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

Bezmialem Vakif University

Status: Completed

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

Treatments: Procedure: Procedure/Surgery: Hyaluronic acid gel application; Procedure: giving an impression of the application

Study type: Interventional

Funder types: Other

Identifiers

NCT07130266

E.69156

20220801 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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37 participants in 2 patient groups, including a placebo group

Open Flap Debridement (OFD)

Placebo Comparator group

Description:

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

Treatment:

Procedure: giving an impression of the application

Open Flap Debridement (OFD)+HA

Active Comparator group

Description:

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.

Treatment:

Procedure: Procedure/Surgery: Hyaluronic acid gel application