FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/071578 [Registered on: 30/07/2024] Trial Registered Prospectively
Last Modified On: 29/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Comparison of efficacy of 2 oral appliances for relieving snoring 
Scientific Title of Study   Comparison of the efficacy and comfort of oral appliances by change in vertical dimension for symptomatic relief in individuals with non-apneic snoring and three-dimensional evaluation of the changes created in the upper pharyngeal airway using Cone-Beam Computed Tomography - A randomized controlled crossover trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aayushi Chauhan 
Designation  PG student 
Affiliation  Government dental college and hospital Aurangabad 
Address  Room 238, 2nd floor, Department of Orthodontics and dentofacial orthopedics, GDC Aurangabad, Ghati campus, Navkhanda

Aurangabad
MAHARASHTRA
431001
India 
Phone  8390411166  
Fax    
Email  aayushichauhan95@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rakesh Mohode 
Designation  Associate Professor  
Affiliation  Government dental college and hospital Aurangabad 
Address  Room 238, 2nd Floor, Department of Orthodontics and Dentofacial Orthopedics, Ghati Campus, Aurangabad

Aurangabad
MAHARASHTRA
431001
India 
Phone  9869103113  
Fax    
Email  rakeshmohode@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rakesh Mohode 
Designation  Associate Professor  
Affiliation  Government dental college and hospital Aurangabad 
Address  Room 238, 2nd Floor, Department of Orthodontics and Dentofacial Orthopedics, Ghati Campus, Aurangabad

Aurangabad
MAHARASHTRA
431001
India 
Phone  9869103113  
Fax    
Email  rakeshmohode@gmail.com  
 
Source of Monetary or Material Support  
Government Dental College and Hospital, Navkhanda, Ghati campus, Aurangabad, Maharashtra, India 431001 
 
Primary Sponsor  
Name  Aayushi Chauhan 
Address  Government Dental college and hospital, Navkhanda, Ghati Campus, Aurangabad, Maharashtra India 431001 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Aayushi Chauhan  Government Dental College and Hosptial Aurangabad  Room 238, 2nd Floor, Department of Orthodontics and Dentofacial Orthopedics, Ghati Campus, Aurangabad
Aurangabad
MAHARASHTRA 
8390411166

aayushichauhan95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Government Dental College Aurangabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Snorer 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Mandibular Advancement Appliance 1  Twin block appliance with increased vertical opening as compared to Mandibular Advancement Appliance 2 
Intervention  Mandibular Advancement Appliance 2 (with reduced vertical dimension)  Patients who only snore or have a mild OSA are less likely to use the machine since they are not as sleepy and would not wear something as invasive. A possible nonsurgical treatment modality consists of intraoral appliances (IOAs) that advance the mandible, has been found to reduce breathing disturbances and snoring. However, due to inherent flaws in the appliance design (which requires increased vertical opening to function properly) the patients experience pain in the jaws and disturbances in the occlusion with such appliances. Therefore, to make the intraoral appliance comfortable, effective, easy to use and economical a new appliance was designed which would reduce vertical opening of the appliance.  
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Snorer
No missing teeth 
 
ExclusionCriteria 
Details  1. Periodontal disease
2. Edentulous
3. Nasal congestion / obstruction
4. Patient on sedatives
5. Epileptic or mentally challenged patients
6. Temporomandibular joint pain/clicking
7. Patients with any neuromuscular disorder
8. Obesity 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Epworth sleepiness scale score,
Decibel recording,
Volumetric airway measurement 
Ewporth Sleepiness scale score to be assessed after 2 weeks
Decibel recordings will be taken daily for 2 weeks after appliance delivery
Volumetric airway measurement will be done using cbct on the day of appliance delivery 
 
Secondary Outcome  
Outcome  TimePoints 
Patient will be asked if appliance was comfortable for wear in a YES NO format  after 2 weeks of appliance wear 
 
Target Sample Size   Total Sample Size="21"
Sample Size from India="21" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
A literature search indicates that since 1985 approximately 150 articles that describe various oral devices used in the treatment of sleep disorders have been published. The majority of these studies represent case series or case reports and a much smaller number are randomized controlled trials. It is generally accepted that treatment of OSA with oral appliances is a viable option for some patients with varying degrees of short- and long-term improvement and side effects. Oral appliance treatment includes, in order of decreasing usage, adjustable and nonadjustable mandibular posturing devices, anterior tongue positioners, and soft palate or uvula lifting devices. An appliance that advances the tongue, or tongue and mandible together with adjacent soft tissue, increases the posterior airway space, increases the activity of the genioglossal and lateral pterygoid muscles. It is not yet possible to predict the most advantageous appliance type for a particular patient. There are conflicting data regarding the effect of the degree of bite opening (vertical dimension of opening [VDO]) induced by oral appliances on treatment outcome. Although some studies have shown that appliances that promote an increased VDO are effective, physiologic evidence suggests that the VDO should be kept to a minimum to optimize treatment outcome. In this study, the efficacy of the of an oral appliance with minimum VDO will be tested against an appliance that increases VDO (such as twin block) based on the Epworth Sleepiness scale, Decibel readings, overall comfort of appliance for the patient, any potential side effects of either appliance. Furthermore, Computed tomographs will be taken to see the effect of the two appliances on the upper airway space of the patient with non-apnoeic snoring.
 
Close