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

Gingival Recession Clinical Trial

— RCT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05814003
• Other study ID #: HW37
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 20, 2023
• Est. completion date: May 20, 2023

Study information

• Verified date: April 2023
• Source: Assiut University
• Contact: Ahmed Mortada, professor
• Phone: 20 0100 543 2223
• Email: mortadafikry[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 20, 2023
• Est. primary completion date: May 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession
• Soft Tissue Infections

Intervention

Drug:
• hydroxylate flavones solid dispersion application
this drug has the antibacterial and anti inflammatory actions could help the palatal donor sites to promote the wound healing

Other:
• Placebo
Dough inert material without any therapeutic action

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post operative pain (VAS scale)	VAS scale from 0 no pain to 10 excruciating pain (healing)	first day postoperative to 30 days (days)
Secondary	Number of analgesic and anti inflammatory pills consumed	Minimizing the pain and inflammation during healing process post operative swelling	first day postoperative to 30 days (days)