Hydroxylated Polymethoxy Flavones Solid Dispersion in Treatment of Periodontitis

Study Overview
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Brief Summary
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Periodontitis is a serious gum infection that damages the soft tissue and, without treatment, can destroy the bone that supports your teeth. Hydroxylated poly methoxy flavones are a combination of naturally occurring flavonoids extracted from the orange peel and exert anti-inflammatory, antibacterial, and antifungal activity however, this extract is poorly soluble and poorly absorbable. In this work, this extract was formulated as a solid dispersion formulation to enhance its biological activity and then incorporated into a gel base and used in the treatment of periodontitis after clinical debridement.

Detailed Description
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In the study, there are 3 groups; the first one first one received plain sodium carboxymethylcellulose. Group II received chlorhexidine gel. GroupIII received Hydroxylated poly methoxy flavones solid dispersion incorporated into sodium carboxymethylcellulose gel. In all groups, there is clinical debridement before injection of gels.

Official Title
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The Effectiveness of Hydroxylated Polymethoxy Flavones Solid Dispersion Incorporated Sodium Carboxymethyl Cellulose Gel With Periodontal Debridement in the Treatment of Periodontitis. Clinical- Biochemical Study

Conditions
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Periodontal Diseases, Inflammatory Disease

Intervention / Treatment
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* Procedure: scaling and root planing
* Drug: hydroxylated poly methoxy flavones
* Drug: chlorhexidine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with periodontitis stage I-II free from any systemic disorders. no mobility - non-smokers - no parafunctional habits. Each patient with minimum three periodontitis sites ( split-mouth study) Exclusion Criteria: Smokers. patients with diabetes, and hypertension.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 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
Interventional Model Description: Three groups of patients with periodontitis, Group I received plain gel Group II received chlorhexidine gel Group III received hydroxylated polymethoxy flavones solid dispersion gel
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: hydroxylated polymethyl flavones group<br>SRP then hydroxylated polymethyl flavones addition | Procedure: scaling and root planing<br>* subgingival Depridement<br>Drug: hydroxylated poly methoxy flavones<br>* Received hydroxylated poly methoxy flavones extract solid dispersion incorporated into sodium carboxymethylcellulose gel<br>|
| Active Comparator: Chlorohexidine group<br>SRP then Chlorohexidine gel application | Procedure: scaling and root planing<br>* subgingival Depridement<br>Drug: chlorhexidine<br>* Received chlorhexidine gel<br>|
| Placebo Comparator: placebo group<br>SRP then placebo gel application | Procedure: scaling and root planing<br>* subgingival Depridement<br>Drug: placebo<br>* Received placebo gel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical attachment loss will be quantified in centimeters before and after treatment | Should be minimized in the group treated with Hydroxylated Polymethoxy Flavones gel than in other groups | One week | 
| Pocket Depth will be quantified in centimeters before and after treatment | Should be minimized in the group treated with Hydroxylated Polymethoxy Flavones gel | One week |