Adjunctive 0.8% Hyaluronic Acid Gel in Open-Flap Surgery for Thin Gingival Phenotype in Patients With Periodontitis

NCT ID: NCT07130266

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-09
• Study Completion Date: 2023-06-22

Brief Summary

The aim of this study is to evaluate the clinical effectiveness of 0.8% hyaluronic acid (HA) gel as an adjunct to open flap debridement (OFD) in periodontitis patients with a thin gingival phenotype.

The primary research question is:

Does the adjunctive use of 0.8% HA gel reduce gingival recession and improve clinical parameters? To answer this, researchers will compare the adjunctive use of 0.8% HA gel to physiological saline in combination with OFD, assessing their effects on clinical outcomes and gingival recession in patients with a thin gingival phenotype.

Participants will:

• Receive 0.8% HA gel application during OFD surgery and a second application at 4 weeks postoperatively.
• Attend follow-up visits at 1, 3, and 6 months after surgery for clinical assessments and measurements.

Detailed Description

A total of 40 patients were enrolled in the study and randomly assigned to two groups: (a) OFD + 0.8% HA gel (n = 20, test group) and (b) OFD alone (n = 20, control group). Clinical parameters including plaque (P), bleeding on probing (BoP), probing pocket depth (PPD), and clinical attachment level (CAL) were recorded at baseline. Following initial periodontal therapy, sites with PPD ≥ 5 mm and horizontal bone loss, were identified in patients with a thin gingival phenotype, determined using color-coded gingival probes. Intraoral digital scans were taken, and relative gingival recession (rGR) was recorded immediately before surgery.

During OFD, the test group received adjunctive 0.8% HA gel, while the control group received physiological saline. In the test group, HA gel application was repeated at 4 weeks postoperatively. Changes in soft tissue volume (mm³) and thickness (mm) were measured using specialized computer software. Follow-up evaluations were performed at 3 and 6 months post-treatment.

Conditions

Hyaluronic Acid; Open Flap Debridement; Periodontitis; Gingival Phenotype; Gingival Recession

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Open Flap Debridement (OFD)

Open flap debridement was carried out, and the surgical site was irrigated with physiological saline in a manner consistent with the HA gel application protocol in the test group. A second application of physiological saline to the sulcus area was performed four weeks postoperatively

Group Type: PLACEBO_COMPARATOR

giving an impression of the application

Intervention Type: PROCEDURE

In the control group, instead of HA gel, the area was irrigated with physiological saline solution.

Open Flap Debridement (OFD)+HA

Open flap debridement was carried out, and 1 ml of 0.8% HA gel was applied to the root surfaces of the affected teeth, bone, and the inner surface of the flap in the surgical area for 2 minutes. HA gel application was repeated at four weeks postoperatively.

Group Type: ACTIVE_COMPARATOR

Procedure/Surgery: Hyaluronic acid gel application

Intervention Type: PROCEDURE

After root surface cleaning and infected cement removal, 0.8% HA gel was applied to the root surface, bone, and inner surface of the flap and left for 2 minutes.

Interventions

Procedure/Surgery: Hyaluronic acid gel application

After root surface cleaning and infected cement removal, 0.8% HA gel was applied to the root surface, bone, and inner surface of the flap and left for 2 minutes.

Intervention Type: PROCEDURE

giving an impression of the application

In the control group, instead of HA gel, the area was irrigated with physiological saline solution.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of periodontitis (Stage II/III);

2. Presence of horizontal bone loss with at least three adjacent teeth, each exhibiting a probing depth ≥ 5mm and a keratinized tissue width ≥ 2mm on single-rooted teeth;

3. a thin gingival phenotype;

4. Areas with horizontal bone loss without intra-bony defects, where no additional hard and soft tissue augmentation was required

5. a full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS <20%.

Exclusion Criteria

• Systemic diseases
• Smokers
• Pregnant or lactating women
• Those who received periodontal treatment within the last 6 months

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sadiye Gunpinar, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Bezmialem Vakif University

Locations

Bezmialem Vakif University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

20220801

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

E.69156

Identifier Type: -

Identifier Source: org_study_id