| CTRI Number |
CTRI/2020/07/026716 [Registered on: 21/07/2020] Trial Registered Prospectively |
| Last Modified On: |
20/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [stabilization splints] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluating the effect of different thicknesses of intraoral splint in treatment of patient with temporomandibular disorder using joint vibration analysis as diagnostic tool . |
|
Scientific Title of Study
|
‘Comparative Evaluation of Temporomandibular joint Function And Treatment Response Using Joint Vibration Analysis In Patients Exhibiting Disc Displacement With Reduction, Treated With Three Variable Thickness Of Stabilization Splints : An In- Vivo Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| - |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrJyoti Sharma |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
VSPM DENTAL COLLEGE AND RESEARCH CENTRE |
| Address |
VSPM DENTAL COLLEGE AND RESEARCH CENTER,DIGDOH HILLS ,HINGNA NAGPUR .440019
VSPM DENTAL COLLEGE AND RESEARCH CENTER,DIGDOH HILLS ,HINGNA NAGPUR .440019
Nagpur
MAHARASHTRA
440027
India |
| Phone |
9503093341 |
| Fax |
|
| Email |
jsharma0174@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrJyoti Sharma |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
VSPM DENTAL COLLEGE AND RESEARCH CENTRE |
| Address |
Department of Prosthodontic and Crown Bridge and Implantology.
VSPM DENTAL COLLEGE AND RESEARCH CENTER,DIGDOH HILLS ,HINGNA NAGPUR .
Department of Prosthodontic and Crown Bridge and Implantology.
VSPM DENTAL COLLEGE AND RESEARCH CENTER,DIGDOH HILLS ,HINGNA NAGPUR .440019
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9503093341 |
| Fax |
|
| Email |
jsharma0174@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RAJLAKSHMI BANERJEE |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
VSPM DENTAL COLLEGE AND RESEARCH CENTRE |
| Address |
Department of PROSTHODONTICS CROWN BRIDGE AND IMPLANTOLOGY, VSPM Dental
College and Research Centre Digdoh Hills, Hingna road Nagpur
Department of PROSTHODONTICS CROWN BRIDGE AND IMPLANTOLOGY,
VSPM DENTAL COLLEGE AND RESEARCH CENTER,DIGDOH HILLS ,HINGNA NAGPUR .440019
Nagpur
MAHARASHTRA
440019
India |
| Phone |
|
| Fax |
|
| Email |
drrajlakshmi1@gmail.com |
|
|
Source of Monetary or Material Support
|
| VSPM DENTAL COLLEGE AND RESEARCH CENTER NAGPUR MAHARASHTRA |
|
|
Primary Sponsor
|
| Name |
NONE |
| Address |
NONE |
| 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 Jyoti Sharma |
VSPM DENTAL COLLEGE AND RESEARCH CENTRE NAGPUR |
Department of Prosthodontics,Crown Bridge Dentistry and Implantology, VSPM Dental
College and Research Centre Digdoh Hills, Hingna road Nagpur440019
India
Nagpur
MAHARASHTRA |
9503093341
jsharma0174@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VSPM Dental College and Research Centre Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
INDIVIDUALS BETWEEN AGE 18-55 YEARS (MALE AND FEMALES) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NONE |
| Intervention |
stabilization splints |
Three different thicknesses of stabilization splint given to 30 individuals with temporomandibular joint disorders.
Group A - 3mm thickness splint (10 patients )
Group B - 4mm thickness splint (10 patients )
Group C - 5mm thickness splint (10 patients )
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient with Disc displacement with reduction.
2.Clicking or pain present.
3.Reduced and/or deviated mouth opening and any other symptoms using RDC-TMD criteria.12
4.Patients were willing to be a part of the study.
|
|
| ExclusionCriteria |
| Details |
1.Asymptomatic patients.
2.Patient with Disc displacement without reduction.
3.Medically compromised patients.
4.Patients not willing to take part in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of different thickness of stabilization splint (3mm,4mm,5mm)on Temporomandibular joint. |
Effect of different thickness of stabilization splints at interval of 3 weeks,5 weeks and 7 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Variation In Joint Vibration Analysis |
Preoprative -0Weeks
Postoprative - 7 Weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1 |
|
Date of First Enrollment (India)
|
25/07/2020 |
| 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="1"
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)?
|
|
Brief Summary
|
Temporomandibular joint disorders (TMD) is a cluster of coexisting conditions and clinical problems with multifactorial etiology with many factors contributing to the progression and management of the disease. The use of splints is presently considered the most common treatment modality. The study will be conducted to investigate the effect of variable thicknesses of stabilization splint on the Temporomandibular joint in patients with disc displacement with reduction using joint vibration analysis as a diagnostic tool.
A total of 30 subjects with the age range of 18-55 years including both male and female visiting the Department of Prosthodontics at VSPM Dental College and Research Centre Nagpur will be recruited. The study population will be divided into 3 groups: 1. Group A – 10 patients, both males and females given stabilization splint of thickness 3 mm 2. Group B – 10 patients, both males and females given stabilization splint of thickness 4mm 3. Group C – 10 patients, both males and females given stabilization splint of thickness 5mm Written informed consent will be taken from the patients prior.
Though there have been reported studies of comparison between different types of splints, comparative evaluation of the treatment response using the varying thickness of splints using JVA has not been done before which brings the need for the study to be conducted. The result will be obtained by the improvement seen in temporomandibular joint disorder.
|