| CTRI Number |
CTRI/2024/04/066361 [Registered on: 26/04/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparison between single soft splint vs double soft splint for temporomandibular disorder patients |
|
Scientific Title of Study
|
Comparative assessment of effectiveness of uni-arch soft splint and bi-arch soft splint in patients with temporomandibular disorders using helkimo index analysis. |
| 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 AshwinthanM |
| Designation |
PG student |
| Affiliation |
tamil nadu MGR University |
| Address |
Chettinad dental college kelambakkam, Oral medicine and radiology department, diviion E Block, room number 1
Chettinad dental college kelambakkam, Oral medicine and radiology department, diviion E Block, room number 1
pin code 603103
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
27485660 |
| Fax |
- |
| Email |
murugan3592@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Christeffi mabel |
| Designation |
Professor and HOD |
| Affiliation |
tamil nadu MGR University |
| Address |
Chettinad dental college kelambakkam, Oral medicine and radiology department, diviion E Block, room number 1
Chettinad dental college kelambakkam, Oral medicine and radiology department, diviion E Block, room number 1
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
27487550 |
| Fax |
- |
| Email |
christeffimabelr@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwinthan.M |
| Designation |
Postgraduate |
| Affiliation |
tamil nadu MGR University |
| Address |
Chettinad dental college kelambakkam, Oral medicine and radiology department, diviion E Block, room number 1
Chennai
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
27487330 |
| Fax |
- |
| Email |
herosup34@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad dental college and research institute, Kelambakkam, Tamil N adu 603103 |
|
|
Primary Sponsor
|
| Name |
Ashwinthan M |
| Address |
Senganmal, kelambakkam, kancheepuram district, tamilnadu, 603103 |
| 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 |
| Dr Ashwinthan M |
Chettinad dental hospital and research institute |
room number 1 department of oral medicine and radiology and division 1
Kancheepuram
TAMIL NADU |
04427387550
-
herosup34@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chettinad Academy of Research and Education (Deemed to be University)Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bi-arch softsplint |
2mm thickness of maxillary occlusal soft splint and 2mm thickness of mandibular soft splint given to 24 participants with temporomandibular disorders for 90 days duration. |
| Intervention |
Uni-arch softsplint |
Occlusal soft splint of 2mm thickness given in mandibular arch for 90 days to 24 particpants with temporomandibular disorders. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are clinically diagnosed with temporomandibular disorder.
Patients those who are willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
Patients with only clicking sounds and without pain.
Patients who are allergic to muscle relaxants medicine.
Patients with severe trauma with tmj fracture.
Patients who are pregnant or lactating.
Patients who are above age group 50.
Patients who are below age group 18.
Patients who are not willing to participate in the study.
Patients who have gastritis, peptic or duodenal ulcers.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| No clinical dysfunction of and no symptoms after splint therapy for temporomandibular disorder patients |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Returning jaw position and reducing excess jaw load |
1 month |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/05/2024 |
| 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="3"
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
|
Clinical trial has been performed to evaluate the effectiveness of soft splint for patients who are suffering from temporomandibular disorders.
Two Group were chosen GROUP A and GROUP B
In GROUP A, uni arch splint or single arch splint is given to tmd patients
and recovery is evaluated using Helkimo index
In GROUPB, bi arch splint or double arch splint is given to tmd patients
and recovery is evaluated using same Helkimo index
The study duration will be conducted for three months. |