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Completed

NCT Number: NCT07130266

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

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.

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Key information

Conditions

Hyaluronic Acid Gingival Diseases Gingival Phenotype Gingival Recession Mouth Diseases Open Flap Debridement Periodontal Atrophy Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakif University

Istanbul, 34000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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%.

Exclusion criteria

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

Treatment and study plan

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.

giving an impression of the application

Procedure

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

Primary outcomes

  1. Clinical attachment level (CAL)

    Time frame: Baseline - 3months - 6 months

    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.

Secondary outcomes

  1. 3D Measurements

    Time frame: 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.

  2. Analysis of 2D Gingival Thickness Changes

    Time frame: 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.

  3. Relative gingival recession (rGR)

    Time frame: 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).

  4. Probing depth (PD)

    Time frame: Baseline - 3months - 6 months

    Defined as the distance from the base of the periodontal pocket to the marginal gingiva

  5. Plaque (P)

    Time frame: 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.

  6. Bleeding on probing (BoP)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

Evaluation of the Clinical and Volumetric Effectiveness of 0.8% Hyaluronic Acid Gel Adjunct to Open-Flap Surgery in Periodontitis Patients With Thin Gingival Phenotype

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 19, 2025
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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