| CTRI Number |
CTRI/2020/08/027024 [Registered on: 07/08/2020] Trial Registered Prospectively |
| Last Modified On: |
28/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study for usefulness of novel method of preparing oral splints with and without supportive treatment of physiotherapy in treatment of Temporo-mandibular Joint Disorders |
|
Scientific Title of Study
|
Comparative Evaluation of the Efficacy of TMD splint constructed using AD2 articulator, with and without Physiotherapy, in the management of Mild to Moderate TMD cases with Conventional TMD Splint therapy- A Randomized Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Eshita Jaiswal |
| Designation |
Assistant Professor |
| Affiliation |
Sharad Pawar Dental College and Hospital |
| Address |
Dept of Orthodontics,
Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Medical Sciences, Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9823605717 |
| Fax |
|
| Email |
eshita7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunita Shrivastav |
| Designation |
Professor and Guide |
| Affiliation |
Sharad Pawar Dental College and Hospital |
| Address |
Dept of Orthodontics,
Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Medical Sciences, Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7743900590 |
| Fax |
|
| Email |
sunitashrivastav92@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunita Shrivastav |
| Designation |
Professor and Guide |
| Affiliation |
Sharad Pawar Dental College and Hospital |
| Address |
Dept of Orthodontics,
Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Medical Sciences, Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7743900590 |
| Fax |
|
| Email |
sunitashrivastav92@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthodontics and Dentofacial Orthopedics,
Sharad Pawar Dental College and Hospital,
Datta Meghe Institute Of Medical Sciences, Sawangi Meghe, Wardha- 442001 |
|
|
Primary Sponsor
|
| Name |
Dr Eshita Jaiswal |
| Address |
Dept of Orthodontics,
Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Medical Sciences, Sawangi Meghe Wardha |
| 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 Sunita Shrivastav |
Sharad Pawar Dental College |
Dept of Orthodontics,
Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Medical Sciences, Sawangi Meghe Wardha
Wardha
MAHARASHTRA |
7743900590
sunitashrivastav92@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 |
| Patients |
(1) ICD-10 Condition: M278||Other specified diseases of jaws, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventionally fabricated TMD splints |
Conventional Stabilising TMD splints
10-12 hours wear during evening and night time for 6 weeks and Sequencial Withdrawl upto 12 weeks |
| Intervention |
TMD Splint fabricated using AD2 articulator with physiotherapy |
TMD Splint fabricated using AD2 articulator
10-12 hrs during evening and night for 6 weeks and Sequencial Withdrawl upto 12 weeks
Physiotherapy- 6 weeks |
| Intervention |
TMD Splint fabricated using AD2 articulator without physiotherapy |
TMD Splint fabricated using AD2 articulator without physiotherapy
10- 12 hours per day during evening and night
6 weeks
Sequencial Withdrawl upto 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients with mild to moderate TMDs.
|
|
| ExclusionCriteria |
| Details |
Patients having TMDs of severe grade.
Patients who underwent surgery for TMDs
Patients who underwent surgery for condylar morphology modification
Patients with Condylar dysplasia
Patients with faulty Dental Restorations
patients with Trauma to Temporomandibular Joint
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Decrease in TMD severity and
Associated Pain
|
3 weeks
6 weeks
12 weeks
18 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time Duration
Mouth Opening
Quality of Life |
3 weeks
6 weeks
12 weeks
18 weeks |
|
|
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 |
|
Date of First Enrollment (India)
|
25/10/2020 |
| 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="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, parallel-group, active control outcome assessor-blinded, comparing the efficacy of TMD (Temporomandibular Disorders) Splint fabricated using the AD2 Articulator system with and without physiotherapy in the management of TMDs with Conventional Splint therapy in 48 mild to moderate TMD cases. The primary outcomes will be a decrease in the severity of TMDs evaluated using the Helkimo index and Treatment Duration Control Index and Pain evaluated using the Chronic Pain Grading Score Index. The secondary outcomes will be Treatment duration, Mouth opening measured using Digital Vernier Calliper and Quality of Life evaluated using WHO Oral Health Impact Profile-14 questionnaire. |