Hydroxylated Polymethoxy Flavones Solid Dispersion in Treatment of Periodontitis
Primary Purpose
Inflammatory Disease, Periodontal Diseases
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
scaling and root planing
hydroxylated poly methoxy flavones
chlorhexidine
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Disease
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
hydroxylated polymethyl flavones group
Chlorohexidine group
placebo group
Arm Description
SRP then hydroxylated polymethyl flavones addition
SRP then Chlorohexidine gel application
SRP then placebo gel application
Outcomes
Primary Outcome Measures
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
Pocket Depth will be quantified in centimeters before and after treatment
Should be minimized in the group treated with Hydroxylated Polymethoxy Flavones gel
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05546788
Brief Title
Hydroxylated Polymethoxy Flavones Solid Dispersion in Treatment of Periodontitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 20, 2023 (Anticipated)
Primary Completion Date
November 20, 2023 (Anticipated)
Study Completion Date
November 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Disease, Periodontal Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
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
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hydroxylated polymethyl flavones group
Arm Type
Active Comparator
Arm Description
SRP then hydroxylated polymethyl flavones addition
Arm Title
Chlorohexidine group
Arm Type
Active Comparator
Arm Description
SRP then Chlorohexidine gel application
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
SRP then placebo gel application
Intervention Type
Procedure
Intervention Name(s)
scaling and root planing
Intervention Description
subgingival Depridement
Intervention Type
Drug
Intervention Name(s)
hydroxylated poly methoxy flavones
Intervention Description
Received hydroxylated poly methoxy flavones extract solid dispersion incorporated into sodium carboxymethylcellulose gel
Intervention Type
Drug
Intervention Name(s)
chlorhexidine
Intervention Description
Received chlorhexidine gel
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Received placebo gel
Primary Outcome Measure Information:
Title
Clinical attachment loss will be quantified in centimeters before and after treatment
Description
Should be minimized in the group treated with Hydroxylated Polymethoxy Flavones gel than in other groups
Time Frame
One week
Title
Pocket Depth will be quantified in centimeters before and after treatment
Description
Should be minimized in the group treated with Hydroxylated Polymethoxy Flavones gel
Time Frame
One week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hydroxylated Polymethoxy Flavones Solid Dispersion in Treatment of Periodontitis
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