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CTRI Number  CTRI/2026/01/102297 [Registered on: 28/01/2026] Trial Registered Prospectively
Last Modified On: 21/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Preventive dental care for Tooth Problems in Children of Mothers with Diabetes During Pregnancy 
Scientific Title of Study   Preventive Management of Developmental Dental Defects in Children of Gestational Diabetic Mother: A Clinical Trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Akshayakumar S 
Designation  Post Graduate 
Affiliation  Chettinad Dental College and Research Institute 
Address  Room no 6, 3rd floor, Pediatric and Preventive Dentistry, Chettinad Dental College and Research Institute, Rajiv Gandhi Salai, Kelambakkam, Chennai, TamilNadu 603103, India

Chennai
TAMIL NADU
603103
India 
Phone  7598746906  
Fax    
Email  akshayakumarsen@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Daya Srinivasan 
Designation  Professor & Head 
Affiliation  Chettinad Dental College and Research Institute 
Address  Room no 6, 3rd floor, Pediatric and Preventive Dentistry, Chettinad Dental College and Research Institute, Rajiv Gandhi Salai, Kelambakkam, Chennai, TamilNadu 603103, India

Chennai
TAMIL NADU
603103
India 
Phone  9884476385  
Fax    
Email  dayaswathi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Daya Srinivasan 
Designation  Professor & Head 
Affiliation  Chettinad Dental College and Research Institute 
Address  Room no 6, 3rd floor, Pediatric and Preventive Dentistry, Chettinad Dental College and Research Institute, Rajiv Gandhi Salai, Kelambakkam, Chennai, TamilNadu 603103, India

Chennai
TAMIL NADU
603103
India 
Phone  9884476385  
Fax    
Email  dayaswathi@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Akshayakumar S  
Address  Dept of Pediatric and Preventive Dentistry, room no 6, 3rd floor, E block, Chettinad dental College and Research Institute, Kelambakkam  
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 
Akshayakumar S  Chettinad Dental College and Research Institute  Room no 6, 3rd floor, Pediatric and Preventive Dentistry, Chettinad Dental College and Research Institute, Rajiv Gandhi Salai, Kelambakkam, Chennai, TamilNadu 603103, India
Chennai
TAMIL NADU 
7598746906

akshayakumarsen@gmail.com 
 
Details of Ethics Committee  
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K004||Disturbances in tooth formation, (2) ICD-10 Condition: O244||Gestational diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Proanthocyanidin-rich, non-fluoridated gel (in-office) + Arginine-rich toothpaste (home use)  Proanthocyanidin-rich, non-fluoridated gel (in-office) + Arginine-rich toothpaste (home use) 
Comparator Agent  Standard fluoride toothpaste (routine care)  Standard fluoride toothpaste (routine care) 
 
Inclusion Criteria  
Age From  3.00 Day(s)
Age To  4.00 Day(s)
Gender  Both 
Details  Children born to GDM mothers 
 
ExclusionCriteria 
Details  Children with any other systemic or localised illness  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine how frequently DDD occurs in 3-4 yrs born to GDM mothers  To determine how frequently DDD occurs in 3-4 yrs born to GDM mothers 
 
Secondary Outcome  
Outcome  TimePoints 
To access whether the Preventive intervention reduces the severity of halts the progression of enamel defects over follow up period.  At baseline & 4 weeks & 8 weeks 
 
Target Sample Size   Total Sample Size="280"
Sample Size from India="280" 
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   Phase 4 
Date of First Enrollment (India)   02/02/2026 
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="1"
Months="0"
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  
Developmental Dental Defects (DDD) manifest as hypoplasia, opacities, and surface irregularities in enamel. These conditions weaken tooth structure, increasing vulnerability to caries. The prenatal period is critical in amelogenesis, during which environmental and systemic maternal factors can influence enamel development. One such factor is Gestational Diabetes Mellitus (GDM), characterized by glucose intolerance during pregnancy.
Maternal hyperglycemia alters the intrauterine environment, which may disrupt ameloblast function and enamel matrix formation in the fetus. Consequently, children born to GDM mothers may show a higher prevalence of DDD, predisposing them to early-onset dental disease.
Despite mounting evidence on this association, most dental preventive strategies focus on postnatal risk factors, neglecting maternal metabolic influences. This creates a gap in identifying and managing children with prenatally acquired dental vulnerabilities. Additionally, most early childhood oral health programs emphasize fluoride use, whereas fluoride-free alternatives like proanthocyanidin (a natural collagen stabilizer with remineralization potential) and arginine-based toothpaste (which supports biofilm regulation) are less explored in clinical settings.
This study aims to bridge these gaps by determining the association between maternal GDM and DDD in offspring and evaluating the clinical impact of a non-fluoride-based preventive approach. Using high-resolution intraoral photographs with software-assisted analysis, enamel defects will be systematically recorded. A targeted intervention will be implemented in diagnosed cases to test its preventive effectiveness.
By integrating obstetric history into pediatric dental care, the study emphasizes a preventive, interdisciplinary model that could inform clinical practices and public health guidelines in high-risk populations such as India, where GDM prevalence is rising steadily.
 
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