Hydroxylated Polymethoxy Flavones Solid Dispersion in Treatment of Periodontitis

Phase 1

Not yet recruiting

• Conditions: Inflammatory Disease; Periodontal Diseases
• Interventions: Procedure: scaling and root planing; Drug: placebo; Drug: hydroxylated poly methoxy flavones; Drug: chlorhexidine

• Registration Number: NCT05546788
• Lead Sponsor: Assiut University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-09-04
• Study First Submitted QC: 2022-09-15
• Study First Posted: 2022-09-21
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-07
• Last Update Posted: 2023-10-10
• Study Start: 2023-10-20
• Primary Completion: 2023-11-20
• Study Completion: 2023-11-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chlorohexidine group	scaling and root planing	SRP then Chlorohexidine gel application
placebo group	placebo	SRP then placebo gel application
hydroxylated polymethyl flavones group	scaling and root planing	SRP then hydroxylated polymethyl flavones addition
hydroxylated polymethyl flavones group	hydroxylated poly methoxy flavones	SRP then hydroxylated polymethyl flavones addition
placebo group	scaling and root planing	SRP then placebo gel application
Chlorohexidine group	chlorhexidine	SRP then Chlorohexidine gel application

Primary Outcome Measures

Name	Time	Method
Clinical attachment loss will be quantified in centimeters before and after treatment	One week	Should be minimized in the group treated with Hydroxylated Polymethoxy Flavones gel than in other groups
Pocket Depth will be quantified in centimeters before and after treatment	One week	Should be minimized in the group treated with Hydroxylated Polymethoxy Flavones gel