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

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

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

Conditions
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Gingival Enlargement

Intervention / Treatment
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* Device: Photobiomodulation
* Other: Hyaluronic acid after photobiomodulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Photobiomodulation<br> | Device: Photobiomodulation<br>* The surgical sites were irradiated with a diode laser (980 nm, 0.2W) only.<br>|
| Experimental: Hyaluronic acid gel after photobiomodulation<br> | Other: Hyaluronic acid after photobiomodulation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical gingivectomy, Hyaluronic acid, Photobiomodulation