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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Acrylic resin stent only. | Placebo Comparator | The palatal donor site covered with acrylic resin stent only. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Indirect Postoperative Pain by analgesic consumption consumption Postoperative | Pain Indirect measurement by analgesic consumption Postoperative for 7 days postoperatively | at (0-7) days |
| Wound size |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of dentistry, Cairo University | Cairo | Egypt |
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| ID | Term |
|---|---|
| D015607 | Stents |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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A Randomized Controlled Clinical Trial
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| 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. |
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| 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. |
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measure by using UNC-15 periodontal probe.
| at surgery day, day 3, day 7, day 14 and day 21 |
| patient satisfaction with the healing process | measure by using Visual analogue scale. a Visual Analog Scale (VAS) specifically designed for measuring patient satisfaction with medical care. This type of scale allows patients to express their level of satisfaction by marking a point along a continuous line, which is typically 10 cm long, representing a range from complete dissatisfaction (0) to full satisfaction (10). | completed 1 week after the surgery |
| Color match.. | measure by using Visual analogue scale. Colour match (CM) of the donor site was also assessment by using VAS scores (between 0 and 10. 0: no CM, 10: excellent CM) in comparison with adjacent and contra-lateral palatal mucosa. | on day 3, day 7, day 14, day 21, and day 42 |