Hydroxylated Polymethoxy Flavones Solid Dispersion in Treatment of Periodontitis

Assiut University

Status and phase: Not yet enrolling; Phase 1

Conditions: Periodontal Diseases; Inflammatory Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05546788

P.S.V.U 122/22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 3 patient groups, including a placebo group

hydroxylated polymethyl flavones group

Active Comparator group

Description:

SRP then hydroxylated polymethyl flavones addition

Treatment:

Drug: hydroxylated poly methoxy flavones

Procedure: scaling and root planing

Chlorohexidine group

Active Comparator group

Description:

SRP then Chlorohexidine gel application

Treatment:

Drug: chlorhexidine

Procedure: scaling and root planing

placebo group

Placebo Comparator group

Description:

SRP then placebo gel application

Treatment:

Drug: placebo

Procedure: scaling and root planing