| CTRI Number |
CTRI/2024/06/069407 [Registered on: 24/06/2024] Trial Registered Prospectively |
| Last Modified On: |
13/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Disorders of the jaw joint in Individuals with and without Unilateral Complete Cleft Lip and Palate |
|
Scientific Title of Study
|
Assessment of Occurrence and Comparison of Temporomandibular Disorders in Individuals with and without Unilateral Complete Cleft Lip and Palate Using Helkimo Index and Radiographic Analysis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Utkarsha Chaudhari |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
102 Deparment of Orthodontics and Dentofacial Orthopaedics SPDC DMIHER Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
942315488 |
| Fax |
|
| Email |
drutkarshac@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pallavi Daigvane |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
102 Deparment of Orthodontics and Dentofacial Orthopaedics SPDC DMIHER Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9923355361 |
| Fax |
|
| Email |
pallavi.daigavane15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pallavi Daigvane |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
102 Deparment of Orthodontics and Dentofacial Orthopaedics SPDC DMIHER Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9923355361 |
| Fax |
|
| Email |
pallavi.daigavane15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research Wardha-442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe Wardha Maharashtra-442001 |
| Type of Sponsor |
Private medical college |
|
|
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 Utkarsha Chaudhari |
Sharad Pawar Dental College |
102, Department of Orthodontics and Dentofacial Orthopaedics, SPDC BUilding DMIHER Sawangi Wardha-442001
Wardha
MAHARASHTRA |
942315488
drutkarshac@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NA |
| Comparator Agent |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Complete Unilateral cleft lip and palate
2. Age group of 18 and above
3. Surgically treated individual at 1 year of age
4. Angle’s Class I (ANB angle 0-4º) |
|
| ExclusionCriteria |
| Details |
1. Bilateral cleft lip /palate
2. Only lip and anterior alveolus cleft Patients
3. Syndromic cleft patients
4. TMJ Ankylosis patients
5. Skeletal and dentoalveolar Class II, Class III
6.Cases with missing teeth
7. Grossly carious teeth
8. Open bites
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The proposed study in intended to highlight the occurrence and also severity of temporomandibular joint (TMJ) disorders in individuals with unilateral cleft lip and palate (UCLP) is crucial for enhancing patient care |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| . Identifying potential risk factors associated with TMJ development in UCLP patients is essential for preventive strategies & targeted interventions. Moreover, the findings contribute to the refinement of diagnostic approaches for TMJ disorders in individuals with cleft lip & palate, improving the accuracy & timeliness of detection. |
1 month |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
02/07/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The proposed study in intended to highlight the
occurrence and also severity of temporomandibular joint (TMJ) disorders in
individuals with unilateral complete cleft lip and palate (UCLP) is crucial for
enhancing patient care. Research in this area aims to shed light on the
prevalence and impact of TMJ disorders in the cleft population, providing
valuable insights into the specific challenges faced by complete UCLP individuals.
Identifying potential risk factors associated with TMJ development in complete UCLP
patients is essential for preventive strategies and targeted interventions.
Moreover, the findings contribute to the refinement of diagnostic approaches
for TMJ disorders in individuals with cleft lip and palate, improving the
accuracy and timeliness of detection. Ultimately, this research not only
addresses the immediate clinical concerns related to TMJ disorders in complete UCLP
individuals but also adds to the broader understanding of the intricate
relationship between cleft lip and palate and craniofacial development,
fostering advancements in comprehensive patient care and management. |