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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Soft Tissue Infections, Gingival Recession

Intervention / Treatment
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* Drug: hydroxylate flavones solid dispersion application
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hydroxylate flavones<br>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<br>* this drug has the antibacterial and anti inflammatory actions could help the palatal donor sites to promote the wound healing<br>* Other names: Natural therapy without side effects;Other: Placebo<br>* Dough inert material without any therapeutic action<br>|
| Active Comparator: alveogyl<br>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<br>* this drug has the antibacterial and anti inflammatory actions could help the palatal donor sites to promote the wound healing<br>* Other names: Natural therapy without side effects;Other: Placebo<br>* Dough inert material without any therapeutic action<br>|
| Placebo Comparator: stent<br>acrylic resin material used to cover denuded soft tissues | Drug: hydroxylate flavones solid dispersion application<br>* this drug has the antibacterial and anti inflammatory actions could help the palatal donor sites to promote the wound healing<br>* Other names: Natural therapy without side effects;|

What is the study measuring?
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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) |