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临床试验/CTRI/2025/09/094889
CTRI/2025/09/094889尚未招募4 期

Comparative evaluation of caries progression on tooth surfaces adjacent to primary molars treated with the Hall technique versus nano-filled composite restorations : A randomized clinical study

Dr Ritambhra Dikshit1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2025年9月30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
39
试验地点
1
主要终点
• Change in carious lesion status: Evaluation of the progression or arrest of caries on adjacent tooth surfaces.

研究概览

简要总结

Introduction Dental caries is a widespread chronic disease caused by the interaction of dietary sugars, bacteria, and host factors leading to tooth demineralization. Its progression is driven by an imbalance between demineralization and remineralization. Prevention and management are vital to oral health and quality of life. Conventional management relied on removing carious dentin and restoring with materials such as composites, glass ionomer cements, and amalgam but this often required significant tooth structure removal. The Hall technique is a minimally invasive approach in which a preformed metal crown is placed over a carious primary molar without tooth preparation. It seals the lesion, inactivates bacteria, and arrests caries progression. Literature supports its effectiveness, but little evidence exists on its impact on adjacent tooth surfaces compared to modern materials like nano filled composites.

Aim To compare and evaluate caries progression on tooth surfaces adjacent to primary molars treated with the Hall technique versus nano filled composite restoration.

Objectives The primary objective is to compare progression of caries on adjacent tooth surfaces. Secondary objectives are to evaluate survival rate of treatments and assess patient acceptance and satisfaction.

Hypothesis There is a significant difference in efficacy of the Hall technique and nano filled composite restorations in preventing progression of caries on adjacent surfaces.

Review of Literature Studies from 2019 to 2024 have compared the Hall technique with conventional restorations and atraumatic restorative treatment. Findings generally show higher success rates, lower failure rates, and good acceptance for the Hall technique. Research on nanofilled composites shows clinically acceptable results and potential advantages in restoring primary molars.

Methodology The randomized controlled study will be conducted in the Department of Paediatric and Preventive Dentistry at King Georges Medical University Lucknow. Ethical approval and informed consent will be obtained. Participants will be children aged five to nine years with primary molars having occluso proximal caries. Exclusion applies to those needing pulp therapy, with poor compliance, lacking adjacent teeth, with systemic issues, or unwilling to participate.

The sample size is thirty nine per group after adjustment for attrition. Participants will be randomly allocated into two groups. Group A will receive Hall technique treatment with preformed metal crowns. Group B will receive nano filled composite restorations with cavity preparation and bonding.

Outcomes The primary outcome is change in carious lesion status on adjacent tooth surfaces assessed at baseline six months and twelve months using ICDAS. Secondary outcomes are restoration survival rate at twelve months, patient behavior during treatment, patient satisfaction, and reported pain or discomfort.

Data Collection and Analysis Caries status will be analyzed using non parametric tests. Survival rate will be analyzed with Kaplan Meier survival analysis and log rank test. Patient satisfaction and acceptability will be summarized descriptively. A probability value less than 0.05 will be considered statistically significant.

研究设计

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

入排标准

年龄范围
5.00 Year(s) 至 9.00 Year(s)(—)
性别
All

入选标准

  • Patients with at least one primary molar presenting multisurface or occluso-proximal dentine caries lesions.
  • Adjacent tooth surfaces classified as sound or initial stage carious lesions based on ICDAS merged categories at baseline.
  • Cooperative children rated as definitely positive or positive on the Frankl Behavioural Rating Scale.
  • Parents or guardians who provide consent for participation in the study.

排除标准

  • Patients with primary molars requiring pulp therapy or endodontic treatment.
  • Patients with poor oral hygiene compliance or those unlikely to adhere to follow-up schedules.
  • Patients with carious primary molars without adjacent teeth present.
  • Patients with metabolic disorders or medically compromised conditions
  • Patients who are not willing to participate in the study.

结局指标

主要结局

• Change in carious lesion status: Evaluation of the progression or arrest of caries on adjacent tooth surfaces.

时间窗: • T0 (baseline), T1 (at 6 months post intervention) and T2 | (at 12 months post intervention).

次要结局

  • 1. Restoration survival rate: Assessment of restoration longevity and integrity over the 12-month follow-up period.(2. Patient behavior during treatment)

研究者

发起方
Dr Ritambhra Dikshit
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Ritambhra Dikshit

King George Medical College

研究点 (1)

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