Oral appliance versus continuous positive airway pressure in obstructive sleep apnea syndrome: a 2-year follow-up.

STUDY OBJECTIVES: Oral appliance therapy has emerged as an important alternative to continuous positive airway pressure (CPAP) in treating patients with obstructive sleep apnea syndrome (OSAS). In this study we report about the subjective and objective treatment outcome of oral appliance therapy and CPAP in patients with OSAS. DESIGN: Cohort study of a previously conducted randomized clinical trial. SETTING: University Medical Center, Groningen, The Netherlands. PATIENTS OR PARTICIPANTS: One hundred three patients with OSAS. INTERVENTIONS: CPAP and oral appliance therapy (Thornton Adjustable Positioner type-1, Airway Management, Inc., Dallas, TX, USA). MEASUREMENTS AND RESULTS: Objective (polysomnography) and subjective (Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, Medical Outcomes Study 36-item Short Form Health Survey [SF-36]) parameters were assessed after 1 and 2 years of treatment. Treatment was considered successful when the apnea-hypopnea index (AHI) was < 5 or showed substantial reduction, defined as reduction in the index of at least 50% from the baseline value to a value of < 20 in a patient without OSAS symptoms while undergoing therapy. Regarding the proportions of successful treatments, no significant difference was found between oral appliance therapy and CPAP in treating mild to severe OSAS in a 2-year follow-up. More patients (not significant) dropped out under oral appliance therapy (47%) compared with CPAP (33%). Both therapies showed substantial improvements in polysomnographic and neurobehavioral outcomes. However, CPAP was more effective in lowering the AHI and showed higher oxyhemoglobin saturation levels compared to oral appliance therapy (P < 0.05). CONCLUSIONS: Oral appliance therapy should be considered as a viable treatment alternative to continuous positive airway pressure (CPAP) in patients with mild to moderate obstructive sleep apnea syndrome (OSAS). In patients with severe OSAS, CPAP remains the treatment of first choice. CLINICAL TRIAL INFORMATION: The original randomized clinical trial, of which this study is a 2-year follow-up, is registered at ISRCTN.org; identifier: ISRCTN18174167; trial name: Management of the obstructive sleep apnea-hypopnea syndrome: oral appliance versus continuous positive airway pressure therapy; URL: http://www.controlled-trials.com/ISRCTN18174167.

Groningen temporomandibular total joint prosthesis: an 8-year longitudinal follow-up on function and pain.

Total temporomandibular joint replacement is a surgical procedure for patients with severe temporomandibular joint afflictions affecting quality of life, which have not responded beneficially to previous conventional surgery. The aim of this study was to assess the long-term outcome of the Groningen temporomandibular joint (TMJ) prosthesis in patients with chronic pain and mutilated temporomandibular joints following multiple surgical procedures, with respect to prosthesis failure, the patient's postoperative level of satisfaction and longitudinal changes in maximum mouth opening, functional mandibular impairment and pain. Eight female patients were studied in whom Groningen TMJ prostheses were inserted, two unilaterally and six bilaterally. The Groningen TMJ prosthesis was mechanically successful during 8 years of follow-up in seven out of eight patients with a disc dislocation being seen in one patient (7%). Patients were satisfied, despite the limited improvement of the maximum mouth opening, and pain scores. Although the decline of MFIQ scores during 8 years of follow-up was significant compared to baseline (p=0.027), the effects of the prosthesis on maximum mouth opening, function and pain were limited. This may be due to persistent chronic pain and the adverse effects of multiple previous surgical procedures.

Long-term oral appliance therapy in obstructive sleep apnea syndrome: a controlled study on temporomandibular side effects.

The objective of this study was to assess variations in the occurrence of temporomandibular disorders (TMDs) and the risk of developing pain and function impairment of the temporomandibular complex in obstructive sleep apnea syndrome (OSAS) patients treated with either an oral appliance (mandibular advancement device) or continuous positive airway pressure (CPAP) in a 2-year follow-up study. In addition, we assessed the relationship between the mean mandibular protrusion and the frequency of wearing the appliance during follow-up with the occurrence of pain and function impairment of the temporomandibular complex. Fifty-one patients were randomized to oral appliance therapy and 52 patients to CPAP therapy. TMDs (diagnosed according to the Axis I Research Diagnostic Criteria for TMD), pain intensity and disability and mandibular function impairment were recorded at baseline, after 2 months, 1 year and 2 years of therapy. Only in the initial period of treatment the occurrence of pain-related TMDs was considerably higher (24%) in the oral appliance group compared to CPAP (6%). Oral appliance therapy furthermore resulted in more temporomandibular pain compared to CPAP (odds ratio 2.33, 95% confidence interval (1.22-4.43)). However, there were no limitations in mandibular function in both groups during the (entire) follow-up period. Although generally not serious and of transient nature, oral appliance therapy results in more pain-related TMDs in the initial period of use compared with CPAP therapy. Oral appliance therapy is associated with increased pain in the temporomandibular complex in the initial period of use. Because of the transient nature, this pain is not a reason to contra-indicate an oral appliance in OSAS patients. Moreover, TMDs and the risk of developing pain and function impairment of the temporomandibular complex appear limited with long-term oral appliance use.

Effects of oral appliances and CPAP on the left ventricle and natriuretic peptides.

BACKGROUND: In patients without cardiac disease, obstructive sleep apnea-hypopnea syndrome (OSAHS) is associated with systolic and diastolic dysfunction and left ventricular hypertrophy. Although continuous positive airway pressure (CPAP) therapy has been demonstrated to improve left ventricular structure and function in these patients, the effects of oral-appliance therapy on cardiac function are largely unknown. The aims of this study were to determine the left ventricular structure and function and natriuretic peptides in untreated OSAHS patients without cardiovascular disease, and to compare the effects of oral-appliance with CPAP therapy. METHODS: In 28 moderate to severe OSAHS patients echocardiography and measurements of concentrations of the amino-terminal fragment of pro-brain natriuretic peptide (NT-pro-BNP) were performed. Fifteen patients were randomized to oral-appliance and 13 to CPAP therapy. After 2 to 3 months of treatment echocardiography and NT-pro-BNP measurements were repeated. RESULTS: Of the 28 patients, 7 had left ventricular hypertrophy, 6 had left ventricular dilatation, and 3 had elevated NT-pro-BNP values. No significant improvements in echocardiographic outcomes were observed following treatment. The median NT-pro-BNP values improved significantly following oral-appliance therapy (52 pg/ml to 22 pg/ml) whereas not following CPAP therapy (31 pg/ml to 37 pg/ml). CONCLUSIONS: This study demonstrates that 50% of patients with moderate to severe OSASH, without cardiovascular disease, have left ventricular hypertrophy, left ventricular dilatation or elevated natriuretic peptides. Significant changes in NT-pro-BNP values indicate an improvement of cardiac function following effective oral-appliance therapy.

The effect of intra-articular injection of ultracain in the temporomandibular joint in patients with preauricular pain: a randomized prospective double-blind placebo-controlled crossover study.

OBJECTIVES: To evaluate the distinguishing ability of intra-articular anesthesia from placebo in orofacial pain patients with pain located in the temporomandibular joint (TMJ) region, aiming at a validation of intra-articular anesthesia injection as a diagnostic test of pain in the TMJ region. MATERIALS AND METHODS: A randomized prospective double-blind, placebo-controlled crossover study was conducted among 19 patients (18 females, 1 male) with pain in the TMJ region. The short-term effects of intra-articular ultracain and saline injections on pain and maximum mouth opening were measured and analyzed. RESULTS: Compared with placebo injections, a statistically significant difference in pain scores was found after intra-articular injection of a local anesthetic on Visual Analog Scale values. The maximum mouth opening scores did, however, not differ between the 2 groups. DISCUSSION: TMJ injection with local anesthesia leads to the decrease of pain in patients with preauricular pain. To establish the source of pain, injection of a local anesthetic in the TMJ may be used as a diagnostic tool. However, the results of diagnostic injections should still be interpreted cautiously.

Simulated driving in obstructive sleep apnoea-hypopnoea; effects of oral appliances and continuous positive airway pressure.

Impaired simulated driving performance has been demonstrated in obstructive sleep apnoea-hypopnoea syndrome (OSAHS) patients. Although continuous positive airway pressure (CPAP) generally improves simulated driving performance, the effects of oral-appliance (OA) therapy are unknown. The aims of this study were to determine to what extent OSAHS patients have more difficulty with a monotonous simulated driving test when compared with control subjects and to compare the effects of OA with CPAP therapy. Simulated driving performance was evaluated in 20 OSAHS patients and 16 control subjects during a 25-min driving test. After randomization, ten patients started OA and CPAP therapy, respectively. After 2 to 3 months of treatment, patients repeated the driving test. At baseline, the total number of lapses of attention during driving was significantly higher in OSAHS patients as compared with control subjects. As a result of treatment, the total number of lapses of attention was significantly decreased in both the OA and CPAP group. When comparing driving performance between the OA and CPAP group, no significant differences were noted. OSAHS patients perform worse on a simulated driving test when compared with control subjects. When evaluating the effects of treatment, adequate OSAHS management with either OA or CPAP therapy usually resulted in substantial improvements of simulated driving. Conclusions beyond both treatments improving simulated driving performance are, however, not justified by the data in the present study.

Sexual function and obstructive sleep apnea-hypopnea: a randomized clinical trial evaluating the effects of oral-appliance and continuous positive airway pressure therapy.

INTRODUCTION: The obstructive sleep apnea-hypopnea syndrome (OSAHS) is associated with sexual dysfunction. Although successful treatment with continuous positive airway pressure (CPAP) has been demonstrated to improve sexual function, the effects of oral-appliance therapy are unknown. AIM: The aims of this study were to determine to what extent untreated male OSAHS patients experience sexual dysfunctions compared with control subjects, and second, to evaluate the effects of oral-appliance and CPAP therapy on sexual functioning. METHODS: Sexual functioning was determined in 48 OSAHS patients with the Golombok Rust inventory of sexual satisfaction (GRISS) and a testosterone measurement. GRISS outcomes were compared with 48 age-matched male controls without any sexual problems. Patients were randomized for either oral-appliance or CPAP therapy. After 2-3 months of treatment, the GRISS and testosterone measurements were repeated. MAIN OUTCOME MEASURE: The outcomes on the GRISS were used as the main outcome measure. RESULTS: Compared with controls, OSAHS patients had significantly more erectile dysfunction (mean +/- standard deviation; OSAHS 8.7 +/- 3.8 vs. controls 6.8 +/- 2.6) and sexual dissatisfaction (mean +/- standard deviation; OSAHS 9.7 +/- 4.2 vs. controls 8.1 +/- 2.6) as indicated by the GRISS. No significant changes in the GRISS or testosterone levels were observed in the 20 and 27 patients completing the follow-up review for oral-appliance and CPAP therapy. A correlation was demonstrated between the extent of erectile dysfunction at baseline and improvements in erectile function following treatment (r = -0.547, P = 0.000). CONCLUSIONS: This study confirms that male OSAHS patients show more sexual dysfunctions compared with age-matched control subjects. Although significant improvements in sexual functioning in neither the oral-appliance nor CPAP-treated group could be established, our findings suggest that untreated OSAHS patients with pronounced erectile dysfunction experience some improvement following treatment.

Oral appliances and maxillomandibular advancement surgery: an alternative treatment protocol for the obstructive sleep apnea-hypopnea syndrome.

PURPOSE: The present study comprises a retrospective evaluation of the potential application of mandibular repositioning appliance (MRA) therapy preceding maxillomandibular advancement (MMA) surgery in the treatment of the Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS). Our initial experiences with a new surgical protocol, in which MRA therapy serves as a predictor for success of MMA surgery, are reported. PATIENTS AND METHODS: Forty-three consecutive patients with OSAHS treated with MRA therapy were considered for inclusion (mean+/-SD; Apnea-Hypopnea Index [AHI]=27+/-20; age=53+/-9 years). All patients displaying a substantial improvement in their AHI with MRA therapy (ie,>50% reduction) who preferred surgical rather than "prosthetic" advancement of the mandible were offered MMA surgery. Accordingly, 4 out of 43 patients were treated with MMA surgery. The AHI was used as the primary outcome measure, with MMA surgery being considered successful in case of a postoperative AHI <5. RESULTS: All 4 patients included displayed substantial improvement in their AHI following MRA therapy. Moreover, in 3 patients MRA therapy resulted in a post-treatment AHI

Prevalence of obstructive sleep apnoea following head and neck cancer treatment: a cross-sectional study.

The obstructive sleep apnoea-hypopnoea syndrome (OSAHS) is a sleep-related breathing disorder characterised by repetitive pharyngeal collapse. OSAHS is associated with a reduced quality of life. A high OSAHS prevalence has been reported in patients treated for head and neck cancer (HNC). The aim of the present study was to identify the prevalence of OSAHS within a Dutch population of patients treated for HNC. Consecutive HNC patients with a follow-up of 6 months to 5 years after treatment of an oral or oropharynx carcinoma were eligible for inclusion. Two questionnaires were used to assess the presence of OSAHS-related complaints. Subsequently, polysomnography was used in patients with OSAHS-related complaints to confirm the diagnosis of OSAHS. Four out of 33 included patients were diagnosed with OSAHS, yielding a prevalence of 12%. Since recognition and treatment of OSAHS might play an important role in improving quality of life of HNC patients, we suggest screening all patients with an oral or oropharynx carcinoma for the presence of OSAHS-related complaints prior to and following HNC treatment.

Effect of an intraoral retrusion plate on maxillary arch dimensions in complete bilateral cleft lip and palate patients.

OBJECTIVE: The aim of this study was to analyze maxillary arch dimensions in patients with complete bilateral cleft lip and palate treated with an intraoral retrusion plate prior to lip closure. PATIENTS: The effects of the intraoral retrusion plate were evaluated on serially obtained maxillary casts of 14 patients with complete bilateral cleft lip and palate. RESULTS: The Student's t test for dependent observations showed a significant decrease in distance between the premaxilla and the cleft lateral segments during active treatment. This decrease correlated with an increase in deviation of the premaxilla in relation to the vomer. For each millimeter decrease in distance between the premaxilla and the cleft lateral segments, an average increase in deviation of 4.0 degrees was found. Left and right cleft widths decreased significantly, premaxillary width increased significantly, and transverse dimensions did not change significantly. CONCLUSION: From this study it can be concluded that active presurgical treatment with an intraoral retrusion plate induces a significant decrease in distance between the premaxilla and the lateral segments. This decrease is frequently accompanied by an increase in deviation of the premaxilla relative to the vomer.

Does ultrasound stimulate osteoconduction? A placebo-controlled single-blind study using collagen membranes in the rat mandible.

PURPOSE: To investigate whether ultrasound can stimulate osteoconduction in the mandible, an attempt was made to stimulate the osteoconductive process with low-intensity pulsed ultrasound in rats. MATERIALS AND METHODS: In 64 rats, a 5.0-mm diameter circular mandibular defect was made in the ramus and, subsequently, covered on both sides with collagen membranes. Two groups were studied, an ultrasound treatment group and a placebo treatment group. At 2 and 4 weeks, the remaining defect area was measured using microradiographs, and the amount of osteoconduction was expressed as the percentage of defect closure. RESULTS: At 2 and 4 weeks, there was no significant difference in the percentage of defect closure between the groups. DISCUSSION: An explanation may be that ultrasound does not exert an effect in an area where wound healing is already expected to be at an optimal level. CONCLUSION: There was no evidence that low-intensity pulsed ultrasound stimulates osteoconduction in a bone defect in the rat mandible that is covered by a collagen membrane.

Ultrasound to stimulate early bone formation in a distraction gap: a double blind randomised clinical pilot trial in the edentulous mandible.

OBJECTIVE: In a double blind randomised clinical pilot trial, it was investigated whether low intensity pulsed ultrasound therapy stimulates early bone formation in a distraction gap created in a severely resorbed mandible. DESIGN: Eight patients underwent a mandibular vertical distraction over an average distance of 6.6+/-1.1mm. Ultrasound self-therapy or placebo therapy was started on the first day of distraction and continued daily until the implants were inserted. After 31+/-3.8 days of consolidation, the distraction device was removed, a transmandibular biopsy was taken, and two endosseous implants were inserted. RESULTS: All patients complied well with ultrasound therapy. During an average of 30.1+/-4.1 months follow-up, no complications did occur. Microradiographic examination of the biopsies revealed a comparable mean area of mineralised tissue in the distraction gap of 1.9+/-1.7mm(2) in the ultrasound treatment group and 1.9+/-1.3mm(2) in the placebo treatment group. Histological examination indicated that active woven bone was present within the distraction gap just adjacent to the osteotomy plane, with no apparent differences between the treatment groups. The lamellar bone formation outside the distraction gap appeared to have started as well. CONCLUSION: During a 31-day consolidation period, ultrasound treatment does not appear to stimulate bone formation in the severely resorbed vertical distracted mandible and it seems that this period is too short to evaluate properly if there is an effect. Therefore, a longer consolidation period has to be studied.

Crosslinking of fibrinogen and fibronectin by free radicals: a possible initial step in adhesion formation in osteoarthritis of the temporomandibular joint.

PURPOSE: Adhesion formation in osteoarthritis (OA) of the temporomandibular joint (TMJ) typically results in a sustained limitation of joint movement. We propose the hypothesis that free-radical-mediated crosslinking of proteins underlies this adhesion formation in affected joints. Free radicals may cause oxidative modification of proteins, creating an opportunity for the formation of intramolecular and intermolecular crosslinks via covalent bonds. This may stabilize protein aggregates, rendering them more resistant to degradation. In this study, the free-radical-mediated crosslinking of model proteins (fibrinogen and fibronectin) was investigated to test our hypothesis that free radicals contribute to adhesion formation via this mechanism in OA of the TMJ. MATERIALS AND METHODS: Physiological clot formation of fibrinogen by thrombin and free-radical-induced crosslinking of fibrinogen and of fibronectin were analyzed using spectrophotometric turbidity measurements, light-scattering techniques, polyacrylamide gel electrophoresis (PAGE), and rotary shadowing. RESULTS: Fibrinogen was shown to aggregate after free radical treatment, as detected using turbidity measurements and light-scattering techniques. Using PAGE, fibrinogen as well as fibronectin was shown to degrade under low oxidative stress. Under high oxidative stress, however, fragments from both proteins were found to be covalently crosslinked, resulting in high-molecular-weight protein aggregates. The aggregation was shown to be at random with rotary shadowing. CONCLUSION: The study shows that high oxidative stress contributes to the formation of crosslinked proteins that may serve as an initial scaffolding for the development of adhesions frequently seen in OA of the TMJ.

Repeated assessment of temporomandibular joint pain: reasoned decision-making with use of unidimensional and multidimensional pain scales.

BACKGROUND: There are no reports in the literature about patients with painfully restricted temporomandibular joints concerning the reliability of unidimensional and multidimensional pain scales on the basis of a generalizability and decision study. Generalizability and decision studies are designed to aid in reasoned decision-making and therefore are complementary to classic psychometric analyses, in which correlation coefficients express the reliability of a measurement design. The smallest detectable difference as an outcome of the decision study is the smallest statistically significant change that can be detected. PATIENTS: Twenty-five consecutive patients (5 males and 20 females) with painfully restricted mandibular function participated in the current study. DESIGN: Repeated measurements of three levels of unidimensional experienced pain (average, minimal, and maximal pain before the week of assessment; n = 200) and the multidimensional pain rating index of the MPQ (n = 100) were used. The measurement sessions were supervised by two observers on two separate measurement days, 1 week apart, with each measurement repeated twice. RESULTS: Inconsistency in measurement results analyzed in terms of absolute error variance (i.e., the measurement facets plus all the interactions) represented at least 24% of total variance. The smallest detectable difference of visual analog scales varied from 43 to 15 mm, depending on the amount of repetitions, whereas for the pain rating index it varied from 22.7 to 14.4 units. CONCLUSIONS: For statistically and clinically successful treatment of patients with painfully restricted temporomandibular joints, clinicians must overcome at least the smallest detectable difference and 38% of the initial average pain level.