| 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
|
|
|
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
|
|
|
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. |