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Completed

NCT Number: NCT05787912

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

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

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Key information

Conditions

Gingival Enlargement Gingival Diseases Gingival Hyperplasia Gingival Overgrowth Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Photobiomodulation

Device

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

Hyaluronic acid after photobiomodulation

Other

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.

Primary outcomes

  1. Wound healing

    Time frame: 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

  2. Perceived pain

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 28, 2023
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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