| CTRI Number |
CTRI/2024/02/063333 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
20/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of decay pattern in milk tooth |
|
Scientific Title of Study
|
Assessment of interproximal caries pattern in primary molars - A longitudinal 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. Sriabinaya S |
| Designation |
Post graduate student |
| Affiliation |
Rajiv Gandhi University of Health Sciences |
| Address |
Department of Pediatric and Preventive dentistry, room no. 8, 4th floor,
The Oxford Dental College,
Bommanahalli,
Bengaluru,
Karnataka
Bangalore
KARNATAKA
560068
India |
| Phone |
8884613113 |
| Fax |
|
| Email |
sriabiselva@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Kiran.K |
| Designation |
Proffessor |
| Affiliation |
Rajiv Gandhi University of Health Sciences |
| Address |
Department of Pediatric and Preventive Dentistry, room no.8, 4th floor, The Oxford Dental College,
Bommanahalli,
Bengaluru,
Karnataka
Bangalore
KARNATAKA
560068
India |
| Phone |
9731196369 |
| Fax |
|
| Email |
drkkiran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Sriabinaya S |
| Designation |
Post graduate student |
| Affiliation |
Rajiv Gandhi University of Health Sciences |
| Address |
Department of Pediatric and Preventive Dentistry, Room no. 8, 4th floor, The Oxford Dental College,
Bommanahalli,
Bengaluru,
Karnataka
Bangalore
KARNATAKA
560068
India |
| Phone |
8884613113 |
| Fax |
|
| Email |
sriabiselva@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive dentistry, room no. 8, 4th floor,
The Oxford Dental College,
Bommanahalli,
Bengaluru,
Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr SriabinayaS |
| Address |
Department of Pediatric and Preventive dentistry, room no. 8, 4th floor,
The Oxford Dental College,
Bommanahalli,
Bengaluru,
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 |
| Dr Sriabinaya S |
The Oxford Dental College |
Department of Pediatric and Preventive dentistry, room no. 8, 4th floor,
The Oxford Dental College,
Bommanahalli,
Bengaluru,
Karnataka
Bangalore
KARNATAKA |
8884613113
sriabiselva@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, The oxford dental college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
dental caries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Class 2 Restoration |
GIC type 9 GC Gold Label high strength posterior restorative,
Duration 6months - 1 year |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1 Healthy and cooperative children
2 Children having fully erupted primary dentition.
3 Presence of interproximal caries in primary molars
|
|
| ExclusionCriteria |
| Details |
• Absence of any primary molar
• Pulpally involved primary molars
• Children undergone topical fluoride during the study period
• Medically compromised children
• Any developmental disturbances in primary molars
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| progression of dental caries |
6months - 1year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| promote early dental care in children |
6months - 1year |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
04/03/2024 |
| 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="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
|
The children will be divided into groups according to distribution of interproximal caries at first visit. Group 1: Presence of interproximal caries in primary molars in any one quadrant only Group 2: Presence of bilateral interproximal caries in either maxillary or mandibular arch Group 3: Presence of unilateral caries in upper and lower arches Standardized intra oral bitewing radiographs of the primary molars will be taken and the interproximal caries will be scored. Clinical photographs of maxillary and mandibular arches will be used for evaluation of marginal ridge break down.3 The carious teeth will then be restored and oral hygiene instructions given. The children will be recalled at 3 month intervals over a period of one year and assessed for presence of marginal ridge breakdown and cavitated interproximal caries in primary molars in other quadrants. During the study period, the parents will be advised to follow routine oral hygiene practices. |