| CTRI Number |
CTRI/2024/02/063310 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
22/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Best Splint for Temporomandibular Joint Pain |
|
Scientific Title of Study
|
Comparative effectiveness of Soft Splint, Centric Stabilization Splint, and
Hydrostatic Splint in patients exhibiting Temporomandibular disorders- A
Randomized control trial |
| 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 Abhishek Kumar Gupta |
| Designation |
Assistant Professor |
| Affiliation |
ESIC Dental College and Hospital |
| Address |
Department of Prosthodontics and Crown & Bridge,
ESIC Dental College & Hospital, Sector-15, Rohini, New Delhi-110085
Department of Prosthodontics and Crown & Bridge,
ESIC Dental College & Hospital, Sector-15, Rohini, New Delhi-110085
North
DELHI
110089
India |
| Phone |
8004001392 |
| Fax |
|
| Email |
drabhishek.gupta1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Bhawana Tiwari |
| Designation |
Director Prof and Head |
| Affiliation |
ESIC DENTAL COLLEGE AND HOSPITAL |
| Address |
Department of Prosthodontics and Crown & Bridge,
ESIC Dental College & Hospital, Sector-15, Rohini, New Delhi-110085
Department of Prosthodontics and Crown & Bridge,
ESIC Dental College & Hospital, Sector-15, Rohini, New Delhi-110085
North
DELHI
110089
India |
| Phone |
9642826010 |
| Fax |
|
| Email |
bhawanat1812@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Komal Maheshwari |
| Designation |
Professor |
| Affiliation |
ESIC DENTAL COLLEGE AND HOSPITAL |
| Address |
Department of Prosthodontics and Crown & Bridge,
ESIC Dental College & Hospital, Sector-15, Rohini, New Delhi-110085
Department of Prosthodontics and Crown & Bridge,
ESIC Dental College & Hospital, Sector-15, Rohini, New Delhi-110085
North
DELHI
110089
India |
| Phone |
9811586215 |
| Fax |
|
| Email |
komalladha@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Prosthodontics and Crown & Bridge,
ESIC Dental College & Hospital, Sector-15, Rohini, New Delhi-110085
ESIC dental college and hospital, New Delhi -110089 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Abhishek Kumar Gupta |
ESIC Dental College & Hospital |
Department of Prosthodontics and Crown & Bridge
North
DELHI |
8004001392
drabhishek.gupta1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ESIC Institutional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Centric Stabilization Splint |
Centric Stabilization Splint is given to the patients having TMD RDC/TMD Axis 1.
The duration of the splint wearing is 3 months. Pre and Post intervention would be analysed using Helminko dysfunction index. |
| Intervention |
Hydrostatic Splint |
Hydrostatic Splint will be given to the patients having TMD RDC/TMD Axis 1. The duration of the splint wearing is 3 months. Pre and Post intervention would be analysed using Helminko dysfunction index. |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Soft Splint |
Soft Splint is given to the patients having TMD RDC/TMD Axis 1.
The duration of the splint wearing is 3 months. Pre and Post intervention would be analysed using Helminko dysfunction index. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient’s age ranging from 18 years to 45 years (both included) were included in our study.
2. Patients were recruited irrespective of sex, religion, caste or socioeconomic status.
3. RDC/TMD classification among Axis 1 were selected.
4. Fully dentate or at least had sufficient occlusal stops, no more than two posterior teeth missing in each quadrant (excluding third molars) were selected.
|
|
| ExclusionCriteria |
| Details |
1. Completely edentulous patients or patients with no posterior occlusal stops were excluded from the study.
2. Patents having reduced mouth opening were excluded from the study.
3. Patients who had undergone previous treatment with occlusal appliances were also excluded from the study.
4. Patients undergoing Orthodontic treatment were excluded from the study.
5. Patients with pain because of systemic disease (eg; rheumatoid arthritis, etc) were also excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in mandibular mobility, TMJ Function.
|
At 1st week ,1st month, 3nd month and 6th month to review. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Better life quality and better mastication ability |
At the end of 3 months |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/03/2024 |
| Date of Study Completion (India) |
30/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Occlusal splint treatment is commonly used to treat patients with temporomandibular disorders (TMDs), with efficacy ranging between 70% and 90%. The aetiology of TMD is multifaceted, with factors such as predisposing, initiating, and perpetuating factors. Hard, soft, and hydrostatic splints are used to relieve muscular soreness in patients with TMD. Electromyography (EMG) is used to assess muscle activity and evaluate the effectiveness of splint therapy on the masticatory muscle complex. This study aims to compare the effectiveness of hard, soft, and hydrostatic splints in treating patients with TMD using more parameters and EMG. The study will be a double-blinded, randomized controlled clinical trial on 45 patients with TMD pain/clicking/other joint symptoms. The sample size will be based on the Research Diagnostic Criteria for Temporo-Mandibular Disorders (RDC/TMD).
The study aims to evaluate the effectiveness of a new approach to managing temporomandibular disorders (TMDs) using a hydrostatic splint. The study uses a Bio EMG Machine, BioPAK software, a computer, alginate impression material, dental stone, interocclusal record making material, face bow, semi- adjustable articulator, clear heat cure acrylic resin, and soft splint sheet. The splint is made using a combination of a centric stabilization splint, a soft splint, and a hydrostatic splint. The splint is worn for 6 months and the parameters for TMJ function are reviewed at regular follow-up appointments. The study’s statistical evaluation uses the Tukey test and Kruskal-Wallis H-test.
The study aims to assess mandibular mobility, TMJ dysfunction, and evaluate the Masticatory Muscles EMG before and after treatment of splint therapy in patients with Temporomandibular Disorders (TMD). Participants will wear splints according to instructions, and baseline data will be collected. The study is voluntary, and participants may benefit from improving TMD symptoms and reducing facial masticatory muscle pain. No financial reimbursement is provided, and participants can withdraw at any time. |