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

Not Applicable

Completed

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

• Registration Number: NCT07130266
• Lead Sponsor: Bezmialem Vakif University

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 applied during OFD surgery and again at 4 weeks postoperatively.

* Attend follow-up visits at 1, 3, and 6 months post-surgery for clinical evaluations 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 Hu-Friedy 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.

Study Timeline

• Study Start: 2022-05-09
• Primary Completion: 2023-06-22
• Study Completion: 2023-06-22
• Status Verified: 2025-08
• Study First Submitted: 2025-08-12
• Study First Submitted QC: 2025-08-12
• Last Update Submitted: 2025-08-12
• Study First Posted: 2025-08-19
• Last Update Posted: 2025-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical attachment level (CAL)	Baseline - 3months - 6 months	CAL) were measured from both the buccal and palatinal/lingual sides of each tooth at six points including mesial, distal, and midpoint, and recorded in mm. distance between the base of the pocket and the enamel cement junction

Secondary Outcome Measures

Name	Time	Method
Probing depth (PD)	Baseline - 3months - 6 months	as the measurement of the length between the bottom of the periodontal pocket to marginal gingiva
Analysis of 2D Gingival Thickness Changes	Baseline - 3months - 6 months	The change in gingival thickness at all time points was calculated using standard reference points on the previously superimposed models. Gingival thickness change was measured in 2D at these points, and repeated for both buccal and palatal/lingual regions.
relative gingival recession (rGR)	Baseline - 3months - 6 months	The distance between the horizontal reference point on the acrylic stent and the marginal gingiva at the surgical site was measured and recorded as relative gingival recession (rGR).
3D Measurements	Baseline - 3months - 6 months	The median tooth in the area of three adjacent teeth undergoing surgery was chosen for analysis, as it included the interproximal papilla regions of the adjacent teeth treated with periodontal surgery. Data from the 3rd and 6th months intraoral digital scans were extracted separately from the baseline, and the region for volumetric analysis was divided into three equal parts: mesial, distal, and middle. The interproximal and middle regions were evaluated separately, and the volumetric changes over time were calculated in mm³ using the program.
Plaque (P)	Baseline - 3months - 6 months	presence of plaque (P) was evaluated as present/absent at six points of each tooth and recorded as percentages. Surgical site measurements were repeated at 3-and 6 months.
Bleeding on probing (BoP)	Baseline - 3months - 6 months	Bleeding on probing (BoP) was evaluated as present/absent at six points of each tooth and recorded as percentages. Surgical site measurements were repeated at 3-and 6 months.

Trial Locations

Locations (1)

Bezmialem Vakıf University; 🇹🇷 Istanbul, Turkey