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

NCT05814003 — Not applicable, Unknown, 30 participants, Assiut University

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The Clinical Effectiveness of Hydroxylated Polymethoxy Flavones Solid Dispersion as a Dressing Material for Palatal Graft Donor Sites

Registry	NCT05814003, acronym RCT
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	30 (Estimated)
Sponsor	Assiut University (Other)
Conditions	Soft Tissue Infections, Gingival Recession
Interventions	hydroxylate flavones solid dispersion application, Placebo (Drug, other)
Dates	start 2023-04-20 (estimated), primary completion 2023-05-20 (estimated), completion 2023-05-20 (estimated), first posted 2023-04-14, last updated 2023-04-14
Locations	1 site in Egypt

-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 .

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
hydroxylate flavones	Experimental	Drug: hydroxylate flavones solid dispersion application; Other: Placebo	flavonoids mainly derived from citrus peel and have numerous strong biological activities, including anti-inflammatory , antioxidant , antimicrobial , and anticancer
alveogyl	Active comparator	Drug: hydroxylate flavones solid dispersion application; Other: 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	Placebo comparator	Drug: hydroxylate flavones solid dispersion application	acrylic resin material used to cover denuded soft tissues

hydroxylate flavones solid dispersion application (Drug), also known as Natural therapy without side effects: this drug has the antibacterial and anti inflammatory actions could help the palatal donor sites to promote the wound healing
Placebo (Other): Dough inert material without any therapeutic action

+Outcome measures

Primary outcomes

post operative pain (VAS scale) [first day postoperative to 30 days (days)]: VAS scale from 0 no pain to 10 excruciating pain (healing)

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Assiut University	Asyut	Egypt

+Publications

Paolantonio M, De Ninis P, Secondi L, Femminella B. The Full-Thickness Palatal Graft Technique: Description of an Original Surgical Technique and 15 Case Reports. Int J Periodontics Restorative Dent. 2019 Mar/Apr;39(2):267-277. doi: 10.11607/prd.3741. PMID 30794264
Zuhr O, Baumer D, Hurzeler M. The addition of soft tissue replacement grafts in plastic periodontal and implant surgery: critical elements in design and execution. J Clin Periodontol. 2014 Apr;41 Suppl 15:S123-42. doi: 10.1111/jcpe.12185. PMID 24640997
Wyrebek B, Gorski B, Gorska R. Patient morbidity at the palatal donor site depending on gingival graft dimension. Dent Med Probl. 2018 Apr-Jun;55(2):153-159. doi: 10.17219/dmp/91406. PMID 30152618
Tseng ES, Tavelli L, Wang HL. Palatal Pedicle Flaps for Soft Tissue Augmentation. Int J Periodontics Restorative Dent. 2020 Jul/Aug;40(4):581-588. doi: 10.11607/prd.4561. PMID 32559041

+Investigators

Ahmed Mortada, Professor, Principal investigator, Assiut University