Hydroxylated Polymethoxy Flavones Solid Dispersion in Treatment of Periodontitis

NCT05546788 | Unknown Phase 1

• 1 other identifier: P.S.V.U 122/22
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Inflammatory Disease; Periodontal Diseases

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

hydroxylated polymethyl flavones group

ACTIVE COMPARATOR

SRP then hydroxylated polymethyl flavones addition

Procedure: scaling and root planing; Drug: hydroxylated poly methoxy flavones

Chlorohexidine group

ACTIVE COMPARATOR

SRP then Chlorohexidine gel application

Procedure: scaling and root planing; Drug: chlorhexidine

placebo group

PLACEBO COMPARATOR

SRP then placebo gel application

Procedure: scaling and root planing; Drug: placebo

Interventions

scaling and root planing PROCEDURE

subgingival Depridement

Chlorohexidine group; hydroxylated polymethyl flavones group; placebo group

hydroxylated poly methoxy flavones DRUG

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

hydroxylated polymethyl flavones group

chlorhexidine DRUG

Received chlorhexidine gel

Chlorohexidine group

placebo DRUG

Received placebo gel

placebo group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Smokers.
• patients with diabetes, and hypertension.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Tooth Exfoliation; Root Planing; Chlorhexidine

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Oral Medicine, Periodontology and Diagnosis

Model Details: 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

Study Record Dates

• First Submitted: September 4, 2022
• First Posted: September 21, 2022
• Study Start: October 20, 2023
• Primary Completion: November 20, 2023
• Study Completion: November 20, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share