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Root Coverage Performance of Restorative Materials in Class V Cavities

2026年6月30日 更新者:Zeliha Başak Çakır Erdil

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

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

30

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Zeliha B ÇAKIR ERDİL, DDS
  • 电话号码:+905059444038
  • 邮箱:bskcakirr@gmail.com

研究联系人备份

学习地点

    • Merkez
      • Adıyaman、Merkez、土耳其(türkiye)、02030
        • 招聘中
        • Faculty of Dentistry, Adıyaman University
        • 接触:
        • 副研究员:
          • Zeliha Başak ÇAKIR ERDİL, DDS
        • 首席研究员:
          • METİN ÇALIŞIR, Prof.Dr.

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:No Restoration Control Grou
Participants will be randomly assigned to one of three parallel groups: no restoration control, glass ionomer cement restoration, or resin composite restoration before root coverage surgery.
No restorative material will be placed in the Class V cervical lesion before root coverage surgery. Participants will undergo root coverage surgery using a coronally advanced flap with a subepithelial connective tissue graft according to the study protocol.
实验性的:Glass Ionomer Cement Group
Participants will receive restoration of the Class V cervical lesion with glass ionomer cement before root coverage surgery using a subepithelial connective tissue graft. Clinical outcomes, including the percentage of root coverage and soft tissue healing, will be evaluated during follow-up.
A conventional glass ionomer cement was used to restore the Class V cervical lesion before root coverage surgery with a subepithelial connective tissue graft.
实验性的:Resin Composite Group
Participants will receive restoration of the Class V cervical lesion with resin composite before root coverage surgery using a subepithelial connective tissue graft. Clinical outcomes, including the percentage of root coverage and soft tissue healing, will be evaluated during follow-up.
A resin composite material was used to restore the Class V cervical lesion before root coverage surgery with a subepithelial connective tissue graft.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Percentage of Root Coverage
大体时间: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.
Baseline to 6 months after surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年11月20日

初级完成 (估计的)

2026年8月1日

研究完成 (估计的)

2026年8月1日

研究注册日期

首次提交

2026年6月30日

首先提交符合 QC 标准的

2026年6月30日

首次发布 (实际的)

2026年7月7日

研究记录更新

最后更新发布 (实际的)

2026年7月7日

上次提交的符合 QC 标准的更新

2026年6月30日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data will not be shared because of institutional policies and participant confidentiality.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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