| CTRI Number |
CTRI/2025/06/089180 [Registered on: 19/06/2025] Trial Registered Prospectively |
| Last Modified On: |
17/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Understanding the Jaw Joint in Asymmetrical Faces: With or Without Jaw Pain |
|
Scientific Title of Study
|
Morphological and positional assessment of condyle in facial asymmetry patients with or without temporomandibular disorders: A cbct 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 |
DrDesu Harshini |
| Designation |
Post graduate |
| Affiliation |
GSL dental college and hospital |
| Address |
department of orthodontics and dentofacial orthopedics, room no 9, GSL dental college and hospital, Lakshmipuram, Rajahmundry, Andhra pradesh. 533296
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
9182263613 |
| Fax |
|
| Email |
drdesuharshini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrGhanta Sunil |
| Designation |
Professor |
| Affiliation |
GSL dental college and hospital |
| Address |
department of orthodontics and dentofacial orthopedics, room no 9, GSL dental college and hospital, Lakshmipuram, Rajahmundry, Andhra pradesh. 533296.
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
9849551234 |
| Fax |
|
| Email |
sunildrghanta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrGhanta Sunil |
| Designation |
Professor |
| Affiliation |
GSL dental college and hospital |
| Address |
department of orthodontics and dentofacial orthopedics, room no 9, GSL dental college and hospital, Lakshmipuram, Rajahmundry, Andhra pradesh. 533296.
ANDHRA PRADESH
533296
India |
| Phone |
9849551234 |
| Fax |
|
| Email |
sunildrghanta@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Desu Harshini |
| Address |
department of orthodontics and dentofacial orthopedics, room no 9, GSL dental college and hospital, Lakshmipuram, Rajahmundry, Andhra pradesh. 533296 |
| 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 |
| DrDesu Harshini |
GSL dental college and hospital |
department of orthodontics and dentofacial orthopedics, room no 9, GSL dental college and hospital, Lakshmipuram, Rajahmundry, Andhra pradesh. 533296
East Godavari
ANDHRA PRADESH |
09182263613
drdesuharshini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GSL dental college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Facial Asymmetry |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
3 groups - To assess positional and morphological changes of
condyle in patients with apparently symmetrical face and
no TMD.
2. To assess positional and morphological changes of
condyle in patients with facial asymmetry associated with
TMD.
3. To assess positional and morphological changes of
condyle in patients with facial asymmetry not associated
TMD.
|
1 group
To compare the positional and morphological changes
of condyle in patients with apparently symmetrical face
and no TMD; with that of subjects with facial asymmetry
with/ without TMD. |
| Intervention |
Cone Beam Computed Tomography |
CBCT equipment of the
company DENTRI (HDX WILL CORPORATION, Korea),ON-DEMAND 3D software. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Control group:
Patients without mandibular asymmetry.
No previous orthodontic treatment
Patients greater than 18 years of age.
Full permanent dentition.
Experimental group:
Patients with mandibular asymmetry greater than 2mm.
No previous orthodontic treatment.
Patients greater than 18 years of age.
Full permanent dentition
|
|
| ExclusionCriteria |
| Details |
TMJ -Trauma/surgery/Fracture.
Treatment with occlusal splints.
Previous orthodontic treatment.
Prosthetic crowns and bridges.
Orthognathic surgery.
Missing / malformed teeth/supernumerary teeth.
Congenital / Systemic disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Condylar position within the glenoid fossa:
Anterior, superior, and posterior joint spaces
Depth of mandibular fossa
Condylar morphology:
Anteroposterior and mediolateral diameters
Condylar angle to mid-sagittal plane
Distance of condylar center to midline
Asymmetry in geometric position between right and left condyles |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Association between condylar changes and presence of facial asymmetry and/or TMD symptoms.
This includes:
Correlation of morphological/positional deviations with clinical presence of:
Facial asymmetry greater than 2 mm
TMD symptoms (as diagnosed using a validated questionnaire)
Differences in CBCT-derived metrics between the groups:
Control group (symmetrical, no TMD)
Facial asymmetry with TMD
Facial asymmetry without TMD
This outcome reflects the comparative and diagnostic significance of the findings. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/07/2025 |
| 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="0"
Months="6"
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
|
Morphological and Positional Assessment of Condyle in Facial Asymmetry Patients with or without Temporomandibular Disorders: A CBCT Study
Background:
Facial asymmetry can influence not only dental occlusion but also the morphology and position of the temporomandibular joint (TMJ), possibly leading to temporomandibular disorders (TMD). Variations in condylar position and shape are believed to play a critical role in these conditions. Cone Beam Computed Tomography (CBCT) is a valuable diagnostic tool for evaluating these structures in three dimensions with reduced radiation exposure.
Aim:
To evaluate and compare the positional and morphological changes of the mandibular condyle in patients with facial asymmetry, with and without TMD, using CBCT.
Objectives:
-
Assess condylar morphology and position in symmetrical patients without TMD (control group).
-
Assess the same parameters in asymmetrical patients with TMD.
-
Assess the same parameters in asymmetrical patients without TMD.
-
Compare findings across all three groups.
Study Design:
-
Type: Prospective, observational, multi-arm, cross-sectional study
-
Sample size: 66 participants (22 in each group)
-
Grouping: Based on presence of facial asymmetry and TMD
-
Method: Clinical exam, validated TMD questionnaire, CBCT imaging
Primary Outcome:
-
Condylar positional and morphological parameters on CBCT, including joint spaces, condylar dimensions, and alignment.
Secondary Outcome:
Time Points:
All outcomes are assessed once at baseline, during initial CBCT scan and questionnaire assessment.
Statistical Analysis:
Conclusion (anticipated):
This study aims to provide insights into how condylar morphology and position vary with facial asymmetry and TMD, potentially aiding in early diagnosis and treatment planning using CBCT. |