| CTRI Number |
CTRI/2018/04/013387 [Registered on: 20/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
18/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Checking the differences in the biting forces between healthy people and people having pain in the jaw joint |
|
Scientific Title of Study
|
“DIGITAL EVALUATION OF FUNCTIONAL OCCLUSAL PARAMETERS USING 3D OCCLUSAL ANALYSIS SYSTEM (TEK SCAN) AND THEIR ASSOCIATION WITH TEMPOROMANDIBULAR DISORDERS. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr THUMULA RESHMI |
| Designation |
Post graduate student |
| Affiliation |
VISHNU DENTAL COLLEGE BHIMAVARAM |
| Address |
Department Of Oral Medicine And Radiology
Room 1
Block 3
Vishnu Dental College
Vishnupur
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
7036192874 |
| Fax |
|
| Email |
reshi.thumula@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Jyothirmai |
| Designation |
Reader |
| Affiliation |
Vishnu Dental College |
| Address |
Department Of Oral Medicine And Radiology
Room 1
Block 3
Vishnu Dental College
Vishnupur
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9866432477 |
| Fax |
|
| Email |
jyothirmaik2006@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Jyothirmai |
| Designation |
Reader |
| Affiliation |
Vishnu Dental College |
| Address |
Department Of Oral Medicine And Radiology
Room 1
Block 3
Vishnu Dental College
Vishnupur
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9866432477 |
| Fax |
|
| Email |
jyothirmaik2006@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room 1, Block 3 Vishnu Dental College, Vishnupur,Bhimavaram. pin code 534202, Andhra pradesh. |
|
|
Primary Sponsor
|
| Name |
Dr Thumula Reshmi |
| Address |
Department of Oral Medicine and Radiology |
| 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 Thumula reshmi |
Vishnu dental college |
Department of Oral Medicine and Radiology
Room number 1
Block number 3
Vishnu dental college
Vishnupur
Bhimavaram
West Godavari
ANDHRA PRADESH |
7036192874
reshi.thumula@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical commitee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Temporomandibular disorder patients, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tek scan in diagnosis of Temporomandibular disorders |
Evaluation of occlusal disharmony using Tek scan for 15 minutes for one time and their association with Temporomandibular disorders patients. Scan is taken once |
| Comparator Agent |
Tek scan in normal healthy individuals |
evaluation of occlusion using Tek scan for 15 minutes for one time in normal healthy individuals.Scan is taken once |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Temporomandibular disorder Group
1. Temporomandibular joint sounds
(clicking or crepitation)
2. Temporomandibular jointlocking
episodes.
3. Limited mandibular opening.
4. Painful limitation of mandibular movements.
5. Tenderness to palpation of the Temporomandibular joint or of the masticatory muscles.
CONTROL GROUP : Age and gender matched patients without any signs of Temporomandibular disorders
|
|
| ExclusionCriteria |
| Details |
1. Patients with developmental anomalies of temporomandibular joint.
2. Patients with a history of fractures to temporomandibular joint.
3. Patients with systemic and/or localized maxillofacial disease.
4. Patients with ear and neural disorders.
5. Patients who are not willing to participate in the study
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of occlusion as an etiological factor in the onset of temporomandibular disorders |
Effect of occlusion as an etiological factor in the onset of temporomandibular disorders -15 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| impact of occlusal variations on the health and integrity of temporomandibular joint |
impact of occlusal variations on the health and integrity of temporomandibular joint -15 minutes |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "44"
Final Enrollment numbers achieved (India)="44" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
04/01/2016 |
| Date of Study Completion (India) |
14/07/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a comparitive observational study to assess the impact of occlusal disharmony in the onset of Temporomandibular disorders using three dimensional occlusal analysis system (Tek scan).A total of 44 subjects (19 males and 25 females) within the age range of 15 -65 years were included in the present study and subjects with presence of signs and symptoms of TMD according to research diagnostic criteria (RDC) were grouped into the TMD category and the subjects who were free from the signs and symptoms were included into the control group. A complete intraoral examination of hard tissues was done and the details regarding the type of occlusion i.e. whether the subject is having canine-guided or group function occlusion and type of occlusal interferences i.e. whether the subject is having on the balancing side or working side or during protrusive movements clinically and were also evaluated using articulating paper. Only the subjects having the occlusal interferences and clinical signs and symptoms were included in the study under TMD group. Imaging of TMJ was done according to the requirement to confirm TMD. Based on the clinical signs and symptoms and radiographic signs subjects were given an appropriate diagnosis according to RDC criteria. Various categories included were myofascial pain, disc displacement with reduction, disc displacement without reduction, subluxation of the condyles, TMJ arthritis. Occlusal evaluation was done for all subjects in study and control groups using T-scan (Teck scan) VIII under 3 parameters i.e. occlusion time, disocclusion time in 3 excursive movements and percentage difference in the distribution of forces in between the right and the left halves of the arches and comparisons were made between two groups.Data analysis depicted that occlusal parameters like occlusion time, disocclusion time in right, left and protrusive movements were significantly high for the subjects in the TMD group than the control group.
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