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

NCT07130266 | Completed

• 2 other identifiers: E.6915620220801
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Hyaluronic acid; Periodontitis; Open Flap Debridement; Gingival recession

Outcome Measures

Primary Outcomes (1)

• Clinical attachment level (CAL)

  CAL were measured from both the buccal and palatal/lingual aspects of each tooth at six points including mesial, distal, and midpoint, and recorded in mm. CAL was measured as the distance between the base of the pocket and the enamel cement junction.

  Baseline - 3months - 6 months

Secondary Outcomes (6)

• 3D Measurements

  Baseline - 3months - 6 months

• Analysis of 2D Gingival Thickness Changes

  Baseline - 3months - 6 months

• Relative gingival recession (rGR)

  Baseline - 3months - 6 months

• Probing depth (PD)

  Baseline - 3months - 6 months

• Plaque (P)

  Baseline - 3months - 6 months

Study Arms (2)

Open Flap Debridement (OFD)

PLACEBO COMPARATOR

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

Procedure: giving an impression of the application

Open Flap Debridement (OFD)+HA

ACTIVE COMPARATOR

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.

Procedure: Procedure/Surgery: Hyaluronic acid gel application

Interventions

Procedure/Surgery: Hyaluronic acid gel application 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.

Open Flap Debridement (OFD)+HA

giving an impression of the application PROCEDURE

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

Open Flap Debridement (OFD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of periodontitis (Stage II/III);
• 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;
• a thin gingival phenotype;
• Areas with horizontal bone loss without intra-bony defects, where no additional hard and soft tissue augmentation was required
• a full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS \<20%.

You may not qualify if:

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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis; Gingival Recession

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases; Periodontal Atrophy

Study Officials

• Sadiye Gunpinar, Assoc. Prof.

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: During the surgery session, patients were block randomized, with the allocation order using a computer program (www.randomizer.org.). Group assignment was carried out by another investigator who was not involved in the treatment procedure or clinical measurements (UGE). Study groups were as follows: 1. OFD + 0.8% HA gel (n = 20, test group) 2. OFD alone (n = 20, control group).

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 19, 2025
• Study Start: May 9, 2022
• Primary Completion: June 22, 2023
• Study Completion: June 22, 2023
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Following the article publication of study protocol in a journal.
• Access Criteria: The required data can be shared by responsible person (principal investigator of the study) upon reasonable request.

Locations

TU (1)