| CTRI Number |
CTRI/2026/04/107337 [Registered on: 01/04/2026] Trial Registered Prospectively |
| Last Modified On: |
31/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Cross-Sectional Clinical Evaluation of Oral Hygiene Status, Dental Caries Experience (DMFT Index), Developmental Dental Anomalies, and Malocclusion in Non-Syndromic Children Aged 6–18 Years with Cleft Lip and Palate. |
|
Scientific Title of Study
|
Clinical analysis of dental health, caries status, developmental anomalies and malocclusion in children with Cleft Lip and Palate of age group 6-18 years. |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aishwarya Malu |
| Designation |
Post graduate student |
| Affiliation |
Sri Sai College of Dental Surgery |
| Address |
Sri Sai College of Dental Surgery,
1-2-64/1 AND 2, Opposite Shiv Sagar Lake,
Kothrepally, Vikarabad, Telangana, India 501102.
Sri Sai College of Dental Surgery,
1-2-64/1 AND 2, Opposite Shiv Sagar Lake,
Kothrepally, Vikarabad, Telangana, India 501102.
Hyderabad
TELANGANA
501102
India |
| Phone |
9121186677 |
| Fax |
|
| Email |
aishwaryamalu13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR CH SAMPATH REDDY |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
Sri Sai college of Dental Surgery |
| Address |
Sri Sai College of Dental Surgery,
1-2-64/1 AND 2, Opposite Shiv Sagar Lake,
Kothrepally, Vikarabad, Telangana, India 501102.
Sri Sai College of Dental Surgery,
1-2-64/1 AND 2, Opposite Shiv Sagar Lake,
Kothrepally, Vikarabad, Telangana, India 501102.
Hyderabad
TELANGANA
501102
India |
| Phone |
9121186677 |
| Fax |
|
| Email |
sampathcheruku@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR CH SAMPATH REDDY |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
SriSai college of Dental Surgery |
| Address |
Sri Sai College of Dental Surgery,
1-2-64/1 AND 2, Opposite Shiv Sagar Lake,
Kothrepally, Vikarabad, Telangana, India 501102.
Sri Sai College of Dental Surgery,
1-2-64/1 AND 2, Opposite Shiv Sagar Lake,
Kothrepally, Vikarabad, Telangana, India 501102.
Hyderabad
TELANGANA
501102
India |
| Phone |
9121186677 |
| Fax |
|
| Email |
sampathcheruku@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR AISHWARYA MALU |
| Address |
Sri Sai College of Dental Surgery,
1-2-64/1 AND 2, Opposite Shiv Sagar Lake,
Kothrepally, Vikarabad, Telangana,India 501102 |
| 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 AISHWARYA MALU |
GSR INSTITUTE OF CRANIOFACIAL SURGERY . |
GSR INSTITUTE OF CRANIOFACIAL SURGERY,#17-1-383/55,
Vinaynagar Colony, Saidabad,
Hyderabad 500059
Telangana, India.
Hyderabad
TELANGANA |
9121186677
aishwaryamalu13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SAI COLLEGE OF DENTAL SURGERYIEC 2024-25 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q378||Unspecified cleft palate with bilateral cleft lip, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Patients in mixed dentition age from 6 to 18 years, with non syndromic congenital cleft lip and palate patients will be selected. Written informed consent will be obtained from the parents /guardians. |
|
| ExclusionCriteria |
| Details |
Patients with syndromic cleft lip and palate. Medically compromised patients will not be included. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of dental caries status in children with cleft lip and palate using the DMFT index This will quantify the prevalence and severity of caries in the study population |
At baseline single time point during clinical examination |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
08/05/2026 |
| 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="0"
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
|
Children with cleft lip and palate are at increased risk of dental problems due to altered oral anatomy and difficulty in maintaining oral hygiene This observational cross sectional study will clinically assess oral hygiene status dental caries Malocclusion and Developmental dental anomalies in children aged 6 to 18 years with non syndromic cleft lip and palate this study aims to evaluate the overall oral health status and associated dental conditions in these patients |