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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Photobiomodulation

Hyaluronic acid after photobiomodulation

About this trial

This is an interventional treatment trial for Gingival Enlargement focused on measuring Surgical gingivectomy, Hyaluronic acid, Photobiomodulation

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Faculty of Dentistry, Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Photobiomodulation

Hyaluronic acid gel after photobiomodulation

Arm Description

Outcomes

Primary Outcome Measures

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

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05787912

First Posted

March 15, 2023

Last Updated

March 15, 2023

Sponsor

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT05787912

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

February 1, 2022 (Actual)

Primary Completion Date

February 1, 2023 (Actual)

Study Completion Date

February 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gingival Enlargement

Keywords

Surgical gingivectomy, Hyaluronic acid, Photobiomodulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Photobiomodulation

Arm Type

Experimental

Arm Title

Hyaluronic acid gel after photobiomodulation

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Photobiomodulation

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Hyaluronic acid after photobiomodulation

Intervention Description

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 Outcome Measure Information:

Title

Wound healing

Description

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

Title

Perceived pain

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials: