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

Gingival Enlargement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05787912
• Other study ID #: #1
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: February 10, 2023

Study information

• Verified date: March 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: February 10, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingival Enlargement
• Gingival Hyperplasia
• Gingival Hypertrophy
• Gingival Overgrowth

Intervention

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

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.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healing	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	up to 21 days
Primary	Perceived pain	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.	up to 21 days