| CTRI Number |
CTRI/2024/04/065547 [Registered on: 10/04/2024] Trial Registered Prospectively |
| Last Modified On: |
08/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
To assess the health of jaw joint and muscles attached to it, in patients with cut on one side of lip and roof of the mouth, undergoing treatment with braces.
|
|
Scientific Title of Study
|
Assessment of the Temporomandibular Joint Health, Occlusal Load Distribution and Masticatory Function in patients with Unilateral Cleft Lip and Palate following Orthodontic Treatment : A Prospective 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 |
Dr Minakshi Tibrewal |
| Designation |
Post Graduate Student |
| Affiliation |
Manav Rachna Dental College |
| Address |
Manav Rachna Dental College school of Dental Sciences MRIIRS Department no 3 Ground Floor Surajkund Road Faridabad Haryana 121003
Faridabad
HARYANA
121003
India |
| Phone |
9919695319 |
| Fax |
|
| Email |
tibrewalminakshi13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Puneet Batra |
| Designation |
Principal (Prof) HOD |
| Affiliation |
Manav Rachna Dental College |
| Address |
Manav Rachna Dental College school of Dental Sciences MRIIRS Department no 3 Ground Floor Surajkund Road Faridabad Haryana 121003
Faridabad
HARYANA
121003
India |
| Phone |
9810335961 |
| Fax |
|
| Email |
drpuneetbatra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Puneet Batra |
| Designation |
Principal (Prof) HOD |
| Affiliation |
Manav Rachna Dental College |
| Address |
Manav Rachna Dental College school of Dental Sciences MRIIRS Department no 3 Ground Floor Surajkund Road Faridabad Haryana 121003
Faridabad
HARYANA
121003
India |
| Phone |
9810335961 |
| Fax |
|
| Email |
drpuneetbatra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manav Rachna Dental College School of Dental Sciences MRIIRS Department no 3 Ground Floor Surajkund Road Faridabad Haryana |
|
|
Primary Sponsor
|
| Name |
Dr Minakshi Tibrewal |
| Address |
Manav rachna Dental College School of Dental Sciences MRIIRS Department no 3 Ground Floor Surajkund Road Faridabad Haryana 121003 |
| Type of Sponsor |
Other [Self-funded] |
|
|
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 Minakshi Tibrewal |
Manav Rachna Dental College |
Manav Rachna Dental College School of dental Sciences MRIIRS Department no 3 Ground Floor Surajkund Road Faridabad Haryana
Faridabad
HARYANA |
9919695319
tibrewalminakshi13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Manav Rachna Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q371||Cleft hard palate with unilateralcleft lip, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fixed Orthodontic Treatment |
Fixed Orthodontic Treatment for 1 to 1.5 years |
| Comparator Agent |
Pre and Post Orthodontic Treatment |
Pre orthodontic treatment and post orthodontic treatment records to be compared |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Repaired unilateral cleft lip and palate patients with GOSLON Yardstick group
1, 2 and 3.
Age group between 14-30 years
Systemically healthy patients. |
|
| ExclusionCriteria |
| Details |
Syndromic unilateral cleft lip and patients.
Patients with bilateral cleft lip and palate.
Patients requiring orthognathic surgery. Patients with signs or symptoms of myofascial disorders causing discomfort
or pain of the masticatory musculature |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Temporomandibular Joint
sounds, Amplitude peak
(pascals) and Frequency peak
(Hertz), Bite force(occlusal load), Electrical activity of masseter
and anterior temporalis muscle
at rest and maximum voluntary
clenching(µV/µV%) |
T0 before fixed orthodontic treatment - At baseline
T1 after fixed orthodontic treatment - After 18 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Temporomandibular Joint Disorder & masticatory efficiency(Molar extinction coefficient(ε)
per gram of carrot) |
T0 before fixed orthodontic treatment - At baseline
T1 after fixed orthodontic treatment - After 18 months
|
|
|
Target Sample Size
|
Total Sample Size="14"
Sample Size from India="14"
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 4 |
|
Date of First Enrollment (India)
|
30/04/2024 |
| 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="0"
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
|
In this study, patients with Unilateral Cleft Lip and Palate will be evaluated for temporomandibular joint health using Joint Vibrational Analysis(JVA), Occlusal load Distribution using T-Scan, Masticatory function using Electromyography and Masticatory Efficiency using colorimetric method before orthodontic treatment and after orthodontic treatment . Changes in the temporomandibular joint health, occlusal load distribution, masticatory function and masticatory efficiency will be compared before and after orthodontic treatment. |