Inflammatory Disease, Periodontal Diseases
Conditions
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.
Interventions
PROCEDUREscaling and root planing
subgingival Depridement
DRUGhydroxylated poly methoxy flavones
Received hydroxylated poly methoxy flavones extract solid dispersion incorporated into sodium carboxymethylcellulose gel
DRUGchlorhexidine
Received chlorhexidine gel
DRUGplacebo
Received placebo gel
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical attachment loss will be quantified in centimeters before and after treatment | One week | Should be minimized in the group treated with Hydroxylated Polymethoxy Flavones gel than in other groups |
| Pocket Depth will be quantified in centimeters before and after treatment | One week | Should be minimized in the group treated with Hydroxylated Polymethoxy Flavones gel |
Outcome results
None listed