| CTRI Number |
CTRI/2025/07/091813 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
27/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Risk of caries in different types of contacts of teeth |
|
Scientific Title of Study
|
Prevalence of initial proximal caries in 3-6 years age children with OXIS contacts- 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 |
P Manasa |
| Designation |
MDS student |
| Affiliation |
Government Dental College and Hospital Vijayawada |
| Address |
Department of pediatric and preventive dentistry room number 7 Government Dental College and Hospital ESI road Gunadala Vijayawada krishna district Andhra Pradesh 520008
Krishna ANDHRA PRADESH 520004 India |
| Phone |
07981717816 |
| Fax |
|
| Email |
pujarimanasa97@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
G Jesudass |
| Designation |
Professor & HOD |
| Affiliation |
Government Dental College and Hospital Vijayawada |
| Address |
Department of pediatric and preventive dentistry room number 7 Government Dental College and Hospital ESI road Gunadala Vijayawada krishna district Andhra Pradesh 520008
Krishna ANDHRA PRADESH 520004 India |
| Phone |
9618810707 |
| Fax |
|
| Email |
jesudass.govada@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
P Manasa |
| Designation |
MDS student |
| Affiliation |
Government Dental College and Hospital Vijayawada |
| Address |
Department of pediatric and preventive dentistry room number 7 Government Dental College and Hospital ESI road Gunadala Vijayawada krishna district Andhra Pradesh 520008
Krishna ANDHRA PRADESH 520004 India |
| Phone |
7981717816 |
| Fax |
|
| Email |
pujarimanasa97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of pediatric and preventive dentistry Government Dental College and Hospital ESI road Gunadala Vijayawada krishna district Andhra Pradesh 520008 India |
|
|
Primary Sponsor
|
| Name |
Manasa Pujari |
| Address |
Government dental college and hospital, ESI Road Gunadala Vijayawada krishna dist Andhra Pradesh 520008 Vijayawada |
| 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 |
| Dr Manasa Pujari |
Government dental college and hospital Vijayawada |
Department of pediatric and preventive dentistry room number 7 ESI road Gunadala Vijayawada krishna district Andhra Pradesh 520008 India Krishna ANDHRA PRADESH |
07981717816
pujarimanasa97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee GDCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
not applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Age 3- 6 years
Presence of primary molars |
|
| ExclusionCriteria |
| Details |
Age morethan 6 years
Absence of primary molars
Grossly decayed primary molars |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reducing the risk of caries |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="167" Sample Size from India="167"
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)
|
15/08/2025 |
| 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="6" 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
|
To
assess the prevalence of initial proximal caries in 3-6-year-old children
with
OXIS contacts [O (open contact), X (point contact), I (straight contact), and S
(curved contact)]. Their significance can be understood through their impact on
dental health, occlusion, and overall oral development.
Materials
and Methods: A sample of 167 primary molar contacts from
children aged 3–6 years was examined. Clinical assessments were conducted using
mouth mirrors and probes under adequate lighting to classify contacts as O, X,
I, or S. Intraoral periapical radiographs or Radiovisiography were used to
detect initial proximal caries. The association between contact type and caries
prevalence was analysed using the Chi-square test. Clinical
Significance: Understanding contact types aids clinicians in
recognising caries-prone areas and restoring complex contacts to reduce caries
risk, enhancing oral health outcomes. Previous
studies have different criteria to determine the nature of contact between
primary molars as open/ closed contact12,13. They concluded that
closed contact has a potential risk for caries. In the present study, I type of
contact was most prevalent with initial caries followed by S type, consistent
with findings of Kirthiga M et al, Muthu M S et al. Those authors reported that
S and I type contacts had higher odds of developing caries than X and O type.
This susceptibility could be due to higher plaque accumulation that may occur
beneath closed contacts and additionally retained plaque in these areas may be
difficult to remove using standard tooth brushing methods. The concavity
followed by convexity in this design (S type) forms a favourable niche for
plaque accumulation.
The
assessment of contact areas is essential to understand the risk of initial
caries development and progression, to account for the preparation of proximal
cavity and maintenance of appropriate contact after the placement of
restorations and crowns.
|