Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521333
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-21
Brief Title:
Resveratrol-Based Gel Application in a Palatal Wound Following Free Gingival Graft Surgery
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aim of the study to compare the effect of Resveratrol- Based gel versus 02 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 012 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 0001 adrenaline A partial thickness graft consisting of epithelium and a thin layer of connective tissue will be harvested with proper thickness between 10 and 15 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 02 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 02 HA 02 hyaluronic acid gel Gengigel The 02 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
Additionally 012 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 0001 adrenaline A partial thickness graft consisting of epithelium and a thin layer of connective tissue will be harvested with proper thickness between 10 and 15 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 02 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 02 HA 02 hyaluronic acid gel Gengigel The 02 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None