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Curcumin Paste as an Adjunctive Therapy in Periodontitis

Primary Purpose

Periodontitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
curcumin paste
curettage
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 curcumin, CBCT, HPLC, periodontitis

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Male or female with age range 25-45 years.
  2. At least a single posterior 2-3 wall periodontal defect of pocket depth ≥ 5mm; clinical attachment level ≥ 3 mm, Intrabony component ≥ 3 mm and with plaque index ≤1 (Löe 1967) and bleeding index ≤1 (Mühlemann & Son 1971). All the previous criteria were determined 2 weeks after phase I conventional periodontal therapy.
  3. Systemically Healthy as evidenced by Burket's oral medicine health history questionnaire (Glick et al., 2008).

Exclusion Criteria:

  • 1- Smokers. 2- Pregnant. 3- Patient unwilling to comply to periodontaloral hygienic instructions. 4- Vulnerable groups. (e.g: Decisionally impaired individual)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    curcumin paste in conjunction with open flap debridement surge

    open flap debridement surgery only

    Arm Description

    curcumin paste (2% circumin) in conjunction with open flap debridement surgery

    surgical treatment for periodontal pocket

    Outcomes

    Primary Outcome Measures

    clinical score
    Evaluate the influence of curcumin paste on the clinical outcomes of the surgical treatment.to see if curcumin has a positive effect in reduction oh deep periodontal pockets and leads to greater bone gain

    Secondary Outcome Measures

    Full Information

    First Posted
    July 19, 2019
    Last Updated
    July 23, 2019
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04032132
    Brief Title
    Curcumin Paste as an Adjunctive Therapy in Periodontitis
    Official Title
    The Local Application of Curcumin in Conjunction With the Surgical Treatment of Intrabony Periodontal Defects "Controlled Clinical Study With Evaluation of Curcumin Release Profile"
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    August 20, 2016 (Actual)
    Primary Completion Date
    May 6, 2018 (Actual)
    Study Completion Date
    November 5, 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
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The turmeric (Curcuma longa) plant, a herb belonging to the ginger family. The most active component of turmeric is curcumin, which makes up 2 to 5% of the spice. Curcumin showed has antibacterial effect against periodontal pathogen and positive result regarding conventional treatment of periodontal disease due to its anti-inflammatory, anti-oxidant and wound healing properties. This study will be carried out to examine the effect of curcumin 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 twenty four patients having stage II or stage III, Grade A periodontitis with 24 intrabony defects. Patients were divided into two groups; group I was subjected to open flap debridement only. Group II was subjected to curcumin paste (2%curcumin)in conjunction with open flap debridement 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 paste.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
    curcumin, CBCT, HPLC, periodontitis

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    curcumin paste in conjunction with open flap debridement surge
    Arm Type
    Experimental
    Arm Description
    curcumin paste (2% circumin) in conjunction with open flap debridement surgery
    Arm Title
    open flap debridement surgery only
    Arm Type
    Placebo Comparator
    Arm Description
    surgical treatment for periodontal pocket
    Intervention Type
    Drug
    Intervention Name(s)
    curcumin paste
    Intervention Description
    curcumin is a herb used for medical purpose
    Intervention Type
    Procedure
    Intervention Name(s)
    curettage
    Intervention Description
    open flab debridement surgery
    Primary Outcome Measure Information:
    Title
    clinical score
    Description
    Evaluate the influence of curcumin paste on the clinical outcomes of the surgical treatment.to see if curcumin has a positive effect in reduction oh deep periodontal pockets and leads to greater bone gain
    Time Frame
    change from base line at 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Male or female with age range 25-45 years. At least a single posterior 2-3 wall periodontal defect of pocket depth ≥ 5mm; clinical attachment level ≥ 3 mm, Intrabony component ≥ 3 mm and with plaque index ≤1 (Löe 1967) and bleeding index ≤1 (Mühlemann & Son 1971). All the previous criteria were determined 2 weeks after phase I conventional periodontal therapy. Systemically Healthy as evidenced by Burket's oral medicine health history questionnaire (Glick et al., 2008). Exclusion Criteria: 1- Smokers. 2- Pregnant. 3- Patient unwilling to comply to periodontaloral hygienic instructions. 4- Vulnerable groups. (e.g: Decisionally impaired individual)
    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

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    Curcumin Paste as an Adjunctive Therapy in Periodontitis

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