| 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
|
|
|
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
|
|
|
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. |