| CTRI Number |
CTRI/2024/05/066700 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
29/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Full Mouth Rehabilitation and it’s affect on the TemporoMandibular Joint Function |
|
Scientific Title of Study
|
Evaluate the Disocclusion Timing and Temporomandibular Joint Function in Full Mouth Rehabilitated Cases Established with Different Vertical Dimension |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rahul Koppaka |
| Designation |
Post graduate student |
| Affiliation |
Saveetha Dental College |
| Address |
Clini 24, Department of Prosthodontics
Saveetha dental college
Thiruvallur
TAMIL NADU
600056
India |
| Phone |
8208053691 |
| Fax |
|
| Email |
152109003.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amruta Shenoy |
| Designation |
Senior lecturer |
| Affiliation |
Saveetha Dental College |
| Address |
Department of Prosthodontics
Saveetha dental college
Thiruvallur
TAMIL NADU
6000077
India |
| Phone |
9819122808 |
| Fax |
|
| Email |
adshenoy197@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amruta Shenoy |
| Designation |
Senior lecturer |
| Affiliation |
Saveetha Dental College |
| Address |
Department of Prosthodontics
Saveetha dental college
Thiruvallur
TAMIL NADU
6000077
India |
| Phone |
9819122808 |
| Fax |
|
| Email |
adshenoy197@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College, Mount Poonamallee High Road, Velapanchavadi, Chennai-77 |
|
|
Primary Sponsor
|
| Name |
Saveetha Dental College |
| Address |
162, Poonamallee High Road, Velappanchavadi, Chennai- 600077 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rahul Koppaka |
Saveetha Dental College and Hospital |
Clinic 24, Department of Prosthodontics, 162, Poonamallee High Road, Vellapanchavadi, Chennai- 600056
Chennai
TAMIL NADU |
8652355931
152109003.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College- Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Full Mouth Rehabilitation |
Patients reuqiring a Tooth supported Full mouth rehabilitation
Or
Tooth Implant Supported rehabilitation
Approximate time for treatment : 3-4 months |
| Comparator Agent |
Pre operative |
All values are taken before start of treatment to use as a comparative value. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Tooth supported rehabilitation
Implant and tooth supported rehabilitation |
|
| ExclusionCriteria |
| Details |
Removable prosthesis
Full implant supported prosthesis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TemporoMandibular Joint Function |
0, 1 month, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient Satisfaction and Quality of Life |
0, 1 month, 3 months, 6 months |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/05/2024 |
| 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="0"
Months="6"
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
|
Malocclusion plays a crucial role in the development of temporomandibular joint (TMJ) diseases, constituting a substantial portion, ranging from 34 to 87%, in the structure of this pathology. Most experts pos that anomalies in teeth alignment are influenced to a lesser extent by the morphological characteristics of joint elements and more significantly by changes in intra-articular relationships. Alterations in the articular surfaces and TMJ capsules due to occlusion-related changes typically exacerbate age-related changes, creating anatomical conditions that contribute to dysfunction |