Clinical Effectiveness of Polymethoxy Flavones Solid Dispersion as a Dressing Material for Palatal Grafts Donor Sites

Not Applicable

Not yet recruiting

• Conditions: Soft Tissue Infections; Gingival Recession
• Interventions: Drug: hydroxylate flavones solid dispersion application; Other: Placebo

• Registration Number: NCT05814003
• Lead Sponsor: Assiut University

Brief Summary

Free gingival grafting surgeries require palatal grafts harvesting from the patient own palates . The donor sites pain , infection and retarded healing by secondary intension are the complication .

Detailed Description

After the preparation and characterization of the solid dispersion of hydroxylated methoxy flavones, free gingival grafting surgeries require palatal grafts harvesting from the patient own palates . The donor sites pain , infection and retarded healing by secondary intension are the complications ; the aim of the study is to assess the analgesic , anti inflammatory effects of hydroxylated methoxy flavones.

Study Timeline

• Study First Submitted: 2022-10-10
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-13
• Last Update Submitted: 2023-04-13
• Study First Posted: 2023-04-14
• Last Update Posted: 2023-04-14
• Study Start: 2023-04-20
• Primary Completion: 2023-05-20
• Study Completion: 2023-05-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• insufficient zone of keratinized gingiva recession of the gingiva non smokers free from systemic disorders

Exclusion Criteria

• smokers insufficient palatal donor sits un realistic expectations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hydroxylate flavones	hydroxylate flavones solid dispersion application	flavonoids mainly derived from citrus peel and have numerous strong biological activities, including anti-inflammatory , antioxidant , antimicrobial , and anticancer
hydroxylate flavones	Placebo	flavonoids mainly derived from citrus peel and have numerous strong biological activities, including anti-inflammatory , antioxidant , antimicrobial , and anticancer
alveogyl	hydroxylate flavones solid dispersion application	ALVOGYL is a brown fibrous paste which contains per 100 g the following active ingredients : 25.70 g of butamben, 15.80 g of iodoform and 13.70 g of eugenol.
alveogyl	Placebo	ALVOGYL is a brown fibrous paste which contains per 100 g the following active ingredients : 25.70 g of butamben, 15.80 g of iodoform and 13.70 g of eugenol.
stent	hydroxylate flavones solid dispersion application	acrylic resin material used to cover denuded soft tissues

Primary Outcome Measures

Name	Time	Method
post operative pain (VAS scale)	first day postoperative to 30 days (days)	VAS scale from 0 no pain to 10 excruciating pain (healing)

Secondary Outcome Measures

Name	Time	Method
Number of analgesic and anti inflammatory pills consumed	first day postoperative to 30 days (days)	Minimizing the pain and inflammation during healing process post operative swelling

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt