| 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
|
|
|
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
|
|
|
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
|
|
|
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. |