Hyaluronic Acid Spray and Low-Level Laser Therapy for Wound Healing Post- Gingivectomy

Not Applicable

Recruiting

• Conditions: Gingival Enlargement

• Registration Number: NCT07034625
• Lead Sponsor: Akdeniz University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-16
• Status Verified: 2025-06
• Study First Submitted: 2025-06-14
• Study First Submitted QC: 2025-06-14
• Last Update Submitted: 2025-06-14
• Study First Posted: 2025-06-24
• Last Update Posted: 2025-06-24
• Primary Completion: 2025-07
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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
• Good oral hygiene (FMPS< %20)
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Analog Score	2 weeks	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.
Wound Healing Area Assessment	2 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Probing Pocket Depth	6 weeks	Probing pocket depth were taken at six sites/tooth and recorded using a Williams periodontal probe.
Full Mouth Bleeding Score	6 weeks	FMBS: BoP index is taken as present/absent (+/-) at six sites/teeth, full mouth bleeding score (FMBS) was then calculated as a percentage.
Gingival Index	6 weeks	The GI was measured at six sites per tooth, according to Löe \& Silness: 0- Normal gingiva; 1. Mild inflammation with slight color change, mild alteration of gingival surface structure and no bleeding on probing; 2. Moderate inflammation with edema, redness, swelling and bleeding on probing; 3. Severe inflammation with marked edema and redness, ulceration and tendency to bleed spontaneously.

Trial Locations

Locations (1)

Akdeniz University; 🇹🇷 Antalya, Konyaaltı, Turkey