NCT05787912

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 15, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 28, 2023

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

1 year

First QC Date

March 15, 2023

Last Update Submit

March 15, 2023

Conditions

Gingival Enlargement

Keywords

Surgical gingivectomyHyaluronic acidPhotobiomodulation

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Photobiomodulation

EXPERIMENTAL
Device: Photobiomodulation

Hyaluronic acid gel after photobiomodulation

EXPERIMENTAL
Other: Hyaluronic acid after photobiomodulation

Interventions

PhotobiomodulationDEVICE

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

Photobiomodulation
Hyaluronic acid after photobiomodulationOTHER

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.

Hyaluronic acid gel after photobiomodulation

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location

Related Publications (1)

  • Yakout BK, Kamel FR, Khadr MAEA, Heikal LAH, El-Kimary GI. Efficacy of hyaluronic acid gel and photobiomodulation therapy on wound healing after surgical gingivectomy: a randomized controlled clinical trial. BMC Oral Health. 2023 Oct 27;23(1):805. doi: 10.1186/s12903-023-03519-5.

    PMID: 37891549DERIVED

MeSH Terms

Conditions

Gingival Hyperplasia

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Gingival OvergrowthGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Basma K Yacout, BDS

    Alexandria University

    PRINCIPAL INVESTIGATOR

  • Fatma R Kamel, PhD

    Alexandria University

    STUDY DIRECTOR

  • Maha A Abou Khadr, PhD

    Alexandria University

    STUDY DIRECTOR

  • Lamia A Heikal, PhD

    Faculty of Pharmacy, Alexandria University

    STUDY DIRECTOR

  • Gillan I El-Kimary, PhD

    Alexandria University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Periodontology

Study Record Dates

First Submitted

March 15, 2023

First Posted

March 28, 2023

Study Start

February 1, 2022

Primary Completion

February 1, 2023

Study Completion

February 10, 2023

Last Updated

March 28, 2023

Record last verified: 2023-03

Locations

EG(1)