| CTRI Number |
CTRI/2025/10/095782 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Assessing oral health in Cleft lip and Palate patients during upper jaw expansion |
|
Scientific Title of Study
|
Evaluation of Oral Health in Unilateral Cleft Lip and Palate Patients Undergoing Maxillary Expansion: A Periodontal and Microbiological 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 |
Dr Riddhi Bansal |
| 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 India
Faridabad
HARYANA
121003
India
Faridabad
HARYANA
121003
India |
| Phone |
08827269156 |
| Fax |
|
| Email |
Bansalriddhi4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Puneet Batra |
| Designation |
Pro-vice-chancellor Dean (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 India
Faridabad
HARYANA
121003
India
Faridabad
HARYANA
121003
India |
| Phone |
9810335961 |
| Fax |
|
| Email |
drpuneetbatra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Puneet Batra |
| Designation |
Pro-vice-chancellor Dean (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 India
Faridabad
HARYANA
121003
India
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 India Pin- 121003 |
|
|
Primary Sponsor
|
| Name |
Dr Riddhi Bansal |
| Address |
Manav Rachna Dental College School of Dental Sciences MRIIRS
Department no 3 Ground floor Surajkund Road Faridabad |
| 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 Riddhi Bansal |
MANAV RACHNA DENTAL COLLEGE |
Department of
Orthodontics and
Dentofacial Orthopedics
Room no 3
Ground floor Surajkund
Road Faridabad
Faridabad
HARYANA |
08827269156
Bansalriddhi4@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: Q375||Cleft hard and soft palate with unilateral cleft lip, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aligners |
Maxillary expansion will be done with Aligners till the arch is expanded and crossbite is corrected and assessment changes in periodontal status and microbiota of plaque |
| Intervention |
Ni-Ti palatal expander |
Maxillary expansion will be done with Ni-Ti palatal expander till the arch is expanded and crossbite is corrected and assessment changes in periodontal status and microbiota of plaque |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
Complete unilateral cleft lip and palate
Age 7 to 11 years
Both sexes |
|
| ExclusionCriteria |
| Details |
Syndromic cleft lip and palate patients
Individuals with systemic diseases affecting bone density
Bilateral cleft lip and palate patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To analyze periodontal status and the microbiota of plaque in patients with cleft lip and palate undergoing orthodontic treatment for maxillary expansion with NiTi palatal expander or clear Aligners.
|
T0- Baseline
T1- After completion of expansion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
29/10/2025 |
| 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
|
Cleft lip and palate (CLP), one of the most prevalent craniofacial abnormalities, accounts for about 15% of all congenital deformities worldwide. Patients with CLP have a higher risk of periodontal disease due to poorly developed hard tissue structures, altered soft tissues, and developmental disturbances affecting tooth structure, form, and number, particularly in the upper incisors near the cleft region. While a few studies have compared periodontal health and subgingival plaque microbes in cleft and non-cleft areas, no research has examined these factors in CLP patients undergoing orthodontic maxillary expansion with different appliances. This study aims to evaluate the periodontal status and plaque microbiota in CLP patients treated with NiTi palatal expanders or clear Aligners. |