| 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
|
|
|
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
|
|
|
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. |