Comparative Evaluation of Hyaluronic Acid Spray and Low-Level Laser Therapy on Wound Healing Following Gingivectomy: A Randomized, Noninferiority Trial

NCT07034625 | Completed

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

Brief Summary

Gingival enlargement is a common condition caused by increased cell numbers, leading to connective tissue expansion. It can hinder plaque control and cause aesthetic and functional problems, often requiring surgical intervention. Gingivectomy is the primary procedure for treating gingival enlargement, ensuring periodontal health. Postoperative low-level laser therapy (LLLT) may reduce inflammation, relieve pain, and accelerate tissue regeneration. Similarly, hyaluronic acid (HA) stimulates cell proliferation, migration, and differentiation, promoting wound healing. This study aimed to compare the effects of LLLT and HA spray on early wound healing after gingivectomy.

Conditions

Gingival Enlargement

Keywords

low-level laser therapy; gingivectomy; hyaluronic acid

Outcome Measures

Primary Outcomes (2)

• Visual Analog Score

  The Visual Analogue Scale (VAS) is the most common method used to translate values that we cannot measure numerically into numerical form and to measure the severity of acute pain; therefore, the pain felt by the patients in the postoperative period was evaluated using VAS. Patients were given a chart in which a line with a length of 10 cm and a number between 1 and 10 was written on each cm distance and the definitions of the parameter to be evaluated were written and the patient was asked to indicate where his/her condition was appropriate on this line by pointing. On the given scale, 'no pain' was written on '0' end and 'worst pain' was written on the '10' (0: No pain 1-3: Slight pain 3.1-6: Moderate pain 6.1-10: Severe pain), and the patient was asked to mark his/her current pain condition on this line on the 1st day, 3rd day, 7th day and 14th day after the operation.

  2 weeks

• Wound Healing Area Assessment

  At baseline, 3rd day, 7th day and 14th day, the surgical gingivectomy area was disclosed by a erythrosin and gluten-free plaque-disclosing solution to visualize the areas in which the gingival epithelium is absent, abraded or lacking sufficient keratinization and to distinguish these areas from normal gingiva.

  2 weeks

Secondary Outcomes (3)

• Gingival Index

  6 weeks

• Full Mouth Bleeding Score

  6 weeks

• Probing Pocket Depth

  6 weeks

Study Arms (2)

Low level laser therapy

ACTIVE COMPARATOR

After gingivectomy surgery, 940 nm wavelength diode laser was applied to the wound area on the surgery day, 3rd, 5th and 7th days postoperatively. The power of the laser was set to 3W, power density 1.07 W/cm2, probe spot size 2.8 cm2, application mode continuous wave, application distance 1mm and application type stable.

Other: Low Level Laser Therapy

Hyaluronic Acid Spray

ACTIVE COMPARATOR

After gingivectomy surgery, patients were given a high molecular weight hyaluronic acid spray and instructions for use were explained. Accordingly, the patients applied the spray to the wound area twice a day for the first 7 days.

Other: Gengigel Spray

Interventions

Low Level Laser Therapy OTHER

940 nm wavelength diode laser was applied to the wound area on the surgery day, 3rd, 5th and 7th days postoperatively. The power of the laser was set to 3W, power density 1.07 W/cm2, probe spot size 2.8 cm2, application mode continuous wave, application distance 1mm and application type stable.

Low level laser therapy

Gengigel Spray OTHER

Patients were given a high molecular weight hyaluronic acid spray and instructions for use were explained. Accordingly, the patients applied the spray to the wound area twice a day for the first 7 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: December 5, 2025

Record last verified: 2025-06

Locations

TU (1)