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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.


 
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