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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Disease

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts 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.

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

    First Posted
    September 4, 2022
    Last Updated
    October 7, 2023
    Sponsor
    Assiut University
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    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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