A Design of Oral Appliance for Obstructive Sleep Apnea (Preprint)

BACKGROUND As per the current epidemiological studies, the prevalence of obstructive sleep apnea (OSA) among the adult population is very high. Oral appliances (OA) has emerged as the most recommended alternative treatment option for mild to moderate OSA. OBJECTIVE The objective of this article is to develop a new design of OA named “customized maxillary oral appliance”, for managing moderate obstructive sleep apnea (OSA) syndrome. METHODS The design proposed in this clinical technique is first of its kind that is fabricated on the maxillary arch. Customized maxillary oral appliance is developed by combining the principles of the three most popular OA’s used in OSA, namely soft palate lifters, tongue retaining devices, and mandibular advancement devices. RESULTS A new design of OA for the maxillary arch is proposed for managing moderate OSA. CONCLUSIONS Given the potential impact of OSA on general and mental health and the side effects of existing appliances there is a need for a new remedy to be introduced in the field of sleep medicine. This novel design can provide a new therapeutic op¬tion for patients with moderate OSA. CLINICALTRIAL Trial Registration: CTRI/2020/07/026936 Registered 31 July 2020, http://ctri.nic.in/Clinicaltrials/regtrial.php?modid=1&amp;compid=19&amp;EncHid=90265.33636 </sec

Evaluating the Effect of Complete Dentures on Signs and Symptoms of Temporomandibular Disorders Analyzed by Craniomandibular Index in Completely Edentulous Patients- A Study Protocol

Background: A Temporo-mandibular disorder (TMD) itself is a cumulative terminology used to indicate the situations which entails the pain alone or in association with dysfunction of the Temporomandibular joint (TMJ) with or without involving the associated structures. One of the main cause of developing TMD is the loss of tooth. The completely edentulous patients also have reported high prevalence of TMD as in dentulous patients. &#x0D; Methods: It is a prospective interventional study that will be carried out in three years. The sample size will be those completely edentulous subjects, who has not used dentures for a duration of  six  months to five years  of tooth extraction. Such subjects will then be subjected to anamnestic component of Helkimos Index for screening purpose.110 subjects exhibiting mild to severe signs and symptoms of Temporomandibular disorders will be considered as the study participants for the study. Study participants will be categorized as Group A (study participants having mild symptoms of TMD, n=55) and the second will be Group B (study participaants having severe symptoms of TMD, n=55). The Craniomandibular Index will be used to score the severity of the TMD before denture insertion. The initial recorded score will be then correlated with the score obtained after 3 months of delivery of denture. Descriptive as well as analytical statistics will be performed. The statistical relevance among the Group A and Group B before intervention and after 3months of intervention will be assessed at p&lt;0.05. &#x0D; Discussion: Through the study results we anticipate a fall in CMI score i.e improvement by lowering the intensity of TMD due to intervention by complete dentures in completely edentulous subjects. In case the above Hypothesis is not proved, then prevalence of TMD among patients who are completely edentulous needs to be anticipated with the factors such as anatomical or pathological diversities in TMJ and not to be associated with changes in vertical dimensions because of teeth loss.</jats:p

Assessing the Efficacy of Customized Maxillary Oral Appliance With Mandibular Advancement Device in Moderate Obstructive Sleep Apnea: Protocol for a Randomized Controlled Trial (Preprint)

BACKGROUND Obstructive sleep apnea (OSA) is due to the obstruction of the upper airway during sleep. This condition is often associated with multiple symptoms and co-morbidities. There are many treatment options mentioned in the literature to manage OSA, among which interventional option of continuous positive airflow (CPAP) and non-interventional option i.e, Mandibular advancement device (MAD), which is an oral appliance (OA) are most preferred ones. OBJECTIVE To evaluate the efficacy of customized maxillary Oral appliance compared with mandibular advancement devices in moderate OSA patients. METHODS A Prospective Interventional study with a randomized controlled trial will be carried out involving 40 participants (sample size), with an apnea hypopnea index (AHI) &gt;15–30, recorded on Polysomnography (PSG). Study participants will be randomly divided into following treatment groups: control group or group subjected to mandibular advancement device (MAD, n=20) and second group subjected to customized maxillary oral appliance (n=20). Baseline assessment of Apnea/hypopnea index (AHI), oxygen saturation in blood, percentage of rapid eye movement, electroencephalogram, electrocardiogram, oro-nasal airflow via a pressure transducer, and Epworth sleepiness scale will be done. Then both study group participants will receive their respective appliances. And after one month and three months of delivery of appliance, all the parameters i.e AHI, oxygen saturation in blood, percentage of rapid eye movement, electroencephalogram, electrocardiogram, oro-nasal airflow via a pressure transducer, and Epworth sleepiness scale will be re-evaluated and compared with the baseline measurements. RESULTS The study has been approved by the Institutional Ethical Committee and is registration in the Clinical Trial Registry of India (CTRI) for randomized control trial (RCT). Descriptive and analytical statistics will be done. SPSS (Statistical Package for Social Sciences) Version 20.1 will be used as statistical software. The statistical significance between the two groups after one month and three months will be evaluated at P&lt; .05. We expect, customized maxillary oral appliance to be more efficient in managing moderate OSA, in comparison with MAD. CONCLUSIONS If the hypothesis of the present study is confirmed, then this customized maxillary appliance will be quoted as a “gold standard” for managing moderate OSA. CLINICALTRIAL CTRI/2020/07/026936 Registered 31 July 2020, http://ctri.nic.in/Clinicaltrials/regtrial.php?modid=1&amp;compid=19&amp;EncHid=90265.33636 INTERNATIONAL REGISTERED REPORT PRR1-10.2196/22383 </sec

Comparative evaluation of the efficacy of customized maxillary oral appliance with mandibular advancement appliance as a treatment modality for moderate obstructive sleep apnea patients—a randomized controlled trial

Abstract Background Obstructive sleep apnea (OSA) is quite common among the adult population, according to recent epidemiological studies. The most frequently suggested alternate treatment for mild to moderate OSA is oral appliances (OA). The purpose of the present study was to assess as well as compare the effectiveness of custom-made maxillary oral appliances against mandibular advancement appliances in the care of individuals suffering from moderate obstructive sleep apnea. Methods A prospective interventional research was carried out with 40 participants. Polysomnography (PSG) was done and the participants with an apnea-hypopnea index (AHI) &gt;15–30 were involved in the research. Study participants were randomly split up into two test groups: group I was the “Control Group” (group treated with a mandibular advancement device (MAD), n=20), while group II was exposed to a “customized maxillary oral appliance” (CMOA, n=20). Both groups had reference measures for AHI, blood oxygen saturation (SpO2), oro-nasal airflow via respiratory disturbance index (RDI), and the Epworth Sleepiness Scale (ESS). Appliances were fabricated and delivered to the respective study group participants. PSG was again conducted after a period of 1 and 3 months of appliance delivery and re-evaluation was done for all the parameters and was compared with reference measurements. The facts were analyzed using descriptive and analytical statistical methods. The statistical program utilized in the study was “SPSS (Statistical Package for Social Sciences) Version 20.1.” After 1 and 3 months, the statistical significance between the two study groups was assessed at P&lt;0.05. Results The analysis of mean AHI, SPO2, RDI, and ESS for both test groups manifested statistically significant measures (P&lt;0.001). The study results revealed a statistically significant depletion in mean AHI scores, improvement in mean SPO2 scores, and reduction in mean RDI scores and ESS scores when compared with reference measurements to 1 month, 1 to 3 months, and between reference measurements and 3 months. Conclusion The CMOA was effective in managing moderate OSA and has great therapeutic potential. It can be an option for the MAD for treating patients suffering from moderate obstructive sleep apnea. Trial registration The study was registered under Clinical Trials Registry-India and the registration number is CTRI/2020/07/026936. Registered on 31 July 2020 </jats:sec

Comparative evaluation of the efficacy of customized maxillary oral appliance with mandibular advancement appliance as a treatment modality for moderate obstructive sleep apnea patients—protocol for a randomized controlled trial

AbstractBackgroundObstructive sleep apnea (OSA) is due to the obstruction of the upper airway during sleep. This condition is often associated with multiple symptoms and co-morbidities. There are many treatment options mentioned in the literature to manage OSA, among which interventional option of continuous positive airflow (CPAP) and non-interventional option, i.e., mandibular advancement device (MAD), which is an oral appliance (OA), are the most preferred ones. This study aims to evaluate the efficacy of customized maxillary oral appliances with mandibular advancement devices in moderate OSA patients.MethodsA prospective interventional study with a randomized controlled trial will be carried out involving 40 participants (sample size), with an apnea-hypopnea index (AHI) &gt; 15–30, recorded on polysomnography (PSG). Study participants will be randomly divided into the following treatment groups: control group or group subjected to mandibular advancement device (MAD,n=20) and second group subjected to customized maxillary oral appliance (CMOA,n=20). Baseline assessment of apnea/hypopnea index (AHI), oxygen saturation in blood, percentage of rapid eye movement, electroencephalogram, electrocardiogram, oro-nasal airflow via a pressure transducer, and Epworth Sleepiness Scale will be done. Then both study group participants will receive their respective appliances. And after one month and three months of delivery of the appliance, all the parameters, i.e., AHI, oxygen saturation in blood, percentage of rapid eye movement, electroencephalogram, electrocardiogram, oro-nasal airflow via a pressure transducer, and Epworth Sleepiness Scale will be re-evaluated and compared with the baseline measurements. Descriptive and analytical statistics will be done. SPSS (Statistical Package for Social Sciences) Version 20.1 will be used as statistical software. The statistical significance between the two groups after one month and three months will be evaluated atp&lt; 0.05.DiscussionWe expect, customized maxillary oral appliance to be more efficient in managing moderate OSA, in comparison with MAD. If the hypothesis of the present study is confirmed, then this customized maxillary appliance will be quoted as a “gold standard” for managing moderate OSA.Trial registrationCTRI/2020/07/026936Registered 31 July 2020.</jats:sec