Oral appliances for the management of severe snoring: a randomized controlled trial

The aim of this randomized controlled trial was to assess the effectiveness of a mandibular advancement appliance (MAA) in managing severe snoring. Twenty-eight adults with severe snoring and normal overnight oximetry were recruited from sleep disorder clinics. A maxillary placebo appliance and a MAA were worn by each subject for a period of 4-6 weeks each. Questionnaires at baseline and after each appliance period assessed bed partners' reports of snoring severity (loudness and number of nights per week), and patients' records of daytime sleepiness. Twenty-five subjects completed the entire trial. The MAA was significantly more effective than the placebo in reducing the frequency and loudness of snoring, the reported daytime sleepiness and the frequency of morning tiredness. Excessive salivation was the most commonly reported complication. It was concluded that the custom-made MAA was significantly more effective than the placebo in managing the main symptoms of severe snoring. However, not all subjects' partners reported an improvement with the MAA, with 84 per cent reporting a reduction in snoring loudness and 76 per cent reporting snoring on fewer nights per week.     

Efficacy of mandibular advancement device in the treatment of obstructive sleep apnea syndrome: A randomized controlled crossover clinical trial

Background

Evaluation of the efficacy and safety of a mandibular advancement device (MAD) (KlearwayTM) in the treatment of mild-to-moderate obstructive sleep apnea and chronic roncopathy.

Material and Methods

A randomized, placebo-controlled, double blinded, and crossover clinical trial was conducted. Placebo device (PD) defined as a splint in the centric occlusion that did not induce a mandibular advancement served as a control. The mandible was advanced to the maximum tolerable distance or to a minimum of 65% of the maximum protrusion. After each sequence of treatment, patients were assessed by questionnaires, conventional polysomnography, and objective measurement of snoring at the patient’s own home.

Results

Forty two patients participated in the study and 38 completed the study. Patients mean age was 46 ±9 years and the 79% were males. The mean mandibular advancement was 8.6 ±2.8 mm. Patients used the MAD and the PD for 6.4 +2.4 hours and 6.2 +2.0 hours, respectively. Secondary effects (mostly mild) occurred in the 85.7% and the 86.8% of the users of MAD and PD, respectively. The MAD induced a decrease in the apnea-hypopnea index (AHI) from 15.3 +10.2 to 11.9 +15.5. The 50% reduction in the AHI was achieved in the 46.2% and the 18.4% of the patients treated with MAD and PD, respectively. The use of the MAD induced a reduction in the AHI by 3.4 +15.9 while the PD induced an increase by 10.6 +26.1. The subjective evaluation of the roncopathy indicated an improvement by the MAD and an increase in the perceptive quality of sleep. However, the objective evaluation of the roncopathy did not show significant improvements.

Conclusions

The use of MAD is efficient to reduce the AHI and improve subjectively the roncopathy. MAD could be considered in the treatment of mild-to-moderate OSA and chronic roncopathy. Key words:Obstructive sleep apnea (OSA), mandibular advance device, treatment, efficacy, clinical assay.     

A randomized controlled trial of implant-retained mandibular overdentures

Evidence from randomized clinical trials of implant-retained overdentures is very limited at the present time. The aim of this study was to compare implant-retained mandibular overdentures and conventional complete dentures in a randomized controlled trial (RCT). Our a priori hypothesis was that implant-retained mandibular overdentures would be significantly better than conventional complete dentures. Edentulous patients (n = 118) were randomly allocated to either an Implant Group (n = 62) or a Denture Group (n = 56). Patients completed the Oral Health Impact Profile (OHIP) and a denture satisfaction scale pre-treatment and three months post-treatment. Upon completion of treatment, both groups reported improvement (p < 0.001, Wilcoxon Ranks Sum test) in oral-health-related quality of life and denture satisfaction. There were no significant post-treatment differences between the groups, but a treatment effect may be masked by application of "intention to treat" analysis. The OHIP change scores were significantly greater for patients receiving implants than for those who refused them.     

Ten-year follow-up of mandibular advancement devices for the management of snoring and sleep apnea

STATEMENT OF PROBLEM: Intraoral mandibular advancement devices have become widely used in recent years for the management of snoring and sleep apnea, and short-term effectiveness has been demonstrated. However, there is a shortage of data regarding long-term compliance. PURPOSE: The purpose of this study was to investigate the long-term compliance of patients who were provided with a mandibular advancement device. MATERIAL AND METHODS: Records of 180 patients who were provided with a mandibular advancement device in 1996 were available for review. A questionnaire was sent to all of these patients inquiring about continued device usage, comfort, and effectiveness. Questions were also asked about smoking, alcohol consumption, height, and weight. Data were analyzed with chi-square tests for any association between these factors and success of the device (alpha=.05). RESULTS: The response rate was 40%, with 72 replies. Of this number, 34 patients were currently wearing the device every night, with a further 13 wearing the device for up to 6 nights per week. Thirty-one of the respondents who were wearing the device felt more refreshed on waking. The median body mass index (BMI) was 30, 8 were smokers, and 12 subjects drank more than 20 units of alcohol per week. Few adverse effects of the device were reported. CONCLUSIONS: The mandibular advancement device appears to be an effective long-term solution for a significant number of patients with problem snoring and also those with mild to moderate obstructive sleep apnea.     

Reduction of sleep bruxism using a mandibular advancement device: an experimental controlled study

PURPOSE: The objective of this experimental study was to compare the effect on sleep bruxism and tooth-grinding activity of a double-arch temporary custom-fit mandibular advancement device (MAD) and a single maxillary occlusal splint (MOS). MATERIALS AND METHODS: Thirteen intense and frequent bruxors participated in this short-term randomized crossover controlled study. All polygraphic recordings and analyses were made in a sleep laboratory. The MOS was used as the active control condition and the MAD was used as the experimental treatment condition. Designed to temporarily manage snoring and sleep apnea, the MAD was used in 3 different configurations: (1) without the retention pin between the arches (full freedom of movement), (2) with the retention pin in a slightly advanced position (< 40%), and (3) with the retention pin in a more advanced position (> 75%) of the lower arch. Sleep variables, bruxism-related motor activity, and subjective reports (pain, comfort, oral salivation, and quality of sleep) were analyzed with analysis of variance and the Friedman test. RESULTS: A significant reduction in the number of sleep bruxism episodes per hour (decrease of 42%, P < .001) was observed with the MOS. Compared to the MOS, active MADs (with advancement) also revealed a significant reduction in sleep bruxism motor activity. However, 8 of 13 patients reported pain (localized on mandibular gums and/or anterior teeth) with active MADs. CONCLUSIONS: Short-term use of a temporary custom-fit MAD is associated with a remarkable reduction in sleep bruxism motor activity. To a smaller extent, the MOS also reduces sleep bruxism. However, the exact mechanism supporting this reduction remains to be explained. Hypotheses are oriented toward the following: dimension and configuration of the appliance, presence of pain, reduced freedom of movement, or change in the upper airway patency.     

Non-apneic snoring and the orthodontist: the effectiveness of mandibular advancement splints

OBJECTIVE: Non-apneic snoring is a very common problem, which impacts on all family members. Oral appliances have been used in the management of snoring. These posture the mandible forward during sleep, opening the airway and so reducing the potential for noise generation. This articles aims to objectively evaluate the effectiveness of mandibular advancement splints (MAS) in non-apneic snorers. DESIGN: Prospective clinical trial. SETTING: University Dental Hospital and School. SUBJECTS AND METHODS: 35 consecutively referred adults with proven non-apneic snoring. INTERVENTIONS: Subjects were fitted with a removable, adjustable Herbst MAS. MAIN OUTCOME MEASURES: Questionnaires determined changes in snoring incidence, daytime tiredness, any side effects and their duration. Eleven subjects completed overnight domiciliary sleep recordings of oxygen saturations, pulse rates and sound profile, before and 1 month after fitting the MAS. RESULTS: The questionnaires and sleep recordings suggested that the MAS significantly reduced snoring incidence (p<0.05) and improved sleep quality. Daytime tiredness, as assessed by the Epworth Sleepiness Scale, was significantly reduced (p<0.001). Initial side effects of muscular and TMJ discomforts were mostly resolved after 1 month of appliance wear. CONCLUSIONS: Use of a MAS improves snoring incidence and sleep quality in most patients with non-apneic snoring.     

Effects of a mandibular advancement device for the treatment of sleep apnea syndrome and snoring on respiratory function and sleep quality

In this study the fabrication of a simplified mandibular advancement device for sleep apnea syndrome was described. Its effect on respiratory function and sleep quality variables was evaluated polysomnographically in 256 patients with sleep apnea syndrome and snoring. Polysomnographic recordings were performed twice, before and after insertion of the oral appliance. The mean apneahypopnea index (AHI) decreased significantly (p < 0.0001) with the appliance to 18.2 from 43.2 without it. Responders defined by AHI < 10 were 54% and those defined as a 50% decrease of AHI were 66%. Oxygen saturation, duration of apnea, sleep efficiency, and total arousal were improved significantly after treatment without major side effects. The device improved significantly the respiratory function and sleep quality in patients with sleep apnea syndrome. Compliance was about 90% followed for 2.5 years. This appliance offers some advantages over other therapies because it is noninvasive, easy to fabricate, and well accepted by patients.     

Short-term effects of a mandibular advancement device on obstructive sleep apnoea: an open-label pilot trial

Obstructive sleep apnoea (OSA) is a common sleep disorder, which is, among others, associated with snoring. OSA has a considerable impact on a patient's general health and daily life. Nasal continuous positive airway pressure (nCPAP) is frequently used as a "gold standard" treatment for OSA. As an alternative, especially for mild/moderate cases, mandibular advancement devices (MADs) are prescribed increasingly. Their efficacy and effectiveness seem to be acceptable. Although some randomized clinical trials (RCTs) have been published recently, most studies so far are case studies. Therefore, our department is planning a controlled RCT, in which MADs are compared with both nCPAP and a control condition in a parallel design. As a first step, an adjustable MAD was developed with a small, more or less constant vertical dimension at different mandibular positions. To test the device and the experimental procedures, a pilot trial was performed with 10 OSA patients (six mild, four moderate; one women, nine men; mean age = 47.9 +/- 9.7 years). They all underwent a polysomnographic recording before as well as 2-14 weeks after insertion of the MAD (adjusted at 50% of the maximal protrusion). The apnoea-hypopnoea index (AHI) was significantly reduced with the MAD in situ (P = 0.017). When analysed as separate groups, the moderate cases showed a significantly larger decrease in AHI than the mild cases (P = 0.012). It was therefore concluded from this pilot study that this MAD might be an effective tool in the treatment of, especially, moderate OSA.     

Microimplant-based mandibular advancement therapy for the treatment of snoring and obstructive sleep apnea: a prospective study

Objective:To investigate the efficacy of orthodontic microimplant–based mandibular advancement therapies for the treatment of snoring and obstructive sleep apnea (OSA) in adult patients.Materials and Methods:Ten adult OSA patients (seven men, three women; mean age 60.00 ± 9.25 years) were each treated with two mandibular orthodontic microimplants attached to a customized reverse face mask for mandibular advancement. Pretreatment and posttreatment outcome measures of microimplant mobility, apnea-hypopnea index, snoring, respiratory movement, and Epworth sleepiness scores were evaluated after 6 months.Results:Highly significant reductions in the apnea-hypopnea index, snoring, and sleep variables were observed. Sixteen of the 20 (80%) microimplants were stable and showed no mobility, and four (20%) demonstrated grade 1 or 2 mobility and required removal and reinsertion of a new microimplant.Conclusions:Favorable reductions in sleep variables highlight the potential of microimplant-based mandibular advancement therapy as an alternative treatment modality for OSA patients who cannot tolerate continuous positive airway pressure and oral appliance therapy.     

A mandibular protruding device in obstructive sleep apnea and snoring

The overall purpose behind treatment in sleep-breathing disorders is to ease breathing and thereby reduce the risk of morbidity. The mandibular protruding device (MPD) is one method of treating both obstructive sleep apnea (OSA) and snoring. The aims of the studies were to study MPD users after 2 years and evaluate the following aspects of the MPD: subjective and objective effects on sleep, influences on airway passages and hard tissues, and the incidence and types of adverse events of the masticatory system including temporomandibular disorders. Further aims were to evaluate the impact of body posture and the effects of the MPD on pharyngeal width and to validate two methods for measuring mandibular protrusion and MPD advancement. MATERIALS AND METHODS: Seventy-seven subjects with OSA or snorers without OSA. were admitted to the study after a medical examination, which included a somnographic registration. The patients completed questionnaires regarding sleep quality and symptoms from the masticatory system, and underwent a clinical jaw function examination, were given an MPD, and were subjected to lateral cephalometric examination. Two follow-ups, 6 months and 2 years after MPD treatment were conducted. The study population comprised 65 patients at the 2-year follow-up. RESULTS: At the 2-year follow-up, a significant reduction of the subjective complaints was noted by 90% of the MPD users. In the objective evaluation, the oxygen desaturation index (ODI) of the OSA group (n = 39) decreased significantly from a mean of 14.7 to 3.1 and the mean arterial oxygen saturation (SaO2) increased significantly from 78% to 89%. The snorers maintained their initial values. In the total group, MPD treatment significantly increased most pharyngeal measures and lifted the hyoid bone. The pharyngeal area decreased significantly--by more than 50%--when the patient was supine, and the velum area increased significantly. At the 2-year follow-up, on upright cephalogram without MPD, the pharyngeal area had significantly increased and the velum area had significantly decreased. The mandible was posteriorly rotated (P < 0.01) as well as the lower incisors were proclined (P < 0.05). Mandibular advancement and vertical opening with an MPD, as measured with a ruler, compared well with measurements taken from a cephalogram. At the 2-year follow-up significant changes in the mean mandibular range of protrusion (+0.6 mm), overjet (-0.5 mm), and overbite (-0.8 mm) were registered. Nine of the 65 patients had developed a lateral open bite, and 2 were aware of the change. The reported frequency of headache was significantly reduced. At the 2-year follow-up there was a significant reduction in pain during mandibular movements. CONCLUSIONS: MPD treatment significantly reduced subjective complaints of sleep disturbances and significantly reduced ODI values among OSA patients. A high MPD compliance rate after 2 years (84%) indicated a well-tolerated treatment and a low rate of side effects were noted. The key factor in OSA and snoring is the obstruction of pharynx. The MPD treatment significantly increased the pharyngeal passages and significantly reduced the size of velum and thereby facilitated the breathing.     

Chrome cobalt mandibular advancement appliances for managing snoring and obstructive sleep apnea

Snoring and sleep apnea are chronic conditions. This article describes the use of cobalt chrome mandibular advancement appliances as a long-term, robust addition to the appliances used to treat these conditions. The clinical indications, appliance design, construction stages and special features of using cast alloy bases are described.     

Incremental versus maximum bite advancement during twin-block therapy: a randomized controlled clinical trial.

The aim of this study was to evaluate the effectiveness of incremental and maximum bite advancement during treatment of Class II Division 1 malocclusion with the Twin-block appliance in the permanent dentition. It was performed at 3 district general hospitals in the United Kingdom with 4 operators. Two hundred three patients, 10-14 years old, were randomized. Control patients had the initial bite taken edge-to-edge for appliance construction with a standard Twin-block. Experimental patients had 2 mm initial bite advancement and subsequent 2 mm advancements at 6 weekly intervals with a Twin-block appliance incorporating advancement screws. Data were collected at the start and the finish of Twin-block treatment. The use of incremental advancement of the Twin-block did not confer any advantages in terms of process and outcome of the treatment. However, patient compliance was influenced by operator and patient age. The duration of treatment was influenced by operator and initial overjet. Incremental bite advancement produced no advantages over maximum advancement.     

Biomechanical effects of a mandibular advancement device on the temporomandibular joint

Purpose

Mandibular advancement devices are commonly used in the treatment of patients with mild to moderate obstructive sleep apnea (OSA). Designed to maintain the mandible in forced protrusion while being worn, mandibular advancement devices (MADs) are intended to increase the upper airway during sleep, thereby reducing OSA symptoms. Depending on the extent of mandibular protrusion, side effects including temporomandibular joint dysfunction are frequently reported. These are likely to reduce overall treatment success by affecting therapeutic adherence.

Postoperative stability of two common ramus osteotomy procedures for the correction of mandibular prognathism: A randomized controlled trial

The aim of this randomized controlled trial was to compare the skeletal stability between sagittal split ramus osteotomy (SSRO) and intraoral vertical ramus osteotomy (IVRO) in the treatment of mandibular prognathism. Patients presenting with mandibular prognathism and scheduled for orthognathic surgery were randomized into either the SSRO group or the IVRO group. Changes at B-point were assessed by serial tracing of lateral cephalograms, which were taken preoperatively, and at 2 weeks, 6 months, 1 year, and 2 years postoperatively. Ninety-eight patients were recruited, with 49 patients in each group. Between 2 weeks and 6 months postoperatively, there was significantly more surgical relapse in the horizontal direction (anterior movement) in the SSRO group when compared with the IVRO group (1.83 mm (SD 2.91 mm) vs 0.49 mm (SD 2.32 mm); p = 0.019). At 2 years, there was more surgical relapse in the horizontal direction in the SSRO group than in the IVRO group (0.27 mm (SD 0.34 mm) vs 0.10 mm (SD 0.29 mm); p = 0.014). There were also more absolute changes (irrespective of direction) at B-point in the SSRO group than in the IVRO group at postoperative 6 months, 1 year, and 2 years (p = 0.016, 0.049, and 0.045, respectively). The amounts of change at B-point as percentages of total mandibular setback were 1.3% and 3.5% in the IVRO group and SSRO group, respectively. There were no differences in vertical changes between the two groups at any time points. In conclusion, the horizontal stability at B-point was shown to be superior in the IVRO group compared with the SSRO group in the correction of mandibular prognathism during the 2-year follow-up. Although the exact clinical importance of this difference is unknown at this time, this possible benefit may be an important key factor when deciding which osteotomy technique to employ for mandibular setback.     

Use of a mandibular advancement device in obstructive sleep apnoea

The present study investigated the effectiveness of an intra-oral mandibular advancement device in the treatment of patients with obstructive sleep apnoea (OSA) who could not tolerate or who had failed to comply with continuous positive airway pressure (CPAP). Thirty-five patients diagnosed by sleep study as suffering from OSA, who had either been unable to tolerate or had been non-compliant with CPAP treatment, were included in the study. The subjects completed an Epworth sleep questionnaire. The subjects then had an oral appliance made. After using the appliance for 3 months, the patients repeated the questionnaires and had a repeat sleep study performed with the oral appliance in situ. Thirty-one subjects completed the investigation. Mean AHI pre- and post-study were 26.64 and 24.06, respectively (P > 0.05). Mean Epworth scores pre- and post-study were 16.32 and 14.64, respectively (P > 0.05). Those patients with a pre-study AHI < 20 (n = 23), however, did significantly better with the appliance (P < 0.0001). Those patients with a pre-study AHI > 20 did not benefit from this device (P > 0.05). The main problems encountered were initial jaw discomfort in 18 patients and dry mouth in 11 patients (both of which improved with continued usage). It was concluded that the type of appliance used in this study can be recommended for those with mild OSA who are unable to tolerate CPAP.     

Effects of a mandibular advancement device on the upper airway morphology: a cephalometric analysis

Summary  The aims of this study were to assess changes in the upper airway morphology associated with an oral appliance in situ in patients suffering from the obstructive sleep apnoea–hypopnoea syndrome and to relate these changes to treatment response. Changes in upper airway morphology as a result of an oral appliance were assessed in 52 patients with obstructive sleep apnoea–hypopnoea syndrome by means of cephalometric analysis. Lateral cephalograms were taken at baseline and after 2–3 months of treatment. Baseline and follow-up cephalograms were traced twice and cephalometric variables were compared. The predictive value of changes in upper airway morphology for the treatment response was evaluated in univariate and multivariate regression analyses. Oral appliance therapy resulted in an increased posterior airway space at the level of the second vertebra, the uvular tip and the base of the tongue. The increase of the posterior airway space at the level of the second vertebra and the uvular tip were the best predictors for relative improvement of the apnoea–hypopnoea index. However, the predictive value for treatment response of these cephalometric upper airway changes should be interpreted with caution.     

Evaluation of the safety and efficacy of an automated flossing device: a randomized controlled trial

OBJECTIVE: To evaluate the safety and efficacy of a newly developed automated flossing device (AF). METHODOLOGY: Subjects were recruited from a university campus via announcements, and were randomly assigned to a control (C), manual (M), or automated (A) group. Subjects brushed twice a day and treatment groups used their respective floss daily. The safety assessment (SA), plaque index (PI), and gingival index (GI) were measured at days one, 15, and 30. A pre- and post-intervention PI was measured at days 15 and 30. RESULTS: The majority of subjects (n=76) were students, mean age +/- SD of 23.3 +/- 5.2 years. Based on one-way analysis of covariance, C had a higher mean PI score than A at days 15 (p = 0.019) and 30 (p < 0.001), and M had a higher mean PI score than A at day 30 (p = 0.022). The C had a higher mean GI score than A at day 30 (p = 0.034). The SA included trauma associated with improper use of the AF for two subjects. CONCLUSION: At four weeks, the AF removed more interproximal plaque than M, and there was less interdental inflammation compared to brushing alone. The AF is safe and effective when used properly, and demonstrates great promise as an alternative to manual floss.