| CTRI Number |
CTRI/2024/08/072626 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
16/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Bioactive restoration in proximal primary molars.
|
|
Scientific Title of Study
|
In vivo – evaluation of a novel bioactive restorative resin in proximal restorations of primary molars- A comparative 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 ARUN E |
| Designation |
Professor and Head Of the Department |
| Affiliation |
Madha Dental College |
| Address |
Madha Dental College
Somangalam Main Rd, Madha Nagar, Kundrathur, Chennai, Sikkarayapuram, Tamil Nadu 600069
Kancheepuram TAMIL NADU 600069 India |
| Phone |
9585111025 |
| Fax |
|
| Email |
bilal4u93@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR ARUN E |
| Designation |
PROFESSOR & HEAD OF THE DEPARTMENT |
| Affiliation |
MADHA DENTAL COLLEGE |
| Address |
MADHA DENTAL COLLEGE
Somangalam Main Rd, Madha Nagar, Kundrathur, Chennai, Sikkarayapuram, Tamil Nadu 600069
Kancheepuram TAMIL NADU 600069 India |
| Phone |
9585111025 |
| Fax |
|
| Email |
arunetam@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
DR ARUN E |
| Designation |
PROFESSOR & HEAD OF THE DEPARTMENT |
| Affiliation |
MADHA DENTAL COLLEGE |
| Address |
MADHA DENTAL COLLEGE
Somangalam Main Rd, Madha Nagar, Kundrathur, Chennai, Sikkarayapuram, Tamil Nadu 600069
Kancheepuram TAMIL NADU 600069 India |
| Phone |
9941377203 |
| Fax |
|
| Email |
bilal4u93@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KHADER SHERIFF |
| Address |
ICON DENTAL CARE
NO 38
NH1
VALLAL MGR SALAI
MARAI MALAI NAGAR
603209 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| SHIFA |
ICON DENTAL CARE
NO 38
NH1
VALLAL MGR SALAI
MARAI MALAI NAGAR
603209 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrBilal |
madha dental college |
Somangalam Main Rd, Madha Nagar, Kundrathur, Chennai, Sikkarayapuram, Tamil Nadu 600069 Kancheepuram TAMIL NADU |
9585111025
bilal4u93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MADHA DENTAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patients with class II dental caries affecting the primary molars |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DrBilal |
Postgraduate |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Apparently healthy and cooperative.
Children in the age range of 4 to 9 years.
Children with clinically detectable proximal carious lesions. (ICDAS II Scores 3,4,5) |
|
| ExclusionCriteria |
| Details |
Primary teeth with deep carious lesions / pain
Children who are on iron supplements or any other medication that can cause discolouration of the teeth & restoration.
Children with special health care needs / uncooperative children / lack of compliance.
Children with the evidence of parafunctional habits.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To check the different restoration used in proximal areas of primary tooth |
3 months interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To check the different restoration used in proximal areas of primary tooth |
3 month period |
|
|
Target Sample Size
|
Total Sample Size="258" Sample Size from India="258"
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)
|
28/08/2024 |
| 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)
|
Open to Recruitment |
| 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
|
Restorative therapy is a part of comprehensive dental care for management of dental caries that depends on several factors such as caries-risk assessment, longevity and durability of the dental materials, type of restoration necessitated, patients’ cooperation towards treatment, and development status of the primary/permanent dentition, anticipated compliances, and other environmental influences. Conventional restorative procedures of extensively damaged or destroyed carious teeth is a challenging task as removal of the tooth was the principal mode of treatment for the primary tooth particularly at the anterior region in the past followed by replacement with an artificial prosthetic substitute until the eruption of permanent tooth. This may result in psychological impact on the child by affecting the confidence and normal personality development apart from esthetical compromise, abnormal habits and speech difficulties. Restorative materials used in pediatric dentistry should possess specific characteristics such as biocompatibility, durability, aesthetics, and ease of use, to ensure successful outcomes. This study aims to explore a new restorative material that meets these requirements and can potentially enhance the quality of pediatric dental care. |