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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05546788
Other study ID # P.S.V.U 122/22
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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