Gingival RecessionNCT07687654
Root Coverage Performance of Restorative Materials in Class V Cavities
A study testing Glass Ionomer Cement Group and Resin Composite Group in people with Gingival Recession and Non-Carious Cervical Lesions (NCCLs), run by Zeliha Başak Çakır Erdil at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gingival Recession, Non-Carious Cervical Lesions (NCCLs)
- What is being tested?
- Glass Ionomer Cement Group and Resin Composite Group
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Metin Çalışır, Prof.DR contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Adıyaman University
Adıyaman, Merkez, 02030
Zeliha B ÇAKIR ERDİL, 05059444038, bskcakirr@gmail.com
Zeliha Başak ÇAKIR ERDİL, DDS
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- No Restoration Control Group, Glass Ionomer Cement Group, Resin Composite Group
- Keywords
- Gingival Recession, Non-Carious Cervical Lesion, Root Coverage, Glass Ionomer Cement, Resin Composite, Class V Restoration, Subepithelial Connective Tissue Graft, Randomized Controlled Trial
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Restoration Control GroupProcedure or 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.
Glass Ionomer Cement GroupDevice
A conventional glass ionomer cement was used to restore the Class V cervical lesion before root coverage surgery with a subepithelial connective tissue graft.
Resin Composite GroupDevice
A resin composite material was used to restore the Class V cervical lesion before root coverage surgery with a subepithelial connective tissue graft.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Resin Composite Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start20 Nov 2025
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeliha Başak Çakır Erdil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeliha Başak Çakır Erdil, Adiyaman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687654
- Sponsor's protocol ID
- HRU-25.18.53
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because of institutional policies and participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Root Coverage Performance of Different Restorative Materials in Class V Cavities in Patients With Gingival Recession
- ClinicalTrials.gov ID
- NCT07687654
- Acronym / sponsor ID
- HRU-25.18.53
- Keywords
- Gingival Recession, Non-Carious Cervical Lesion, Root Coverage, Glass Ionomer Cement, Resin Composite, Class V Restoration, Subepithelial Connective Tissue Graft, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zeliha Başak Çakır ErdilUniversity, hospital or other
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Restoration Control Grou | Active comparator | Procedure: No Restoration Control GroupParticipants 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. |
| Glass Ionomer Cement Group | Experimental | Device: Glass Ionomer Cement GroupParticipants 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. |
| Resin Composite Group | Experimental | Device: Resin Composite GroupParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Restoration Control GroupNo 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. | Procedure or surgery | No Restoration Control Grou |
| Glass Ionomer Cement GroupA conventional glass ionomer cement was used to restore the Class V cervical lesion before root coverage surgery with a subepithelial connective tissue graft. | Device | Glass Ionomer Cement Group |
| Resin Composite GroupA resin composite material was used to restore the Class V cervical lesion before root coverage surgery with a subepithelial connective tissue graft. | Device | Resin Composite Group |
Primary outcome
Percentage of Root Coverage
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because of institutional policies and participant confidentiality.
Related trials for Gingival Recession
Recruiting
Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
Active, not recruiting
Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for Miller Class I Gingival Recession
Gingival Recession
Not yet recruiting
Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
Soft Tissue Augmentation, Gingival Recession Localized Moderate
Recruiting
Effects of Low-Level Laser Therapy and Hyaluronic Acid After Free Gingival Graft
Gingival Recession, Mucogingival Surgery
Recruiting
Impact of Root Surface Conditioning With Erythritol Air Polishing and Hand Instrumentation on Recession Coverage Using the Modified Tunnel Technique and Subepithelial Connective Tissue Graft.
Gingival Recession
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Metin Çalışır, Prof.DR contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glass Ionomer Cement Group and Resin Composite Group in people with Gingival Recession and Non-Carious Cervical Lesions (NCCLs), run by Zeliha Başak Çakır Erdil at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeliha B ÇAKIR ERDİL, DDS (+905059444038, bskcakirr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Root Coverage (time frame: Baseline to 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026; AzTrials last refreshed its copy on 29 Oct 2026.