment
Responders tended to have a longer lower face, increased facial axis angle, and reduced maxillary and mandibular position angles, suggestive of maxillary/mandibular retrusion. We did not find any sex differences in the relationship between treatment response and any of the clinical or phenotypic predictors
Sutherland, 2018, CT, Australia
80 patients
57.6 ± 11.2
MAD
26.4 ± 15.4 AHI
Nasopharyngoscopy, PSG
15 weeks
Our qualitative scoring system indicated a reduction in the level of collapse induced by the Müller maneuver with mandibular advancement. A stabilization of the airway with mandibular advancement would be expected
Svanholt, 2015, CT, Denmark
27 patients
52.6
MAD
10.6 and 111.7 (mean 39.1) AHI
Lateral cephalogram
4 weeks
BMI was significantly smaller in the success treatment group compared with the no-success treatment group. OSA patients with retrognathia of the jaws responded successfully to MAD treatment, and the retrognathia of the maxilla was found to be the most important factor for the MAD treatment outcome
Tan, 2002, RCT, UK
24 patients
50.9 ± 10.1
CPAP, MAD, MAD II
22.2 ± 9.6 AHI
PSG, questionnaires, ESS
2 months
Initial jaw discomfort early in the morning, but only one could not adapt to the device. There were no dental problems. Some degree of discomfort in the TMJ, facial musculature, or teeth on waking have been reported previously; these are normally mild and improve with time
Tegelberg, 2003, RCT, Sweden
74 patients: 38 : 50% MAD; 36 : 75% MAD
51.8 (49.0 ± 54.6) group 50–54.4 (52.4 ± 56.4) group 75
MAD
16.2 (2.9) AHI 50, 18.9 (4.7) group 75
PSG
1 year
Nine patients in group 50 withdrew before the 1-year follow-up for the following reasons: 3 could not tolerate the dental appliance. Ten patients in group 75 withdrew before the 1-year follow-up for the following reasons: 1 could not tolerate the dental appliance, and 2 had TMJ pain on movements of the mandible
Tegelberg, 2020, RCT, Sweden
302 patients: 146 bibloc, 156 monobloc
55 (11.4) bibloc, 55 (10.7) monobloc
Bibloc and monobloc MADs
25 (12.9) AHI bibloc, 23 (13.6) AHI monobloc
PSG
1 year
Although there was a greater reduction in the AHI in the bibloc group, the proportion of responders defined as having an AHI <10 at the 1-year follow-up was 68% in the bibloc group and 65% in the monobloc group
Treatment-related adverse events were generally mild and transient and occurred in 39% and 33% of bibloc and monoblock, respectively
Tong, 2020, RCT, Australia
16 patients
48 ± 11
MAD and CPAP
26 ± 13 AHI
PSG
12 weeks
Combination therapy with CPAP and a novel MAD can normalize pharyngeal pressure swings and lower CPAP requirements by 40% compared with CPAP alone
Umemoto, 2019, CT, Japan
52 patients: 23 twin-block, 29 fixed MAS
52.9 ± 10.7 twin-block, 53.8 ± 8.6 fixed
Bibloc and monobloc MADs
20.6 ± 11.5 AHI twin-block, 21.4 ± 15.2 AHI fixed
PSG, ESS, cephalogram radiographs
3 months
Significant improvements were observed in the AHI after using either the twin-block adjustable MAS allowing mouth opening or the fixed MAS, but the proportion of responders was significantly greater in the fixed group than in the twin-block group. In addition, the fixed group exhibited a significant improvement in the snoring index, arousal index, and desaturation rate
Patients with anodontia, severe malocclusion, severe periodontitis, or temporomandibular joint (TMJ) pain dysfunction syndrome were excluded
Uniken Venema, 2020, RCT, Netherlands
103 patients: 51 MAD, 52 CPAP.
61 ± 8 MAD, 59 ± 10 CPAP
MAD and CPAP
31.7 ± 20.6 AHI MAD, 49.2 ± 26.1 AHI CPAP
PSG, ESS, FOSQ, Short Form Health Survey (RAND-36), and a questionnaire evaluating adherence
10 years
The relapse in AHI could possibly be explained by a change in lifestyle, health status, or aging. With aging, there is an increase in pharyngeal closing pressure and upper airway resistance, due to a decrease in upper airway dilatator muscle strength
Tongue base collapse during baseline is a positive predictor for successful MAD treatment for OSA. Furthermore, the presence of CCCp is an adverse DISE phenotype towards MAD treatment outcome
It is solely the presence of a prominent uvula (C-shaped position of the soft palate) during tidal breathing that remains strongly correlated with MAD treatment deterioration after multimodal labeling
Vanderveken 2008, RCT, Belgium
35 patients
49 ± 9
Custom-made MAD, thermoplastic MAD
13 ± 11 AHI
PSG, VAS, ESS
9 months
A custom-made MAD is more efficacious than a prefabricated MAD made from thermoplastic material in the treatment of snoring and mild sleep apnea
No serious side effects were noted with either MAD
Vecchierini, 2019, CT, France
312 patients: 77 women, 235 man
57 women, 52 men
MAD
26.5 women, 30 men AHI
PSG, questionnaires
3–6 months
The treatment success rate was higher in women than in men, particularly in severe OSA. Complete response was also more common in women versus men across a range of AHI thresholds. Smaller neck circumference at baseline as a statistically significant independent predictor of MRD success in women. Treatment response in the severe OSA group was significantly better in women versus men. Decreases in AI and AHI were only independent predictors of treatment success and complete response in men
Women who experienced side effects were more likely to discontinue therapy than men. At least one side effect was reported by 55% of women and 49% of men. Mouth or temporomandibular joint pain was responsible for 60% of treatment discontinuations
Vroegop, 2013, CT, Belgium
200 patients
46 ± 9
Custom-made simulation bite. A custom-made, titratable, duobloc MAD
19 ± 13 AHI
PSG, DISE, ESS, VAS
3 months
The presence of palatal collapse at baseline evaluation was also associated with treatment response
Unable to tolerate the device throughout the night, choking sensations or side effects such as tooth tenderness and dry mouth, or a combination of thereof, and claustrophobia during MAD wear
The presence of hypopharyngeal collapse at baseline evaluation showed a tendency toward an association with a less favorable treatment outcome
Walker-Engstrom, 2002, RCT, Sweden
72 patients: 32 dental appliances, 40 UPPP
20–65
MAD
17.9 (2.9) AHI dental, 19.9 (3.0) AHI UPPP
PSG
4 years
One patient (3%) was not able to occlude his teeth in the same way as before treatment and reported TMJ pain on movement of the mandible. (1) Five patients (15%) reported unilateral TMJ sounds (four patients reported clicking, and one patient reported crepitation). Three of these patients had reported these symptoms before treatment
Walker-Engstrom, 2003, RCT, Sweden
77 patients: 40 MA 75% and 37 MA 50%
50.4 (47.7–53.1) MA 75%, 54.3 (52.2–56.4) for the 50% MA group
MAD 50% and 75%
47.0 (5.1) AHI MA 50%, 50.4 (4.7) AHI MA 75%
PSG, ESS, questionnaires
6 months
The patients who were normalized had a significantly lower mean value for BMI
The somnographic variables (AI, AHI, ODI, and SI) decreased significantly between baseline and the 6-month follow-up in both groups. No significant difference between the two groups
One patient (3%) in the 50% MA group was not able to occlude his teeth in the same way as before treatment. Five patients (12%) in the 75% MA group reported complaints of pain from the TMJ after an average time of 3 months (one resolved, four switched to MA 50%). Headache was significantly reduced after 6 months in the 75% MA group but not in the 50% MA group. In the 75% MA group, one patient could not tolerate the dental appliance. In the 50% MA group, five patients withdrew before the 6-month follow-up; two patients could not tolerate the dental appliance
Wang, 2015, CT, China
42 patients
47 ± 10
MAD
27 ± 19 AHI
Questionnaires, cephalometry, PSG
4 years
Skeletal changes, however, were predominantly induced by dental changes. Increases in lower and total anterior facial heights resulted from changes to the maxillary and mandibular incisors. Downward rotation of the mandible was caused by the retroclination of the maxillary incisors and the proclination of the mandibular incisors through incisal guidance, and lower and total anterior facial heights were thus increased
Wilhelmsson, 1999, RCT, Sweden
95 patients: 49 dental, 46 UPPP
49.3 (46.8–51.9) MAD, 51.0 (49.1–52.9) UPPP
MAD
18.2 (15.7–20.8) AHI MAD, 20.4 17.4–23.3 AHI UPPP
PSG, questionnaires, pharyngoscopy, home sleep
1 year
The positive effect of the dental appliance was also independent of whether the predominant obstruction determined by FPMM was in the oropharynx, the hypopharynx, or both
Pain and tenderness from the temporomandibular joint were recorded at the 1-year follow-up
Yanamoto, 2021, RCT, Japan
15 patients
50.0 (31.5–69.0)
Semi-fixed and fixed MAD
12.5 (8.9–17.0) AHI
PSG, a portable sleep test device
10 weeks
There was no significant treatment difference in AHI, 3% ODI, and lowest SaO2 between the semi-fixed and fixed MAD
The fixed MAD resulted in a significantly higher incidence of TMJ pain compared to the semi-fixed MAD
Yang, 2015, RCT, China
40 patients: 20 UPPP and 20 UPPP + MAD
46.7
MAD
55.53 ± 5.61 AHI
PSG, CT
3 years
The combination of UPPP surgery and MAD therapy can further improve upper airway ventilation on the basis of OSAHS surgery, remitting airway obstruction symptoms, significantly reducing the recurrence rate, and improving the patient quality of life
Zhou, 2012, RCT, China
16 patients
45.23 years from 26.3 to 55.4
Bibloc and monobloc MADs
26.38 ± 4.13 AHI
Questionnaires, PSG, cephalometric radiography
6 months
Both appliances manifested the potential to improve AHI, AI, and hypopnea index (HI), with a more statistically important improvement for AHI and AI in the case of the monoblock appliance
