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CompletedNCT05787912Updated Mar 28, 2023

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

An interventional study of Photobiomodulation and Hyaluronic acid after photobiomodulation in Gingival Enlargement, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-03-28.

Sponsored by Alexandria University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Feb 2022, registered Mar 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Gingival Enlargement

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Keywords

  • Surgical gingivectomy
  • Hyaluronic acid
  • Photobiomodulation
03

In context

Gingival Overgrowth

22 studies on the registry are indexed under Gingival Overgrowth; 2 are open to participants now.

This study's enrollment of 26 is below the median of 30 across 20 interventional studies indexed under Gingival Overgrowth.

Browse Gingival Overgrowth studies →

Lead sponsor

Alexandria University is the lead sponsor of 569 studies on the registry; 125 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Photobiomodulation

    Device: Photobiomodulation

  • Experimental
    Hyaluronic acid gel after photobiomodulation

    Other: Hyaluronic acid after photobiomodulation

Interventions

  • DevicePhotobiomodulation

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

  • OtherHyaluronic 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: up to 21 days

  2. 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.

    Time frame: up to 21 days

07

Study locations

1 site
  • Faculty of Dentistry, Alexandria University
    Alexandria, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05787912
Lead sponsor
Alexandria University
Responsible party
Basma Khalil (Resident of Periodontology, Alexandria University) — Principal investigator
First posted
Mar 28, 2023
Start date
Feb 1, 2022
Primary completion
Feb 1, 2023
Completion
Feb 10, 2023
Last update
Mar 28, 2023

Study contacts

Basma K Yacout, BDS
principal investigator · Alexandria University
Fatma R Kamel, PhD
study director · Alexandria University
Maha A Abou Khadr, PhD
study director · Alexandria University
Lamia A Heikal, PhD
study director · Faculty of Pharmacy, Alexandria University
Gillan I El-Kimary, PhD
study chair · Alexandria University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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