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CTRI Number  CTRI/2025/09/093960 [Registered on: 01/09/2025] Trial Registered Prospectively
Last Modified On: 30/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Implant supported complete denture as a treatment appliance for obstructive sleep apnea patient 
Scientific Title of Study   Effect of Mandibular Implant Supported Overdenture on Genioglossus Muscle Activity and Airway Space Dimension among Completely Edentulous Patients Diagnosed with Mild to Moderate Obstructive Sleep Apnea  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Maheshwari T 
Designation  Third year postgraduate student 
Affiliation  Sri Ramachandra Dental College & Hospital 
Address  Sri Ramachandra Dental College & Hospital, Department of Prosthodontics and crown & bridge, Room no: 8, 1, Mount Poonamallee Rd, Sri Ramachandra Nagar, Iyyappanthangal, Chennai

Chennai
TAMIL NADU
600116
India 
Phone  6381099063  
Fax    
Email  mahethirupathi08@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr M Uma maheswari 
Designation  Associate Proffessor 
Affiliation  Sri Ramachandra Dental College & Hospital 
Address  Sri Ramachandra Dental College & Hospital, Department of prosthodontics and crown & bridge, Room no 8, 1, Mount Poonamallee Rd, Sri Ramachandra Nagar, Iyyappanthangal, Chennai, Tamil Nadu 600116

Chennai
TAMIL NADU
600116
India 
Phone  9940663913  
Fax    
Email  umamaheswari.m@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr M Uma maheswari 
Designation  Associate Proffessor 
Affiliation  Sri Ramachandra Dental College & Hospital 
Address  Sri Ramachandra Dental College & Hospital, Departemnt of prosthodontics and crown & bridge, Room no 8, 1, Mount Poonamallee Rd, Sri Ramachandra Nagar, Iyyappanthangal, Chennai, Tamil Nadu 600116


TAMIL NADU
600116
India 
Phone  9940663913  
Fax    
Email  umamaheswari.m@sriramachandra.edu.in  
 
Source of Monetary or Material Support  
Self funded. NAME OF THE INSTITUTE- Sri Ramachandra Dental College & Hospital, Departemnt of prosthodontics and crown & bridge, 1, Mount Poonamallee Rd, Sri Ramachandra Nagar, Iyyappanthangal, Chennai, Tamil Nadu 600116 
 
Primary Sponsor  
Name  Dr Maheswari 
Address  Sri Ramachandra dental college and hospital,1, Mount Poonamallee Rd, Sri Ramachandra Nagar, Iyyappanthangal, Chennai, Tamil Nadu 600116 
Type of Sponsor  Other [self funded] 
 
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 
Dr Maheshwari  Sri Ramachandra Dental college & Hospital  Sri Ramachandra Dental College & Hospital, Department of prosthodontics and crown & bridge, room no 8, 1, Mount Poonamallee Rd, Sri Ramachandra Nagar, Iyyappanthangal, Chennai, Tamil Nadu 600116
Chennai
TAMIL NADU 
06381099063

mahethirupathi08@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  COMPLETELY EDENTULOUS PATIENTS WITH OSA 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Completely edentulous maxillary and mandibular ridges
2.Age group of 50-70 years
3.Adequate bone width and length for implant placement
4.Patient with Mild to moderate risk of sleep apnoea will be screened using STOP-BANG questionnaire
 
 
ExclusionCriteria 
Details  1. Systemic disease like uncontrolled diabetes, hypertension, thyroid disorders, cardiovascular disorders, blood dyscrasias.
2. Patient with history of metabolic syndrome and musculoskeletal disorders
3. Patient with past history of oral surgery which involves tongue and palate
4. Severe ridge resorption and flabby ridges
5. Severe sleep apnea
6.Absolute and relative contraindication for rehabilitation with implant
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To Assess Genioglossus Muscle Activity, Posterior Airway Space Dimension  0 day, 8th week, 3rd month, 6th month 
 
Secondary Outcome  
Outcome  TimePoints 
To Assess Salivary Melatonin Level  0 day, 8th week, 3rd month, 6th month 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
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)   15/09/2025 
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="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Complete edentulism influences the postural position of the mandible, tongue posture muscle tone, and vertical dimension. These structural alterations reduce the upper airway space dimension. Reduction in upper airway dimension eventually increases the apnoeic episodes in patients with obstructive sleep apnea (OSA) and leads to sleep disturbances. Complete denture prosthesis, for edentulous patients has been found to improve the airway space dimensions by increasing the lost vertical dimension. The upper airway space patency is also determined by the position of the mandible, tongue size and position and their coherent muscle activity. Amongst the determinants, the peri-pharyngeal muscle activity has more influence on maintaining the airway space patency. Genioglossus, is the largest and most potent pharyngeal dilator muscle which causes protrusion and tongue depression thereby preventing the upper airway collapse. An implant-supported complete denture unlike a conventional complete denture prosthesis can restore the sensorimotor feedback by a reorganized pattern in the central nervous system. This sensory feedback is described as passive tactile sensation which improves the muscle activity. But there are no clinical studies which has evaluated the genioglossus muscle activity in patients wearing implant supported complete dentures and their association in maintaining the airway space among edentulous patients diagnosed with OSA. Airway space patency is crucial to reduce apnoeic episodes and improve the quality of sleep. The improvement in sleep quality has been subjectively evaluated among older edentulous population wearing implant supported prosthesis but the rationale behind the improvement in sleep quality has not been investigated and measured. Melatonin a hormone secreted by the pineal gland has been studied to improve sleep quality, duration and efficiency. Serum melatonin can be used for the assessment of quality of sleep but it is an invasive method and requires frequent sampling through intravenous catheter. Whereas salivary melatonin is a well-documented and non-invasive biomarker of sleep quality and its circadian rhythm. Hence, the present study aims to assess the effect of mandibular implant supported overdenture on genioglossus muscle activity, upper airway space dimension and salivary melatonin levels among completely edentulous patients diagnosed with mild to moderate OSA.

 
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