Hydroxylated Polymethoxy Flavones Solid Dispersion in Treatment of Periodontitis

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05546788
• Other study ID #: P.S.V.U 122/22
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: October 20, 2023
• Est. completion date: November 20, 2023

Study information

• Verified date: October 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 20, 2023
• Est. primary completion date: November 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammatory Disease
• Periodontal Diseases
• Periodontitis

Intervention

Procedure:
• scaling and root planing
subgingival Depridement

Drug:
• hydroxylated poly methoxy flavones
Received hydroxylated poly methoxy flavones extract solid dispersion incorporated into sodium carboxymethylcellulose gel
• chlorhexidine
Received chlorhexidine gel
• placebo
Received placebo gel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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