Resveratrol-Based Gel Application in a Palatal Wound Following Free Gingival Graft Surgery

NCT06521333 | Completed DMC

• 1 other identifier: 19424
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the study to compare the effect of Resveratrol- Based gel versus 0.2% Hyaluronic acid gel applied to the palatal donor site and acrylic resin stent only in post-operative pain reduction after free gingival graft harvesting.

Conditions

Mucogingival Defects

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain

  direct measure by using Visual Analog Scale (VAS) pain scores (ranging from 0 to 10, where 0 indicates no pain 1: minimal pain and 10 signifies severe pain) will be recorded daily for one week as the pain is expected to reach its maximum level during the initial healing phase (0-3 days)

  at (0--7 days)

Secondary Outcomes (4)

• Indirect Postoperative Pain by analgesic consumption consumption Postoperative

  at (0-7) days

• Wound size

  at surgery day, day 3, day 7, day 14 and day 21

• patient satisfaction with the healing process

  completed 1 week after the surgery

• Color match..

  on day 3, day 7, day 14, day 21, and day 42

Study Arms (3)

Resveratrol-Based gel

EXPERIMENTAL

The Resveratrol-Based gel will be applied using a sterile plastic syringe, and the palatal wound will be immediately covered by an acrylic resin stent. Three days postoperatively, the patients will be recalled, the stent will be removed for evaluation and the Resveratrol gel will be reapplied.

Drug: Resveratrol-Based gel

Hyaluronic acid gel 0.2%

ACTIVE COMPARATOR

0.2% hyaluronic acid gel (Gengigel®) The 0.2% Hyaluronic acid gel will be applied using a sterile plastic syringe, and the palatal wound will be covered by an acrylic resin stent. Three days postoperatively, the patients will be recalled, the stent will be removed for evaluation, and the Hyaluronic acid gel will be reapplied.

Drug: Hyaluronic acid gel 0.2%

Acrylic resin stent only.

PLACEBO COMPARATOR

The palatal donor site covered with acrylic resin stent only.

Device: Stent

Interventions

Resveratrol-Based gel DRUG

The Resveratrol-Based gel will be applied using a sterile plastic syringe, and the palatal wound will be immediately covered by an acrylic resin stent. Three days postoperatively, the patients will be recalled, the stent will be removed for evaluation and the Resveratrol gel will be reapplied.

Resveratrol-Based gel

Hyaluronic acid gel 0.2% DRUG

The 0.2% Hyaluronic acid gel will be applied using a sterile plastic syringe, and the palatal wound will be covered by an acrylic resin stent. Three days postoperatively, the patients will be recalled, the stent will be removed for evaluation, and the Hyaluronic acid gel will be reapplied.

Also known as: Gengigel

Hyaluronic acid gel 0.2%

Stent DEVICE

The palatal wound will be immediately covered by acrylic resin stent three days postoperatively, the patients will be recalled, and the stent will be removed for evaluating the healing of the palatal wound and then recover with stent.

Acrylic resin stent only.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient over 18 years of age
• Systemically healthy
• Plaque index (PI) and gingival index (GI) less than 15% (Silness \& Löe)
• Patients with Mucogingival defects scheduled for free gingival graft

You may not qualify if:

• Pregnancy or breastfeeding.
• Occlusal trauma at site of graft.
• Severe gagging reflex
• Smokers.
• Patients allergic to the used materials.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry, Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

Stents

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Liza S ALhakam

  master student.

  PRINCIPAL INVESTIGATOR

• Manar T El-Zanaty, PhD

  Lecturer of oral medicine and Periodontology, Faculty of Dentistry, Cairo University.

  STUDY CHAIR

• Enji A Mahmoud, Professor

  Professor of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist

Model Details: A Randomized Controlled Clinical Trial

Study Record Dates

• First Submitted: July 21, 2024
• First Posted: July 25, 2024
• Study Start: May 14, 2024
• Primary Completion: December 30, 2025
• Study Completion: January 1, 2026
• Last Updated: March 17, 2026

Record last verified: 2024-07

Locations

EG (1)