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临床试验/NCT07212413
NCT07212413进行中(未招募)不适用

Postoperative Sensitivity in Class II Restorations: A Randomized Clinical Trial Comparing Snow-Plow and Resin Coating Techniques

University of Jordan1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月12日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
100
试验地点
1
主要终点
Postoperative pain intensity after Class II composite restorations

研究概览

简要总结

This study is designed to compare two modern techniques used to restore decayed back teeth with tooth-colored filling materials. Some patients experience temporary discomfort or sensitivity after these types of dental treatments. The purpose of this study is to learn whether one technique may help reduce this short-term sensitivity compared to the other.

Adults who need fillings on both sides of their mouth are invited to participate. Each patient will receive one filling using each technique, placed in different teeth during the same appointment. The procedures will be performed using standard clinical methods and materials.

After treatment, participants will be contacted by telephone to report any discomfort at several time points during the first week. The interviewer will not know which technique was used for each tooth to ensure unbiased reporting. This information will help dentists better understand how these techniques affect patients' comfort in the days following treatment.

详细描述

Postoperative tooth sensitivity is a common but often transient symptom following the placement of direct posterior resin composite restorations. Patients frequently report mild to moderate discomfort, particularly during the first few days after treatment, which can influence their perception of treatment success and overall satisfaction. While advances in adhesive dentistry and restorative materials have greatly improved clinical outcomes, postoperative sensitivity remains a relevant clinical concern.

This clinical trial is designed to compare two contemporary restorative techniques-the snow-plow technique and the resin coating technique following immediate dentin sealing-in terms of postoperative patient-reported pain during the first postoperative week. Both techniques aim to enhance marginal adaptation and reduce polymerization shrinkage stresses at the adhesive interface, thereby potentially minimizing pulpal irritation and postoperative discomfort.

Participants in this study are adult patients requiring Class II resin composite restorations on two comparable posterior teeth, typically located on opposite sides of the dental arch. Each participant will receive two restorations, one using the snow-plow technique and the other using the resin coating technique, in a split-mouth design. This approach allows each participant to serve as their own control, minimizing inter-patient variability and enabling a more reliable comparison between the two restorative strategies.

All procedures are performed under rubber dam isolation using standardized adhesive and restorative protocols to ensure clinical consistency. The snow-plow technique involves placing an uncured flowable bulk-fill resin on the cavity floor, immediately followed by the placement of a packable composite increment. Both materials are then light-cured simultaneously. This technique is intended to improve adaptation of the restorative material to cavity walls, displace voids, and reduce microleakage.

In the resin coating technique, immediate dentin sealing is performed following cavity preparation. A thin layer of flowable bulk-fill resin is then applied over the sealed dentin and light-cured before the placement of the final packable composite increment. This layer acts as a stress-absorbing liner, providing a flexible interface that may protect the pulp and reduce the transmission of shrinkage stresses during polymerization.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The outcomes assessor was blinded to the restorative technique used on each tooth. Telephone interviews were conducted using standardized scripts, and the interviewer was unaware of the allocation, referring to teeth by quadrant/side to minimize bias. The operator is not blinded due to the nature of the restorative procedures.

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients aged 18-50 years.
  • Systemically healthy individuals.
  • Presence of two posterior teeth in different quadrants or contralateral sides of the same arch requiring Class II composite restorations.
  • Teeth diagnosed with reversible pulpitis and vital pulps, confirmed clinically and radiographically.
  • Teeth without previous restorations or carious lesions limited to dentin.
  • Ability to provide informed consent and comply with study procedures and follow-up assessments.

排除标准

  • Non-vital teeth, teeth with signs of irreversible pulpitis, periapical pathology, or extensive loss of tooth structure.
  • Patients with systemic conditions or medications that may influence pain perception, healing, or sensitivity (e.g., chronic pain syndromes, analgesic use, immunosuppressive therapy), or very poor oral hygiene.
  • Pregnant or breastfeeding women.
  • Known allergy to dental materials used in the study.
  • Inability to respond to follow-up calls or provide reliable pain assessments.
  • Teeth with previous restorations, endodontic treatment, or cracks.

结局指标

主要结局

Postoperative pain intensity after Class II composite restorations

时间窗: Baseline, 24 hours, 72 hours, and 1 week after restorative treatment

Postoperative pain intensity will be assessed using a 0-10 Visual Analog Scale (VAS) at baseline (before treatment), 24 hours, 72 hours, and 1 week following restorative procedures. Each treated tooth will be evaluated individually using structured telephone interviews conducted by a blinded examiner. VAS scores will be recorded and analyzed to compare pain trajectories between the snow-plow and resin coating restorative techniques.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alaa Al-Haddad

Assisstant profossor in restorative dentistry

University of Jordan

研究点 (1)

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