| CTRI Number |
CTRI/2025/04/085329 [Registered on: 22/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Quality of life after full mouth dental treatment in special children |
|
Scientific Title of Study
|
Oral Health Related Quality of Life Post Oral Rehabilitation under General Anesthesia in Children with Mild Intellectual Disability |
| 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 Aishani Baksi |
| Designation |
Postgraduate student |
| Affiliation |
AB Shetty Memorial Institute of Dental Sciences |
| Address |
Room no 15, 4th floor, Department of Pediatric & Preventive Dentistry, AB Shetty Memorial Institute of Dental Sciences, Nithyanand Nagar, Deralakatte, Mangaluru 575018, Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9800930633 |
| Fax |
|
| Email |
aishanibaksi23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Manju R |
| Designation |
Professor & Head of the Department |
| Affiliation |
AB Shetty Memorial Institute of Dental Sciences |
| Address |
Room no 15, 4th floor, Department of Pediatric & Preventive Dentistry, AB Shetty Memorial Institute of Dental Sciences, Nithyanand Nagar, Deralakatte, Mangaluru 575018, Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845451954 |
| Fax |
|
| Email |
hod.pedo.absmids@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Manju R |
| Designation |
Professor & Head of the Department |
| Affiliation |
AB Shetty Memorial Institute of Dental Sciences |
| Address |
Room no 15, 4th floor, Department of Pediatric & Preventive Dentistry, AB Shetty Memorial Institute of Dental Sciences, Nithyanand Nagar, Deralakatte, Mangaluru 575018, Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845451954 |
| Fax |
|
| Email |
hod.pedo.absmids@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Aishani Baksi |
| Address |
Room no 15, 4th floor, Department of Pediatric & Preventive Dentistry, AB Shetty Memorial Institute of Dental Sciences, Nithyanand Nagar,Deralakatte, Mangaluru 575018, Karnataka |
| 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 |
| Prof Dr Manju R |
AB Shetty Memorial Institute of Dental Sciences |
Room no 15, 4th floor, Department of Pediatric & Preventive Dentistry, NITTE Deemed to be University, Nithyanand Nagar,Deralakatte, Mangaluru 575018, Karnataka
Dakshina Kannada
KARNATAKA |
9845451954
hod.pedo.absmids@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
TOTAL ORAL REHABILITATION |
Total oral rehabilitation in children (including oral prophylaxis, pit and fissure sealants, fluoride application, atraumatic restorative treatment, pulp therapy, extractions) followed by diet counselling and reinforcement of oral hygiene |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children with mild intellectual disability between the age group of 6-12 years as specified by the DSM-5 classification given by the American Psychiatric association and having Intelligence Quotient in the range of 55-69.
Children with mild intellectual disability having multiple caries.
Children whose parents are well motivated and have knowledge about full mouth rehabilitation under general anesthesia and willing to give informed consent.
|
|
| ExclusionCriteria |
| Details |
Children with moderate, severe, profound and unspecified intellectual disability as specified by the DSM-5 classification given by the American Psychiatric association.
Children with Intelligence Quotient below 55, under anti-anxiety medication or with a history of seizures or with hearing and visual impairment
Medically compromised children and uncooperative children
Children whose parents are not willing to give their consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of oral rehabilitation on oral health related quality of life in children |
Before and 1 month after oral rehabilitation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Parental perception of effect of oral rehabilitation on oral health related quality of life in children |
Before and 1 month after oral rehabilitation |
|
|
Target Sample Size
|
Total Sample Size="17"
Sample Size from India="17"
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)
|
01/05/2025 |
| 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="1"
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
|
Children between the age group of 6-12 years of either gender with mild intellectual disability having Intelligence Quotient in the range of 55-69 as specified by DSM-5 classification given by American Psychiatric Association with multiple caries will be considered for the study. Parents who give consent for oral rehabilitation under general anesthesia will be made to fill the pre validated version of the oral health related quality of life questionnaire. Total oral rehabilitation in children (including oral prophylaxis, pit and fissure sealants, fluoride application, atraumatic restorative treatment, pulp therapy, extractions) followed by diet counselling and reinforcement of oral hygiene instructions for the parents/care givers will be carried out. 1 month after oral rehabilitation, parents will be asked to again fill the oral health related quality of life questionnaire. Data will be compared and statistically analysed. |