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临床试验/CTRI/2025/03/082613
CTRI/2025/03/082613尚未招募3 期

A COMPARISON OF POST- OPERATIVE HYPERSENSITIVITY AND MARGINAL INTEGRITY OF COMPOSITE RESIN RESTORATIONS IN PERMANENT POSTERIOR TEETH USING TOTAL-ETCH AND ONE-STEP UNIVERSAL ADHESIVE SYSTEM: A RANDOMIZED CONTROLLED TRIAL

Dr Shruti1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2025年3月24日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
39
试验地点
1
主要终点
Post Operative Sensitivity will be evaluated based upon VAS

研究概览

简要总结

This Randomized Controlled Trial (RCT) enrolled patients meeting specific eligibility criteria, requiring at least two Class I carious lesions (ICDAS 4) extending to dentin but not exceeding half the distance to the DEJ.

Patients were randomly assigned to two groups:

Group A: Total-Etch Adhesive System (5th Generation)

Group B: One-Step Universal Adhesive System (8th Generation)

All cavities were restored using nanohybrid composite resin with the incremental technique, followed by finishing and polishing.

Evaluation Parameters:

Post-operative hypersensitivity assessed using VAS immediately, at 24 hours, and 7 days post-procedure.

Marginal discoloration and adaptation evaluated at 3 and 6 months using USPHS criteria.

All data collected will undergo statistical analysis to compare the effectiveness of both adhesive systems.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Age 18-45 years.
  • No previous sensitivity to hot/cold.
  • Good oral hygiene.
  • Patients with at least 2 carious posterior teeth with class I caries extended to dentin (ICDAS 4) not more than one-half the distance between pulp and Dentino-enamel junction (DEJ).
  • A periodontally sound and asymptomatic vital tooth.
  • Patient who are able to provide informed consent.

排除标准

  • Deep carious lesion extending near pulp.
  • Uncontrolled Diabetes.
  • Parafunctional Habits such as Bruxism, Clenching of teeth.
  • Abnormal occlusion.
  • Teeth with increased pre-operative sensitivity.
  • Non-vital teeth with pulp necrosis or irreversible pulpitis.

结局指标

主要结局

Post Operative Sensitivity will be evaluated based upon VAS

时间窗: 24 hours, 1 week

次要结局

  • Marginal adaptation and Discoloration(3 months , 6 months)

研究者

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

Dr Shruti

Himachal Dental College and Hospital, Sundernagar

研究点 (1)

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