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Hyaluronic Acid With Connective Tissue Grafting for Gingival Recession

NCT ID: NCT07291583

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-07-01

Brief Summary

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This study evaluates whether adding 0.8% hyaluronic acid (HA) to connective tissue grafting and coronally advanced flap surgery improves clinical and esthetic outcomes in the treatment of gingival recession. Adult patients with Miller I-II or Cairo RT1 recession defects will be randomly assigned to receive CTG alone or CTG with adjunctive HA. Mean root coverage at 6 months is the primary outcome, while secondary measures include gingival thickness, clinical attachment level, esthetic scores, postoperative morbidity, and quality of life. The study aims to determine whether HA enhances soft tissue healing and root coverage predictability compared with conventional CTG.

Detailed Description

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Conditions

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Gingival Recession

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Experimental - CTG + Hyaluronic Acid

A 0.8% hyaluronic acid (HA) gel is applied to the connective tissue graft (CTG) before flap closure during the coronally advanced flap (CAF) procedure. The HA gel is used as an adjunctive biologic material to potentially enhance wound healing, soft tissue thickness, esthetic outcomes, and overall root coverage performance.

Group Type EXPERIMENTAL

Hyaluronic Acid (0.8%) - Applied over CTG before flap closure (Test group only).

Intervention Type BIOLOGICAL

A 0.8% hyaluronic acid (HA) gel is applied to the connective tissue graft (CTG) before flap closure during the coronally advanced flap (CAF) procedure. The HA gel is used as an adjunctive biologic material to potentially enhance wound healing, soft tissue thickness, esthetic outcomes, and overall root coverage performance

Connective Tissue Graft + Coronally Advanced Flap (CTG + CAF)

Intervention Type PROCEDURE

A standardized coronally advanced flap (CAF) procedure combined with a subepithelial connective tissue graft (CTG) is performed to treat gingival recession defects. The surgical protocol includes flap elevation, graft harvesting and placement, and flap advancement and suturing.

CTG only

A standardized coronally advanced flap (CAF) procedure combined with a subepithelial connective tissue graft (CTG) is performed to treat gingival recession defects. The surgical protocol includes flap elevation, graft harvesting and placement, and flap advancement and suturing.

Group Type ACTIVE_COMPARATOR

Connective Tissue Graft + Coronally Advanced Flap (CTG + CAF)

Intervention Type PROCEDURE

A standardized coronally advanced flap (CAF) procedure combined with a subepithelial connective tissue graft (CTG) is performed to treat gingival recession defects. The surgical protocol includes flap elevation, graft harvesting and placement, and flap advancement and suturing.

Interventions

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Hyaluronic Acid (0.8%) - Applied over CTG before flap closure (Test group only).

A 0.8% hyaluronic acid (HA) gel is applied to the connective tissue graft (CTG) before flap closure during the coronally advanced flap (CAF) procedure. The HA gel is used as an adjunctive biologic material to potentially enhance wound healing, soft tissue thickness, esthetic outcomes, and overall root coverage performance

Intervention Type BIOLOGICAL

Connective Tissue Graft + Coronally Advanced Flap (CTG + CAF)

A standardized coronally advanced flap (CAF) procedure combined with a subepithelial connective tissue graft (CTG) is performed to treat gingival recession defects. The surgical protocol includes flap elevation, graft harvesting and placement, and flap advancement and suturing.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Presence of at least one gingival recession defect classified as Cairo RT1 or Miller Class I-II with a minimum depth of 1 mm.
* Full-mouth plaque score (FMPS) and full-mouth bleeding on probing (FMBOP) \< 15%.
* Detectable cemento-enamel junction (CEJ).
* Age ≥ 18 years.
* No history of prior periodontal surgical treatment.
* Sufficient mental capacity to understand the study aims and procedures explained verbally and in writing.
* Determined to be cooperative and compliant with the clinician before, during, and after the surgical procedure.

Exclusion Criteria

* Patients younger than 18 years.
* Periodontally healthy individuals.
* Current smokers.
* History of periodontal treatment within the past 1 year.
* Use of antibiotics within the past 3 months.
* Pregnancy or breastfeeding.
* Presence of systemic diseases such as diabetes, chronic kidney failure, cancer, bleeding disorders, connective tissue diseases, or other chronic conditions; and gingival recessions classified as Cairo RT3.
* Presence of cervical caries or restorations at the defect site.
Minimum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saglik Bilimleri Universitesi

OTHER

Sponsor Role lead

Responsible Party

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Şeyma Çardakçı

asst. professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Health Sciences, Gülhane Faculty of Dentistry

Ankara, None Selected, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Seyma9319

Identifier Type: -

Identifier Source: org_study_id