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CTRI Number  CTRI/2026/02/104708 [Registered on: 25/02/2026] Trial Registered Prospectively
Last Modified On: 24/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Association between Palatal Rugae Pattern and Dental Caries in Primary Teeth 
Scientific Title of Study   Role of Palatal Rugae Pattern as A Predictor of Dental Caries in Primary Dentition: 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  Dr Rumela Ash 
Designation  Postgraduate Student 
Affiliation  Sardar Patel Post Graduate Institute of Dental and Medical Sciences  
Address  Department of Pediatric and Preventive Dentistry, Floor no. 3, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow.

Lucknow
UTTAR PRADESH
226025
India 
Phone  8017972758  
Fax    
Email  drrumelaash@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amit Rai 
Designation  Reader 
Affiliation  Sardar Patel Post Graduate Institute of Dental and Medical Sciences 
Address  Department of Pediatric and Preventive Dentistry, Floor no. 3, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow.

Lucknow
UTTAR PRADESH
226025
India 
Phone  9453268177  
Fax    
Email  dr.amitrai001@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rumela Ash 
Designation  Postgraduate Student 
Affiliation  Sardar Patel Post Graduate Institute of Dental and Medical Sciences 
Address  Department of Pediatric and Preventive Dentistry, Floor no. 3, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow.

Lucknow
UTTAR PRADESH
226025
India 
Phone  8017972758  
Fax    
Email  drrumelaash@gmail.com  
 
Source of Monetary or Material Support  
Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow, Uttar Pradesh, India, PIN: 226025 
 
Primary Sponsor  
Name  Dr Rumela Ash 
Address  Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow, Uttar Pradesh, India, PIN: 226025 
Type of Sponsor  Other [Self] 
 
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 Rumela Ash  Sardar Patel Post Graduate Institute of Dental and Medical Sciences  Department of Pediatric and Preventive Dentistry, Floor no. 3, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow.
Lucknow
UTTAR PRADESH 
8017972758

drrumelaash@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Age between 3 to 6 years 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  1. The participants who will be willing to take part in the study and consent will be taken from the parents.
2. Outpatients aged between 3 to 6 years.
3. Children with no history of systemic disease or oral anomalies. 
 
ExclusionCriteria 
Details  1. Uncooperative children.
2. Children with special health care needs.
3. Children with a history of systemic illness, congenital anomalies, trauma of the maxillofacial region and medications altering the salivary flow of the patient.
4. Children with cleft lip and palate, supernumerary teeth, congenitally missing teeth and dentoalveolar abscess. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine if there is an Association Between Palatal Rugae pattern and Caries Severity in Children.   2 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To observe the Frequency & Distribution of Palatal Rugae Patterns in Children
To investigate the Potential Use of Palatal Rugae in Predicting the Risk of Dental Caries in Children 
2 Weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   08/03/2026 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Palatal rugae are asymmetrical mucosal ridges located on the anterior palate that develop during the third month of intrauterine life and remain stable throughout an individual’s lifetime. Genetically determined and resistant to postmortem changes, they share a common ectodermal origin with enamel-forming tooth buds. This developmental similarity suggests a possible association between palatal rugae patterns and dental conditions such as dental caries.

Dental caries is a highly prevalent chronic disease in children, causing pain, infection, and tooth loss. Although environmental, behavioural, and genetic factors influencing caries are well documented, the role of anatomical markers in predicting caries risk remains underexplored. Early identification of children at higher risk is essential for implementing preventive strategies and reducing long-term oral health complications.

This study aims to investigate the frequency and distribution of palatal rugae patterns in children and to evaluate their association with the presence and severity of dental caries in primary dentition. It further seeks to determine whether specific rugae characteristics—such as number, shape, and arrangement—can serve as non-invasive, cost-effective predictors of caries risk. The findings may contribute to improved risk assessment and preventive approaches in Pediatric Dentistry.

 
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