Clinical trial NCT06521333: Resveratrol-Based Gel Application in a Palatal Wound Following Free Gingival Graft Surgery
Official title: Efficacy of Resveratrol-Based Gel Versus Hyaluronic Acid Gel as a Palatal Wound Dressing Materials on Postoperative Pain Following Free Gingival Graft Surgery: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mucogingival Defects
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized Controlled Clinical Trial
Primary purpose: TREATMENT

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.

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 \&amp; 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.

Primary outcomes:
measure: Postoperative Pain
timeFrame: at (0--7 days)
Secondary outcomes:
measure: Indirect Postoperative Pain by analgesic consumption consumption Postoperative
timeFrame: at (0-7) days
measure: Wound size
timeFrame: at surgery day, day 3, day 7, day 14 and day 21
measure: patient satisfaction with the healing process
timeFrame: completed 1 week after the surgery
measure: Color match..
timeFrame: on day 3, day 7, day 14, day 21, and day 42
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry, Cairo University
Study officials:
affiliation: master student.
name: Liza S ALhakam
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer of oral medicine and Periodontology, Faculty of Dentistry, Cairo University.
name: Manar T El-Zanaty, PhD
role: STUDY_CHAIR
affiliation: Professor of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University.
name: Enji A Mahmoud, Professor
role: STUDY_DIRECTOR
References: