Efficacy of Hyaluronic Acid Gel and Photobiomodulation on Wound Healing After Surgical Gingivectomy

Sponsor

Alexandria University (Other)

Overall Status

Completed

CT.gov ID

NCT05787912

Collaborator

(none)

Enrollment

Location

Arms

12.3

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study was to evaluate the effect of hyaluronic acid gel after photobiomodulation on the healing of surgical gingivectomy sites

Condition or Disease	Intervention/Treatment	Phase
Gingival Enlargement	Device: Photobiomodulation Other: Hyaluronic acid after photobiomodulation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Efficacy of Hyaluronic Acid Gel and Photobiomodulation on Wound Healing After Surgical Gingivectomy: a Randomized Controlled Clinical Trial

Actual Study Start Date :

Feb 1, 2022

Actual Primary Completion Date :

Feb 1, 2023

Actual Study Completion Date :

Feb 10, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Photobiomodulation	Device: Photobiomodulation The surgical sites were irradiated with a diode laser (980 nm, 0.2W) only.
Experimental: Hyaluronic acid gel after photobiomodulation	Other: Hyaluronic acid after photobiomodulation The surgical sites after gingivectomy were irradiated with a diode laser (980 nm, 0.2W) then covered by 2% Hyaluronic acid gel loaded in a special appliance for each patient.

Arm

Intervention/Treatment

Experimental: Photobiomodulation

Device: Photobiomodulation

The surgical sites were irradiated with a diode laser (980 nm, 0.2W) only.

Experimental: Hyaluronic acid gel after photobiomodulation

Other: Hyaluronic acid after photobiomodulation

The surgical sites after gingivectomy were irradiated with a diode laser (980 nm, 0.2W) then covered by 2% Hyaluronic acid gel loaded in a special appliance for each patient.

Outcome Measures

Primary Outcome Measures

Wound healing [up to 21 days]
Assessed using Landry's healing index which grades the wound on a scale of 1 (poor) to 5 (excellent) Very poor (1): ≥50% of gingiva red, bleeding on palpation, Granulation tissue present, Non-epithelialized incision margin with loss of epithelium beyond the margin. Poor (2): ≥50% of gingiva red, bleeding on palpation, Granulation tissue present, Non-epithelialized incision margin with exposed connective tissue Good (3): ≥25% and<50% of gingiva red, No bleeding on palpation, no granulation tissue, No exposed connective tissue on the incision margin Very good (4): <25% of gingiva red, No bleeding on palpation, no granulation tissue, No exposed connective tissue on the incision margin Excellent (5): All tissues are pink, No bleeding on palpation, no granulation tissue, No exposed connective tissue on the incision margin
Perceived pain [up to 21 days]
This was assessed using Visual Analogue Scale (VAS). Patients were instructed to chart their perceptions of pain using VAS ranging from 0-10; where 0 represents no pain/burning sensation and 10 represents severe pain/burning sensation.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Chronic inflammatory gingival enlargement grade 2 and 3 according to the gingival overgrowth index by Miller and Damn.
Adequate amount of keratinized tissue.
Attachment loss= 0
Well educated patients as post-operative instructions need to be followed precisely.

Exclusion Criteria:

Patients with history of smoking
Pregnant women
Patients with bad oral hygiene
Patients who have any known systemic disease that interfere with performance of surgical gingivectomy or periodontal wound healing
Patients who have any previous adverse reactions to the products (or similar products) used in this study