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Curcumin-Simvastatin-EDTA in the Treatment of Periodontitis

Primary Purpose

Periodontitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
currettage
curcumin simvastatin paste
EDTA root conditioning
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring periodontitis, curcumin, simvastatin, EDTA

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patient suffering at least a single posterior 2-3 wall periodontal Pocket of depth ≥ 5 mm, attachment loss ≥3 mm, intrabony component ≥3 mm, plaque index ≤1 (Sillness and Loe, 1964) and sulcus bleeding index ≤1 (Mühlemann & Son, 1971). All these criteria were determined after phase I conventional periodontal therapy.
  • Systemically healthy as evidenced by burket's oral medicine health history question questionnaire (Glick et al., 2008).
  • Patients available during follow-up periods

Exclusion Criteria:

  • Smoking
  • Patient unwilling to comply with periodontal hygienic instructions
  • Patients under any long-term chronic medication
  • Vulnerable individuals

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Active Comparator

    Active Comparator

    Arm Label

    open flap debridement only

    curcumin and simvastatin

    EDTA, curcumin and simvastatin

    Arm Description

    surgical treatment of periodontal defects

    open flap debridement followed by application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).

    open flap debridement followed by 24% EDTA root surface etching and application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).

    Outcomes

    Primary Outcome Measures

    clinical score
    Probing depth (PD): evaluate the average reduction in probing depth measured in millimeters. Reduction in probing depth indicates that EDTA, simvastatin, and curcumin have positive effects in treatment.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 1, 2019
    Last Updated
    August 4, 2019
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04044417
    Brief Title
    Curcumin-Simvastatin-EDTA in the Treatment of Periodontitis
    Official Title
    Curcumin-Simvastatin Release Profile in the Gingival Crevicular Fluid Following EDTA Root Surface Etching in the Surgical Treatment of Intrabony Periodontal Defects - A Biochemical and Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    August 25, 2016 (Actual)
    Primary Completion Date
    May 5, 2018 (Actual)
    Study Completion Date
    October 3, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Among the root conditioning materials is the Ethylenediaminetetraacetic acid (EDTA). EDTA exposes the collagen fibers on dentin surfaces and also enhances early cell colonization. Statins have an anti-inflammatory effect, inhibit the bone resorption and stimulate the bone formation. Curcumin is effective in preventing periodontal disease destruction by targeting both bacteria and host inflammatory cells. Curcumin has anti- inflammatory, antioxidant, anticarcinogenic, antiviral, and antimicrobial functions. This study will be carried out to examine the effect of simvastatin-curcumin paste following EDTA root surface etching when used in conjunction with open flap debridement treating deep periodontal pockets (suggesting that it may have positive effect)
    Detailed Description
    The present study entailed thirty patients having stage II or stage III, Grade A periodontitis with 30 intrabony defects. Patients were divided into three groups; group I was subjected to open flap debridement only. Group II was subjected to open flap debridement followed by application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin). Group III was subjected to open flap debridement followed by 24% EDTA root surface etching and application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).Clinical parameters including plaque index, sulcus bleeding index, probing depth and clinical attachment level were recorded pre-surgical. Moreover, radiographic examination was performed by cone beam computed tomography (CBCT) just before the surgery . Vertical bone defects were exposed by full thickness mucoperiosteal flap following intrasulcular incision and thorough debridement was performed. Group II received local application of curcumin-simvastatin paste .Group III received curcumin-simvastatin paste after debridement and 24 % EDTA. The same initial clinical parameters were recorded three and six months postoperatively. Radiographic measurements were recorded six months post surgically.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis
    Keywords
    periodontitis, curcumin, simvastatin, EDTA

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    open flap debridement only
    Arm Type
    Placebo Comparator
    Arm Description
    surgical treatment of periodontal defects
    Arm Title
    curcumin and simvastatin
    Arm Type
    Active Comparator
    Arm Description
    open flap debridement followed by application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).
    Arm Title
    EDTA, curcumin and simvastatin
    Arm Type
    Active Comparator
    Arm Description
    open flap debridement followed by 24% EDTA root surface etching and application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).
    Intervention Type
    Procedure
    Intervention Name(s)
    currettage
    Other Intervention Name(s)
    surgical treatment of periodontal defects
    Intervention Description
    open flap debridement
    Intervention Type
    Drug
    Intervention Name(s)
    curcumin simvastatin paste
    Other Intervention Name(s)
    open flap debridement followed by application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).
    Intervention Description
    Curcumin is the primary active constituent of turmeric. Simvastatin is chemical modification of lovastatin.
    Intervention Type
    Drug
    Intervention Name(s)
    EDTA root conditioning
    Other Intervention Name(s)
    open flap debridement followed by 24% EDTA root surface etching and application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).
    Intervention Description
    EDTA is an aminopolycarboxylic acid and a colourless, water-soluble solid
    Primary Outcome Measure Information:
    Title
    clinical score
    Description
    Probing depth (PD): evaluate the average reduction in probing depth measured in millimeters. Reduction in probing depth indicates that EDTA, simvastatin, and curcumin have positive effects in treatment.
    Time Frame
    change from base line to 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patient suffering at least a single posterior 2-3 wall periodontal Pocket of depth ≥ 5 mm, attachment loss ≥3 mm, intrabony component ≥3 mm, plaque index ≤1 (Sillness and Loe, 1964) and sulcus bleeding index ≤1 (Mühlemann & Son, 1971). All these criteria were determined after phase I conventional periodontal therapy. Systemically healthy as evidenced by burket's oral medicine health history question questionnaire (Glick et al., 2008). Patients available during follow-up periods Exclusion Criteria: Smoking Patient unwilling to comply with periodontal hygienic instructions Patients under any long-term chronic medication Vulnerable individuals
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ahmed Y Gamal, Professor
    Organizational Affiliation
    Faculty of dentistry- Ain shams university
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Curcumin-Simvastatin-EDTA in the Treatment of Periodontitis

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