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

NCT07034625 | Completed

• 1 other identifier: AkdenizU1
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gingival Enlargement

Keywords

low-level laser therapy; gingivectomy; hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• Wound Healing Percentage

  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.

  Baseline, postoperative day 3, day 7, and day 14

Secondary Outcomes (4)

• Postoperative Pain Score (VAS)

  Postoperative day 1, day 3, day 7, and day 14

• Gingival Index

  Baseline and 6 weeks postoperatively

• Full Mouth Bleeding Score

  Baseline and 6 weeks postoperatively

• Probing Pocket Depth

  Baseline and 6 weeks postoperatively

Study Arms (2)

Low Level Laser Therapy

ACTIVE COMPARATOR

Participants in this group received low-level laser therapy after gingivectomy. A 940-nm diode laser was applied to the surgical wound area on postoperative days 0, 3, 5, and 7. The laser parameters were 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 for 120 seconds per session.

Other: Low Level Laser Therapy

Hyaluronic Acid Spray

ACTIVE COMPARATOR

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

Other: Hyaluronic Acid Spray

Interventions

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.

Low Level Laser Therapy

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.

Hyaluronic Acid Spray

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University

Antalya, Konyaaltı, 07070, Turkey (Türkiye)

Location

Related Publications (4)

• Uslu MO, Akgul S. Evaluation of the effects of photobiomodulation therapy and ozone applications after gingivectomy and gingivoplasty on postoperative pain and patients' oral health-related quality of life. Lasers Med Sci. 2020 Sep;35(7):1637-1647. doi: 10.1007/s10103-020-03037-8. Epub 2020 May 20.

  PMID: 32435906 BACKGROUND

• Reddy SP, Koduganti RR, Panthula VR, Surya Prasanna J, Gireddy H, Dasari R, Ambati M, Chandra G B. Efficacy of Low-level Laser Therapy, Hyaluronic Acid Gel, and Herbal Gel as Adjunctive Tools in Gingivectomy Wound Healing: A Randomized Comparative Clinical and Histological Study. Cureus. 2019 Dec 21;11(12):e6438. doi: 10.7759/cureus.6438.

  PMID: 31993275 BACKGROUND

• Ozcelik O, Cenk Haytac M, Kunin A, Seydaoglu G. Improved wound healing by low-level laser irradiation after gingivectomy operations: a controlled clinical pilot study. J Clin Periodontol. 2008 Mar;35(3):250-4. doi: 10.1111/j.1600-051X.2007.01194.x.

  PMID: 18269665 BACKGROUND

• Yakout BK, Kamel FR, Khadr MAEA, Heikal LAH, El-Kimary GI. Efficacy of hyaluronic acid gel and photobiomodulation therapy on wound healing after surgical gingivectomy: a randomized controlled clinical trial. BMC Oral Health. 2023 Oct 27;23(1):805. doi: 10.1186/s12903-023-03519-5.

  PMID: 37891549 BACKGROUND

MeSH Terms

Conditions

Gingival Hyperplasia

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Gingival Overgrowth; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Nezahat Arzu Kayar, PhD, DDS

  Akdeniz University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 14, 2025
• First Posted: June 24, 2025
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: June 11, 2026

Record last verified: 2025-06

Locations

TU (1)