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

Primary Purpose

Soft Tissue Infections, Gingival Recession

Status

Not yet recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

hydroxylate flavones solid dispersion application

Placebo

About this trial

This is an interventional treatment trial for Soft Tissue Infections

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Assiut University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

hydroxylate flavones

alveogyl

stent

Arm Description

flavonoids mainly derived from citrus peel and have numerous strong biological activities, including anti-inflammatory , antioxidant , antimicrobial , and anticancer

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.

acrylic resin material used to cover denuded soft tissues

Outcomes

Primary Outcome Measures

post operative pain (VAS scale)

VAS scale from 0 no pain to 10 excruciating pain (healing)

Secondary Outcome Measures

Number of analgesic and anti inflammatory pills consumed

Minimizing the pain and inflammation during healing process post operative swelling

Full Information

NCT ID

NCT05814003

First Posted

October 10, 2022

Last Updated

April 13, 2023

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT05814003

Brief Title

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

Acronym

RCT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

April 20, 2023 (Anticipated)

Primary Completion Date

May 20, 2023 (Anticipated)

Study Completion Date

May 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Soft Tissue Infections, Gingival Recession

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

hydroxylate flavones

Arm Type

Experimental

Arm Description

flavonoids mainly derived from citrus peel and have numerous strong biological activities, including anti-inflammatory , antioxidant , antimicrobial , and anticancer

Arm Title

alveogyl

Arm Type

Active Comparator

Arm Description

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.

Arm Title

stent

Arm Type

Placebo Comparator

Arm Description

acrylic resin material used to cover denuded soft tissues

Intervention Type

Drug

Intervention Name(s)

hydroxylate flavones solid dispersion application

Other Intervention Name(s)

Natural therapy without side effects

Intervention Description

this drug has the antibacterial and anti inflammatory actions could help the palatal donor sites to promote the wound healing

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Dough inert material without any therapeutic action

Primary Outcome Measure Information:

Title

post operative pain (VAS scale)

Description

VAS scale from 0 no pain to 10 excruciating pain (healing)

Time Frame

first day postoperative to 30 days (days)

Secondary Outcome Measure Information:

Title

Number of analgesic and anti inflammatory pills consumed

Description

Minimizing the pain and inflammation during healing process post operative swelling

Time Frame

first day postoperative to 30 days (days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ahmed Mortada, professor

Phone

20 0100 543 2223

mortadafikry@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed Mortada, Professor

Organizational Affiliation

Assiut University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Assiut University

City

Assiut

Country

Egypt

Facility Contact:

First Name & Middle Initial & Last Name & Degree

ahmed fikry

Phone

01005432223

Ext

002

mortadafikry@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30794264

Citation

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.

Results Reference

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PubMed Identifier

24640997

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.

Results Reference

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PubMed Identifier

30152618

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.

Results Reference

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PubMed Identifier

32559041

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.

Results Reference

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

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