| CTRI Number |
CTRI/2024/10/075423 [Registered on: 17/10/2024] Trial Registered Prospectively |
| Last Modified On: |
16/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to compare the effect of hard versus soft occlusal splint for symptomatic management of temporomandibular joint disorders. |
|
Scientific Title of Study
|
THE EFFECTIVENESS OF SOFT AND HARD SPLINTS IN THE SYMPTOMATIC MANAGEMENT OF TEMPOROMANDIBULAR JOINT DISORDERS: A COMPARATIVE STUDY |
| 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 Bharti Vyas |
| Designation |
Postgraduate Resident- Orthodontics |
| Affiliation |
Government College of Dentistry, Indore |
| Address |
Dept no. 11, Orthodontics and dentofacial orthopedics, Government college of dentistry, 1, Sardar Patel marg, Indore, Madhya Pradesh
1, Sardar Patel Marg, Opp. MY Hospital , Indore, Madhya Pradesh, India
Indore
MADHYA PRADESH
452001
India |
| Phone |
07509728778 |
| Fax |
|
| Email |
bhartivyas21697@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sandhya Jain |
| Designation |
Professor & Head- Orthodontics |
| Affiliation |
Government College of Dentistry, Indore |
| Address |
Dept NO. 11- orthodontics and dentofacial orthopedics, Government college of dentistry, 1, sardar patel marg, Indore, Madhya Pradesh
1, Sardar Patel Marg, Opp. MY Hospital , Indore
Indore
MADHYA PRADESH
452001
India |
| Phone |
9425045455 |
| Fax |
|
| Email |
researchorthodontics@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharti Vyas |
| Designation |
Postgraduate Resident- Orthodontics |
| Affiliation |
Government College of Dentistry, Indore |
| Address |
Dept no. 11- Orthodontics and dentofacial orthopedics, Government college of dentistry, 1,saradr patel marg, Indore, Madhya Pradesh
1, Sardar Patel Marg, Opp. MY Hospital , Indore
Indore
MADHYA PRADESH
452001
India |
| Phone |
07509728778 |
| Fax |
|
| Email |
bhartivyas21697@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government College of dentistry,Indore
Dept No. 11, 1- sardar patel marg,opp. MY hospital, Indore, Madhya pradesh, India, 452001. |
|
|
Primary Sponsor
|
| Name |
Dr Bharti Vyas |
| Address |
1, Sardar patel marg, Opp. MY Hospital, Indore, Madhya Pradesh, Indore, 452001 |
| Type of Sponsor |
Other [Individual] |
|
|
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 Bharti Vyas |
Government college of dentistry |
Dept No. 11, Orthodontics and dentofacial orthopedics
Indore
MADHYA PRADESH |
07509728778
bhartivyas21697@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Govt. College of Dentistry,Indore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M248||Other specific joint derangements,not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hard Occlusal Splint |
For management of temporomandibular disorders, symptomatic relief indicated by pain, mouth opening, muscle tenderness and clicking using hard occlusal splint for duration of 4 months. |
| Comparator Agent |
Soft Occlusal splint |
For management of temporomandibular disorders, symptomatic relief inidcated by pain, mouth opening, muscle tenderness and clicking using soft occlusal splint for duration of 4 months. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis of Myofascial pain ( Tenderness of masticatory muscles, deviated or restricted mandibular movement and myofascial pain duration of atleast 3 months) and Internal derangement of Temporomandibular joint with Reciprocal clicking ( Anterior disc displacement with reduction, negative locked jaw, history of TMJ noise)
|
|
| ExclusionCriteria |
| Details |
1.Previous history of treatment for TMD.
2.Patient diagnosed with osteoarthrtis or osteoarthrosis of TMJ.
3.Patients with previous history of treatment for TMDs.
4.Patient diagnosed with disc displacement without reduction.
5.Patient diagnosed with any other causes of Trismus.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
a) Pain
b) Maximum mouth opening
c) TMJ clicking
d) Muscle tenderness
|
4 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Maximum mouth opening
TMJ clicking
Muscle tenderness
|
4 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/11/2024 |
| 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="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
|
Study aims at comparative evaluation of effectiveness of hard and soft occlusal splint for the symptomatic relief of temporomandibular joint disorders. The comparison is drawn between the hard and soft splint effects in terms of relief in pain, mouth opening, muscle tenderness and clicking after wearing the occlusal splint for minimum of 22 hours for duration of 4 months with measurement of data every 1 month following the delivery of the appliance. |