Active Oxygen Gel Versus Hyaluronic Acid Gel for Palatal Wound Healing After Free Gingival Graft

NCT07683351 | Recruiting

• 2 other identifiers: 919/2024suez canal university
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled clinical trial aims to evaluate and compare the effectiveness of different palatal dressing materials on wound healing following free gingival graft harvesting. Thirty systemically healthy patients with mucogingival defects requiring free gingival graft procedures will be enrolled from the outpatient clinic of the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Suez Canal University. Patients will be randomly allocated into three equal groups (10 patients each). Group A (control) will receive a gelatin sponge with flowable composite on the donor site. Group B will receive hyaluronic acid gel covered with a gelatin sponge and flowable composite. Group C will receive active oxygen gel covered with a gelatin sponge and flowable composite. Postoperative outcomes will be assessed in terms of pain (visual analog scale), analgesic consumption, clinical wound healing (Landry healing index), complete wound re-epithelialization (hydrogen peroxide test), dimensional changes of the wound, and occurrence of complications. Evaluations will be performed at baseline and during follow-up visits up to four weeks postoperatively. The study aims to determine which dressing material provides better postoperative comfort and enhances palatal wound healing after free gingival graft procedures.

Conditions

Palatal Wound Healing; Mucogingival Defects; Free Gingival Graft Donor Site

Keywords

free gingival graft; palatal wound healing; hyaluronic acid gel; active oxygen gel

Outcome Measures

Primary Outcomes (1)

• Wound healing (Landry Healing Index)

  Assessment of palatal wound healing using the Landry Healing Index, which uses a score ranging from 1 to 5, with higher scores indicating better wound healing. The assessment includes tissue color, response to palpation, bleeding, granulation tissue, incision margin, and suppuration.

  1 week, 2 weeks, 3 weeks and 4 weeks postoperatively

Secondary Outcomes (3)

• Postoperative pain (VAS score)

  Daily for the first postoperative week (Day 1 to Day 7)

• Complete epithelialization (Hydrogen peroxide test)

  1 week, 2 weeks, 3 weeks and 4 weeks postoperatively

• Two-dimensional wound area reduction

  Baseline, 1 week, 2 weeks, 3 weeks and 4 weeks postoperatively

Study Arms (3)

Control group

OTHER

Participants will receive a gelatin sponge covered with flowable composite applied to the palatal donor site after free gingival graft harvesting as the control dressing for wound management.

Procedure: Gelatin sponge with flowable composite

Hyaluronic acid group

EXPERIMENTAL

Participants will receive hyaluronic acid gel applied to the palatal donor site and covered with a gelatin sponge and flowable composite dressing after free gingival graft harvesting.

Drug: Hyaluronic Acid gel

Active oxygen group (Blue®m)

EXPERIMENTAL

Participants will receive active oxygen gel applied to the palatal donor site and covered with a gelatin sponge and flowable composite dressing after free gingival graft harvesting.

Drug: Active oxygen gel

Interventions

Hyaluronic Acid gel DRUG

Hyaluronic acid gel applied to the palatal donor site and covered with a gelatin sponge and flowable composite dressing after free gingival graft harvesting to enhance wound healing.

Hyaluronic acid group

Active oxygen gel DRUG

Active oxygen gel applied to the palatal donor site and covered with a gelatin sponge and flowable composite dressing after free gingival graft harvesting to enhance wound healing.

Active oxygen group (Blue®m)

Gelatin sponge with flowable composite PROCEDURE

Gelatin sponge covered with flowable composite applied to the palatal donor site after free gingival graft harvesting as the standard control dressing for wound management

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Systemically healthy patients Age between 18 and 60 years Patients with mucogingival defects requiring free gingival graft Adequate palatal thickness (\>3 mm) Cooperative and motivated patients Good oral hygiene compliance

You may not qualify if:

• Systemic diseases that contraindicate surgical procedures Smokers Pregnant or lactating females Immunocompromised patients Patients undergoing chemotherapy or radiotherapy Poor oral hygiene or non-compliant patients Palatal infection

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Faculty of Dentistry, Suez Canal University

Ismailia, Ismailia Governorate, Egypt

RECRUITING

MeSH Terms

Interventions

flowable hybrid composite

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned into three parallel groups receiving different palatal dressing materials after free gingival graft harvesting

Study Record Dates

• First Submitted: June 27, 2026
• First Posted: July 6, 2026
• Study Start: August 27, 2025
• Primary Completion (Estimated): August 27, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: July 22, 2026

Record last verified: 2026-06

Locations

EG (1)