Hydroxylated Polymethoxy Flavones Solid Dispersion in Treatment of Periodontitis

NCT ID: NCT05546788

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-20
• Study Completion Date: 2023-11-20

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.

Conditions

Inflammatory Disease; Periodontal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

hydroxylated polymethyl flavones group

SRP then hydroxylated polymethyl flavones addition

Group Type: ACTIVE_COMPARATOR

scaling and root planing

Intervention Type: PROCEDURE

subgingival Depridement

hydroxylated poly methoxy flavones

Intervention Type: DRUG

Received hydroxylated poly methoxy flavones extract solid dispersion incorporated into sodium carboxymethylcellulose gel

Chlorohexidine group

SRP then Chlorohexidine gel application

Group Type: ACTIVE_COMPARATOR

scaling and root planing

Intervention Type: PROCEDURE

subgingival Depridement

chlorhexidine

Intervention Type: DRUG

Received chlorhexidine gel

placebo group

SRP then placebo gel application

Group Type: PLACEBO_COMPARATOR

scaling and root planing

Intervention Type: PROCEDURE

subgingival Depridement

placebo

Intervention Type: DRUG

Received placebo gel

Interventions

scaling and root planing

subgingival Depridement

Intervention Type: PROCEDURE

hydroxylated poly methoxy flavones

Received hydroxylated poly methoxy flavones extract solid dispersion incorporated into sodium carboxymethylcellulose gel

Intervention Type: DRUG

chlorhexidine

Received chlorhexidine gel

Intervention Type: DRUG

placebo

Received placebo gel

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mortada

Head of Department of Oral Medicine, Periodontology and Diagnosis

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

P.S.V.U 122/22

Identifier Type: -

Identifier Source: org_study_id