跳至主要内容
临床试验/CTRI/2025/12/098373
CTRI/2025/12/098373尚未招募Phase 3 4

Comparative Evaluation of Composite Based Pediatric Esthetic Crowns and Zirconia Crowns A 12 Month Follow up Study

NARESHVIKRAMAN V1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年12月15日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
The integrity of the restoration after 12 months” or “failure rate of crowns”.

研究概览

简要总结

The present in vivo study aims to clinically evaluate and compare the performance of composite-based pediatric esthetic crowns with that of zirconia crowns in primary molars. The primary objective is to assess the anatomic form, integrity of restoration, color match, and other clinical parameters over a one-year period. The study includes two groups: Group A comprising Edelweiss composite crowns and Group B comprising zirconia crowns, with each group consisting of twenty-five samples. Children aged 4 to 8 years who require full-coverage restorations following pulpotomy or pulpectomy and are otherwise healthy without systemic diseases or developmental dental disturbances will be included in the study. Exclusion criteria include children with parafunctional habits, teeth exhibiting internal resorption, inadequate crown structure, furcation involvement, or more than two-thirds root resorption. All crown placements will be carried out by a single operator to ensure consistency in clinical procedures. The clinical success of the restorations will be evaluated by a single calibrated examiner through visual examination using modified USPHS criteria. Additional parameters such as opposing tooth wear, gingival inflammation, and plaque accumulation will also be assessed at intervals of 3, 6, 9, and 12 months. This study seeks to determine whether composite-based esthetic crowns offer comparable or superior performance to zirconia crowns in terms of esthetics, function, and biological compatibility over a one-year evaluation period.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
4.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • Patient between the age group of four to eight years.
  • Primary molars requiring full coverage restoration following pulpectomy or pulpotomy.
  • Healthy children free of any systemic disease or any developmental disturbances of teeth.

排除标准

  • Child with parafunctional habits.
  • Teeth with internal resorption.
  • Teeth with inadequate crown structure.
  • Infection involving the furcation areas Tooth with more than two-third of root resorption.

结局指标

主要结局

The integrity of the restoration after 12 months” or “failure rate of crowns”.

时间窗: 1 YEAR

次要结局

  • Secondary outcomes include color match, gingival health, marginal adaptation, or patient satisfaction.(1 YEAR)

研究者

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

NARESHVIKRAMAN V

Madha dental college and hospital

研究点 (1)

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