| CTRI Number |
CTRI/2025/07/092043 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Understanding Gum Health in Preschoolers: A Study on Plaque and Gingival Thickness |
|
Scientific Title of Study
|
Comparative risk assessment of marginal gingival thickness and accumulation of plaque in pre-school children-a cross-sectional 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 |
KRISHNA SALIL |
| Designation |
MDS Student |
| Affiliation |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL VIJAYAWADA ANDHRA PRADESH |
| Address |
Government Dental College and Hospital ,ESI ROAD Gunadala Vijayawada,Krishna District,AndhraPradesh,India
Krishna
ANDHRA PRADESH
520004
India |
| Phone |
9618810707 |
| Fax |
|
| Email |
drkrishnasalil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.G.Jesudass |
| Designation |
Professor and HOD |
| Affiliation |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL VIJAYAWADA ANDHRA PRADESH |
| Address |
Government dental college and hospital, ESI road,vijayawada, krishna district , Andhra Pradesh,India
Krishna
ANDHRA PRADESH
520004
India |
| Phone |
|
| Fax |
|
| Email |
jesudass.govada@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KRISHNA SALIL |
| Designation |
MDS STUDENT |
| Affiliation |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL VIJAYAWADA ANDHRA PRADESH |
| Address |
Government dental college and hospital, ESI road Gunadala, Vijayawada, krishna district, Andhra pradesh,India
Krishna
ANDHRA PRADESH
520004
India |
| Phone |
8281872123 |
| Fax |
|
| Email |
drkrishnasalil@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KRISHNA SALIL |
| Address |
Government dental college and hospital, ESI road, Gunadala , vijayawada , krishna district, Andhra Pradhesh,India |
| 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 |
| DRKRISHNA SALIL |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL VIJAYAWADA ANDHRA PRADESH |
Department of pediatric and preventive dentistry, room no 7
Krishna
ANDHRA PRADESH |
08281872123
drkrishnasalil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE,GOVERNMENT DENTAL COLLEGE &HOSPITAL , VIJAYAWADA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
routine dental checkup |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
not applicable |
not applicable |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1)Participants who gave voluntary consent
2)caries free maxillary and mandibular 1st and 2nd molars of children with age group of 3-5 years
3)Children who are systemically healthy
4)Children not under any medication since 3 weeks
5)Absence of any gingival and periodontal diseases
|
|
| ExclusionCriteria |
| Details |
1)Children with gingival and periodontal diseases
2)Carious deciduous molars
3)Uncooperative children
4)Children who were using any medication, mentally or physically challenged children, the presence of dental structure anomalies
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| thinner gingiva seen to accumulate more plaque |
1week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| there is no variation in gingival thickness among tooth on right & left side of the tooth |
1week |
|
|
Target Sample Size
|
Total Sample Size="280"
Sample Size from India="280"
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)
|
11/08/2025 |
| 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="3"
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
|
Primary teeth have a thicker marginal gingiva than
permanent teeth due to the prominent cervical bulge and constricted
cementoenamel junction. The correlation observed between the average plaque
index and gingival thickness suggests that increased plaque buildup may be a
contributing factor to gingival inflammation |