Root Coverage Performance of Restorative Materials in Class V Cavities

NCT07687654 | Recruiting

• 1 other identifier: HRU-25.18.53
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gingival Recession; Non-Carious Cervical Lesions (NCCLs)

Keywords

Gingival Recession; Non-Carious Cervical Lesion; Root Coverage; Glass Ionomer Cement; Resin Composite; Class V Restoration; Subepithelial Connective Tissue Graft; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Percentage of Root Coverage

  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

Study Arms (3)

No Restoration Control Grou

ACTIVE COMPARATOR

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.

Procedure: No Restoration Control Group

Glass Ionomer Cement Group

EXPERIMENTAL

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.

Device: Glass Ionomer Cement Group

Resin Composite Group

EXPERIMENTAL

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.

Device: Resin Composite Group

Interventions

No Restoration Control Group PROCEDURE

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.

No Restoration Control Grou

Glass Ionomer Cement Group DEVICE

A conventional glass ionomer cement was used to restore the Class V cervical lesion before root coverage surgery with a subepithelial connective tissue graft.

Glass Ionomer Cement Group

Resin Composite Group DEVICE

A resin composite material was used to restore the Class V cervical lesion before root coverage surgery with a subepithelial connective tissue graft.

Resin Composite Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zeliha Başak Çakır Erdil: lead

Study Sites (1)

Faculty of Dentistry, Adıyaman University

Adıyaman, Merkez, 02030, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Central Study Contacts

Zeliha B ÇAKIR ERDİL, DDS

CONTACT

+905059444038; bskcakirr@gmail.com

Metin Çalışır, Prof.DR

CONTACT

metincalisir@adiyaman.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant Dr. in Periodontology

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 7, 2026
• Study Start: November 20, 2025
• Primary Completion: August 1, 2026
• Study Completion: August 1, 2026
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)