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

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

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 .

Study Overview

• Status: Not yet recruiting
• Conditions: Gingival Recession; Soft Tissue Infections
• Intervention / Treatment: Drug: hydroxylate flavones solid dispersion application; Other: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Mortada, professor; Phone Number: 20 0100 543 2223; Email: mortadafikry@hotmail.com

Study Locations

• Egypt
  • Assiut, Egypt
    • Assiut University
    • Contact: ahmed fikry; Phone Number: 002 01005432223; Email: mortadafikry@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hydroxylate flavones; flavonoids mainly derived from citrus peel and have numerous strong biological activities, including anti-inflammatory , antioxidant , antimicrobial , and anticancer	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 Names: Natural therapy without side effects; Other: Placebo; Dough inert material without any therapeutic action
Active Comparator: alveogyl; 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.	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 Names: Natural therapy without side effects; Other: Placebo; Dough inert material without any therapeutic action
Placebo Comparator: stent; acrylic resin material used to cover denuded soft tissues	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 Names: Natural therapy without side effects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post operative pain (VAS scale)	VAS scale from 0 no pain to 10 excruciating pain (healing)	first day postoperative to 30 days (days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Ahmed Mortada, Professor, Assiut University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 20, 2023
• Primary Completion (Anticipated): May 20, 2023
• Study Completion (Anticipated): May 20, 2023

Study Registration Dates

• First Submitted: October 10, 2022
• First Submitted That Met QC Criteria: April 13, 2023
• First Posted (Actual): April 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession; Soft Tissue Infections
• Other Study ID Numbers: HW37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No