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临床试验/NCT07687654
NCT07687654招募中不适用

Clinical Evaluation of the Root Coverage Performance of Different Restorative Materials in Class V Cavities in Patients With Gingival Recession

Zeliha Başak Çakır Erdil1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Percentage of Root Coverage

研究概览

简要总结

This prospective randomized controlled clinical trial aims to evaluate the influence of different restorative materials placed in Class V cervical lesions on the clinical outcomes of root coverage surgery using a subepithelial connective tissue graft. Patients with Cairo RT1 (Miller Class I-II equivalent) gingival recession associated with non-carious cervical lesions or existing cervical restorations will receive one of the restorative approaches according to the study protocol. Clinical parameters, including the percentage of root coverage and soft tissue stability, will be evaluated during follow-up to determine which restorative approach provides the most favorable clinical outcome.

详细描述

Gingival recession associated with non-carious cervical lesions (NCCLs) is a common clinical condition that may result in dentin hypersensitivity, root caries, and esthetic concerns. When root coverage surgery is indicated, the presence or absence of a cervical restoration and the type of restorative material may influence soft tissue healing and the stability of the surgical outcome. However, evidence regarding the optimal restorative approach before periodontal plastic surgery remains limited.

This prospective randomized controlled clinical trial will compare the clinical performance of different restorative approaches in Class V cervical lesions undergoing root coverage surgery with a subepithelial connective tissue graft. Eligible patients presenting with Cairo RT1 (Miller Class I-II equivalent) gingival recession and Class V cervical defects will be allocated to one of the study groups according to the study protocol. The interventions include restoration with glass ionomer cement, resin composite or no restoration when appropriate.

All participants will receive standardized periodontal treatment before surgery, followed by root coverage surgery using a subepithelial connective tissue graft. Clinical examinations will be performed at baseline and during follow-up to evaluate treatment outcomes.

The primary outcome is the percentage of root coverage achieved after surgery. Secondary outcomes include changes in gingival recession depth, clinical attachment level, keratinized tissue width, probing depth, dentin hypersensitivity, esthetic outcomes, and the clinical stability of the treated sites. The findings will help determine whether the restorative material placed in Class V cervical lesions influences the success of periodontal root coverage procedures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 years or older. Patients presenting with Cairo RT1 (Miller Class I or II equivalent) gingival recession defects requiring root coverage surgery.
  • Presence of a non-carious cervical lesion (NCCL), an existing cervical restoration, or a cervical defect requiring restoration.
  • Cervical lesion depth of ≤1.5 mm. Patients who have completed initial periodontal therapy before enrollment. Good oral hygiene (Plaque Index ≤20% or as determined by the investigator). Indication for root coverage surgery with a subepithelial connective tissue graft.
  • Teeth suitable for restoration with glass ionomer cement, resin composite, or flowable resin composite, or requiring no restoration according to the study protocol.
  • Ability and willingness to provide written informed consent and comply with study visits.

排除标准

  • Age younger than 18 years. Pregnancy or breastfeeding. Poor oral hygiene. Uncontrolled systemic disease or any medical condition contraindicating periodontal surgery.
  • Bleeding disorders or current anticoagulation that contraindicates connective tissue graft harvesting.
  • Known allergy or hypersensitivity to resin composite, flowable resin composite, glass ionomer cement, or any study materials.
  • Patients who have not completed initial periodontal therapy. Cervical lesions deeper than 1.5 mm. Conditions that, in the investigator's opinion, could interfere with wound healing, periodontal surgery, or study outcomes.

结局指标

主要结局

Percentage of Root Coverage

时间窗: Baseline to 6 months after surgery

The percentage of root coverage will be evaluated after root coverage surgery in Class V cervical lesions treated with different restorative approaches, including glass ionomer, resin composite, flowable composite, or no restoration. The outcome will assess which material or approach provides greater soft tissue coverage over the cervical/root surface.

次要结局

未报告次要终点

研究者

发起方
Zeliha Başak Çakır Erdil
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zeliha Başak Çakır Erdil

Research Assistant Dr. in Periodontology

Adiyaman University

研究点 (1)

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