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

NCT ID: NCT06521333

Last Updated: 2024-07-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-14
• Study Completion Date: 2025-11-01

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.

Detailed Description

Treatment Protocol Presurgical Phase Initial phase will involve comprehensive periodontal treatment, including full mouth supragingival scaling, subgingival debridement using ultrasonic devices and Gracey curettes, and polishing one month prior to surgery. Patients will receive detailed instructions on mechanical plaque control techniques, such as the brushing technique with a soft toothbrush, and the importance of maintaining oral health.

Additionally, 0.12% Chlorhexidine HCL mouthwash will be prescribed for chemical plaque control, to be used twice daily for 2 weeks.

Surgical procedure Step 1: Preparing the recipient site. Step 2: Harvesting the free gingival graft from palate. The Free Gingival Graft (FGG) will be harvested from the palate using a standardized technique. The palatal sites will be anaesthetized with a solution of 2% lidocaine and 0.001% adrenaline. A partial thickness graft, consisting of epithelium and a thin layer of connective tissue, will be harvested with proper thickness between 1.0 and 1.5 mm for optimal graft survival.

Step 3: Placement of free gingival graft on the recipient beds Step 4: Management of the Palatal Wound

Denuded palatal area will be protected using one of the following options:

1. Resveratrol- Based gel covered with acrylic resin stent (test group I).

2. Hyaluronic acid (HA) gel 0.2% with acrylic resin stent (test group II)

3. Acrylic resin stent (control group III) Test Group I Resveratrol- Based gel 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. Test Group II (0.2% HA) 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.

Group III (Control Group) 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.

Step 5: Postoperative care The postoperative instructions will be specified to avoid using a toothbrush or floss in the vicinity of the surgical sites. During the first week, patients will be instructed to limit their food intake to soft foods and to avoid any mechanical trauma.

Patient evaluation of post-operative morbidity and aesthetics will be conducted during appointments on days 3, 7, 14, 21, and 42 following the evaluation.

Conditions

Mucogingival Defects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Resveratrol-Based gel

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.

Group Type: EXPERIMENTAL

Resveratrol-Based gel

Intervention Type: 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.

Hyaluronic acid gel 0.2%

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.

Group Type: ACTIVE_COMPARATOR

Hyaluronic acid gel 0.2%

Intervention Type: 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.

Acrylic resin stent only.

The palatal donor site covered with acrylic resin stent only.

Group Type: PLACEBO_COMPARATOR

Stent

Intervention Type: 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.

Interventions

Resveratrol-Based gel

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.

Intervention Type: DRUG

Hyaluronic acid gel 0.2%

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.

Intervention Type: DRUG

Stent

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.

Intervention Type: DEVICE

Other Intervention Names

Gengigel

Eligibility Criteria

Inclusion Criteria

1. Patient over 18 years of age

2. Systemically healthy

3. Plaque index (PI) and gingival index (GI) less than 15% (Silness & Löe)

4. Patients with Mucogingival defects scheduled for free gingival graft

Exclusion Criteria

1. Pregnancy or breastfeeding.

2. Occlusal trauma at site of graft.

3. Severe gagging reflex

4. Smokers.

5. Patients allergic to the used materials.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Liza saleh kasem ALhakam

Dentist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liza S ALhakam

Role: PRINCIPAL_INVESTIGATOR

master student.

Manar T El-Zanaty, PhD

Role: STUDY_CHAIR

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

Enji A Mahmoud, Professor

Role: STUDY_DIRECTOR

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

Locations

Faculty of dentistry, Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Liza S ALhakam, BDS

Role: CONTACT

liza.alhakam@dentistry.cu.edu.eg

01555325810

Manar T El-Zanaty, PhD

Role: CONTACT

manar.elzanaty@dentistry.cu.edu.eg

01001775660

Other Identifiers

19424

Identifier Type: -

Identifier Source: org_study_id