Root Coverage Performance of Restorative Materials in Class V Cavities

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура No Restoration Control Group
  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.
• Устройство Glass Ionomer Cement Group
  A conventional glass ionomer cement was used to restore the Class V cervical lesion before root coverage surgery with a subepithelial connective tissue graft.
• Устройство Resin Composite Group
  A resin composite material was used to restore the Class V cervical lesion before root coverage surgery with a subepithelial connective tissue graft.

Первичные конечные точки

• Percentage of Root Coverage [Срок оценки: Baseline to 6 months after surgery]

Критерии участия

Критерии включения

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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Faculty of Dentistry, Adıyaman University — Adıyaman

Идентификаторы

NCT: NCT07687654 · HRU-25.18.53

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗