| CTRI Number |
CTRI/2025/10/096196 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
03/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
An Observational Study on Different Kinds of Tooth Contacts in the Primary Teeth of Preschool Children |
|
Scientific Title of Study
|
Prevalence of Different Types of Interproximal Contact in the Primary Dentition Among 3 to 5 Years Aged Preschool Children in and Around Rural Areas of Jaipur, Rajasthan:
An Observational Study.
|
| Trial Acronym |
OXIS-Jaipur Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chaya Chhabra |
| Designation |
Professor and HOD |
| Affiliation |
NIMS university |
| Address |
DEPARTMENT NO 7 DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY NIMS DENTAL COLLEGE AND HOSPITAL NIMS UNIVERSITY
NIL
Jaipur
RAJASTHAN
303121
India |
| Phone |
9929535666 |
| Fax |
|
| Email |
chaya.chhabra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Eemana Bhat |
| Designation |
Postgraduate |
| Affiliation |
NIMS Dental Collge And Hospital |
| Address |
NIMS Dental College And Hospital, NIMS University, B S Tomar City, Shobha Nagar, Jaipur-Delhi Highway, Jaipur, Rajasthan- 303121
room no. 7, NIMS Dental College And Hospital, NIMS University, B S Tomar City, Shobha Nagar, Jaipur-Delhi Highway, Jaipur, Rajasthan- 303121
Jaipur
RAJASTHAN
303121
India |
| Phone |
9596538899 |
| Fax |
|
| Email |
eemanabhat0@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chaya Chhabra |
| Designation |
Professor and HOD |
| Affiliation |
NIMS university |
| Address |
DEPARTMENT NO 7 DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY NIMS DENTAL COLLEGE AND HOSPITAL NIMS UNIVERSITY
NIL
Jaipur
RAJASTHAN
303121
India |
| Phone |
9929535666 |
| Fax |
|
| Email |
chaya.chhabra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nims Dental College and Hospital Nims University Rajasthan jaipur |
|
|
Primary Sponsor
|
| Name |
Dr Eemana |
| Address |
Camellia Girls Hostel 1401 Nims University Rajasthan Jaipur 303121 |
| 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 Eemana Farooq |
NIMS Dental College |
NIMS dental College and Hospital, NIMS University, B S Tomar City, Shobha Nagar, Jaipur-Delhi Highway, Jaipur, Rajasthan- 303121
Jaipur
RAJASTHAN |
9596538899
eemanabhat0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS UNIVERSITY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K002||Abnormalities of size and form ofteeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Children aged between 3 to 5 years
Children having good oral hygiene
Children who co-operate in the generation of impression
Children with no visible dental plaque on the quadrants to be include
|
|
| ExclusionCriteria |
| Details |
Child with special healthcare needs
Presence of developmental anomalies in sizes and shape of the teeth
Presence of proximal caries in between contact areas of primary teeth
Child having severe gag reflex
Any defects in the cast will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the prevalence (O) of different types of interproximal contacts in primary dentition (X) among preschool children aged 3–5 years (I) in rural areas of Jaipur |
At the time of clinical examination (baseline, single visit only) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcomes of this study include assessing the association between interproximal contact types and age groups—specifically three, four, and five years of age—as well as evaluating the distribution of contact types based on dental arch, comparing maxillary and mandibular teeth, gender differences, and variations between anterior and posterior tooth types. Additionally, the study aims to identify which specific type of interproximal contact is more susceptible to the development of dental caries, thereby providing insights into early risk indicators in primary dentition among preschool children. |
baseline |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
01/11/2025 |
| 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="1"
Months="1"
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
|
This study investigates the prevalence of various types of interproximal contacts in the primary dentition of preschool children aged 3 to 5 years in rural areas around Jaipur, Rajasthan. The research aims to assess how these contacts vary among this demographic, providing insights into dental health and development in young children. By evaluating the interproximal spaces, the study highlights potential implications for dental practices and early intervention in oral care for preschoolers in these regions. The types of interproximal contacts (I, S, O, and X) in caries-free three- to four-year-olds, finding that contact type I is the most prevalent. |