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临床试验/CTRI/2026/01/102297
CTRI/2026/01/102297尚未招募4 期

Preventive Management of Developmental Dental Defects in Children of Gestational Diabetic Mother: A Clinical Trial

Akshayakumar S1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2026年2月2日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
280
试验地点
1
主要终点
To determine how frequently DDD occurs in 3-4 yrs born to GDM mothers

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
3.00 Day(s) 至 4.00 Day(s)(—)
性别
All

入选标准

  • Children born to GDM mothers.

排除标准

  • Children with any other systemic or localised illness.

结局指标

主要结局

To determine how frequently DDD occurs in 3-4 yrs born to GDM mothers

时间窗: To determine how frequently DDD occurs in 3-4 yrs born to GDM mothers

次要结局

  • 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)

研究者

发起方
Akshayakumar S
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Akshayakumar S

Chettinad Dental College and Research Institute

研究点 (1)

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