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Completed

NCT Number: NCT07034625

Comparative Evaluation of Hyaluronic Acid Spray and Low-Level Laser Therapy on Wound Healing Following Gingivectomy

Gingival enlargement may impair oral hygiene, esthetics, and periodontal health, and gingivectomy is commonly performed when non-surgical treatment is insufficient. Because gingivectomy wounds heal by secondary intention, postoperative wound healing and pain control are clinically important. Low-level laser therapy and hyaluronic acid are adjunctive approaches that may support tissue healing through different biological mechanisms.

This randomized controlled clinical trial compared the effects of topical 0.04% high-molecular-weight hyaluronic acid spray and low-level laser therapy on early wound healing and postoperative pain following gingivectomy. Sixty-four systemically healthy patients requiring gingivectomy were randomly assigned to receive either hyaluronic acid spray applied twice daily for 7 days or 940-nm diode laser therapy applied on postoperative days 0, 3, 5, and 7. Wound healing was assessed using standardized clinical photographs and digital planimetric analysis at baseline and on postoperative days 3, 7, and 14. Postoperative pain was evaluated using a visual analogue scale, and periodontal parameters were recorded at baseline and 6 weeks.

The study aimed to compare these two adjunctive postoperative wound-management approaches after gingivectomy.

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Key information

Conditions

Gingival Enlargement Gingival Diseases Gingival Hyperplasia Gingival Overgrowth Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akdeniz University

Antalya, Konyaaltı, 07070, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Systemically healthy
  • Having chronic inflammatory gingival hyperplasia affecting at least 6 teeth symmetrically in the maxillary or mandibular anterior region with gingivectomy indication
  • No usage of any medication affecting periodontal tissues or causing gingival hyperplasia such as antiepileptics, immunosupresors or calcium channel blockers
  • No history of periodontitis with attachment and bone loss

Exclusion criteria

  • Having systemic disease
  • Pregnancy or breastfeeding
  • Smoking
  • Inadequate oral hygiene
  • Antibiotic usage for the past six months

Treatment and study plan

Low Level Laser Therapy

Other

A 940-nm diode laser was applied to the gingivectomy wound area on postoperative days 0, 3, 5, and 7. The laser parameters were set as follows: 3 W power output, 1.07 W/cm² power density, 2.8 cm² probe spot size, continuous wave mode, 1-mm application distance, and non-contact stationary application. The laser was applied for 120 seconds per session.

Hyaluronic Acid Spray

Other

Participants received a 0.04% high-molecular-weight hyaluronic acid spray after gingivectomy. They were instructed to apply the spray to the surgical wound area twice daily for the first 7 postoperative days.

Primary outcomes

  1. Wound Healing Percentage

    Time frame: Baseline, postoperative day 3, day 7, and day 14

    Wound healing was assessed by measuring the surgical wound surface area using standardized clinical photographs and digital planimetric analysis with ImageJ software. At baseline and on postoperative days 3, 7, and 14, the gingivectomy wound area was stained with an erythrosin-based plaque-disclosing agent to identify non-epithelialized or insufficiently keratinized areas. The healing percentage was calculated by comparing the wound area at each postoperative time point with the baseline wound area using the following formula: Healing (%) = [(Baseline wound area - Wound area at time point) / Baseline wound area] × 100.

Secondary outcomes

  1. Postoperative Pain Score (VAS)

    Time frame: Postoperative day 1, day 3, day 7, and day 14

    Postoperative pain was assessed using a 10-cm Visual Analogue Scale (VAS). Participants were asked to mark their perceived pain intensity on a horizontal line ranging from 0, indicating no pain, to 10, indicating the worst imaginable pain.

  2. Gingival Index

    Time frame: Baseline and 6 weeks postoperatively

    The GI was measured at six sites per tooth, according to Löe & Silness:

    0- Normal gingiva;

    • Mild inflammation with slight color change, mild alteration of gingival surface structure and no bleeding on probing;
    • Moderate inflammation with edema, redness, swelling and bleeding on probing;
    • Severe inflammation with marked edema and redness, ulceration and tendency to bleed spontaneously.

  3. Full Mouth Bleeding Score

    Time frame: Baseline and 6 weeks postoperatively

    FMBS: Bleeding on probing was assessed dichotomously as present or absent at six sites per tooth. The Full Mouth Bleeding Score was calculated as the percentage of bleeding-positive sites relative to the total number of examined sites.

  4. Probing Pocket Depth

    Time frame: Baseline and 6 weeks postoperatively

    Probing pocket depth was measured in millimeters from the gingival margin to the base of the sulcus or pocket at six sites per tooth using a Williams periodontal probe.

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2025
Registry last updated
Jun 11, 2026

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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