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PDT As An Adjunct To SRP In The Management of Chronic Periodontitis

Primary Purpose

Chronic Periodontitis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Photodynamic therapy
Sponsored by
KLE Society's Institute of Dental Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis

Eligibility Criteria

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

Inclusion Criteria:

  • Patients of both genders diagnosed with chronic periodontitis in the age group of 30 to 50 years with good systemic health.
  • Presence of a minimum of 20 teeth and at least one site with probing pocket depth (PPD) of 4-7 mm and clinical attachment level (CAL) of 2 mm or greater, in each of the four quadrants.

Exclusion Criteria:

  • Patients who have undergone periodontal therapy during the previous 6 months of commencement of the study.
  • Subjects on antibiotics or immunosuppressant medication 6 months prior to the study.
  • Chronic Smokers, Alcoholics, Smokeless tobacco users.
  • Subjects with acute illnesses/acute intraoral lesions.
  • Pregnant women and lactating mothers.
  • Medically compromised subjects.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Placebo Comparator

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Placebo group

    Zinc oxide gel group

    PDT group

    Zinc oxide and PDT group

    Arm Description

    Application of placebo gel followed by sham Photodynamic therapy

    Application of Zinc oxide gel followed by sham Photodynamic therapy.

    Application of placebo gel followed by Photodynamic therapy.

    Application of Zinc oxide gel followed by Photodynamic therapy.

    Outcomes

    Primary Outcome Measures

    Change in Microbial profile
    Change in levels of P.gingivalis following PDT

    Secondary Outcome Measures

    Change in Plaque index score
    Change in plaque index score from Range: 2-3 to Range: 0 to1.9 following PDT
    Change in Gingival index score
    Change in Gingival index score from Range: 2-3 to Range: 0 to1.9 following PDT
    Probing pocket depth
    Change in probing pocket depth from 5-7 mm to 2.9- 4.2 mm following PDT
    Clinical attachment level
    Gain in clinical attachment level following PDT

    Full Information

    First Posted
    December 6, 2018
    Last Updated
    February 25, 2019
    Sponsor
    KLE Society's Institute of Dental Sciences
    Collaborators
    University of Mysore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03770819
    Brief Title
    PDT As An Adjunct To SRP In The Management of Chronic Periodontitis
    Official Title
    Photodynamic Therapy Using Zinc Oxide Photosensitizer As An Adjunct To Scaling And Root Planing In The Management Of Chronic Periodontitis - A Split Mouth Double Blind Randomized Controlled Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2019 (Anticipated)
    Primary Completion Date
    May 2019 (Anticipated)
    Study Completion Date
    June 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    KLE Society's Institute of Dental Sciences
    Collaborators
    University of Mysore

    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
    The present study aims to evaluate photodynamic therapy (PDT) using Zinc oxide as a photosensitizer as an adjunct to scaling and root planing (SRP) in the management of chronic periodontitis.
    Detailed Description
    Following full mouth SRP, each quadrant will be randomly assigned by simple randomization using a computer generated randomization technique into one of the following four treatment modalities. Group 1 (control) - Application of placebo gel followed by sham PDT (Directing the Light cure device without turning on the light beam). Group 2 -Application of Zinc oxide gel followed by sham PDT. Group 3 - Application of placebo gel followed by PDT. Group 4 - Application of Zinc oxide gel followed by PDT. The procedure mentioned for each group will be performed on all periodontal pockets in the assigned quadrant at baseline, end of 1 week and 1 month from the first session. Clinical parameters and microbial profile will be recorded at baseline (before commencement of Periodontal treatment), end of 1 month and end of 3 months following periodontal treatment. Zinc oxide gel/placebo gel will be placed into the periodontal pockets using a blunt cannula ensuring that starting from the bottom, it completely fills the periodontal pockets. The gel will be retained in the pocket for 5 minutes. The perio tip will be attached to the hand piece of the light cure unit (Wavelength: 420-480nm. Light power: 1200mw/cm2 in continuous mode) and light will be activated for 60 seconds. Following this, the pockets will be irrigated with normal saline solution (0.9%Sodium chloride).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Periodontitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    16 patients contributing a total of 64 sites will be selected. Recording of clinical and microbiological parameters will be done at baseline, end of 1 month, and 3 months. Oral hygiene instructions will be given. Following full mouth SRP, each quadrant will be randomly assigned by simple randomization using a computer generated randomization technique into one of the following four treatment modalities. Group 1 (control) - Application of placebo gel followed by sham PDT (Directing the Light cure device without turning on the light beam). Group 2 -Application of Zinc oxide gel followed by sham PDT. Group 3 - Application of placebo gel followed by PDT. Group 4 - Application of Zinc oxide gel followed by PDT. The procedure mentioned for each group will be performed on all periodontal pockets in the assigned quadrant at baseline, end of 1 week and 1 month from the first session. Study period - 3 months
    Masking
    ParticipantCare Provider
    Masking Description
    This is a Split Mouth Double Blind Randomized Controlled Clinical Trial in which both participants and care provider are blinded.
    Allocation
    Randomized
    Enrollment
    16 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    Application of placebo gel followed by sham Photodynamic therapy
    Arm Title
    Zinc oxide gel group
    Arm Type
    Active Comparator
    Arm Description
    Application of Zinc oxide gel followed by sham Photodynamic therapy.
    Arm Title
    PDT group
    Arm Type
    Experimental
    Arm Description
    Application of placebo gel followed by Photodynamic therapy.
    Arm Title
    Zinc oxide and PDT group
    Arm Type
    Experimental
    Arm Description
    Application of Zinc oxide gel followed by Photodynamic therapy.
    Intervention Type
    Procedure
    Intervention Name(s)
    Photodynamic therapy
    Intervention Description
    Zinc oxide gel/placebo gel will be placed into the periodontal pockets using a blunt cannula ensuring that starting from the bottom, it completely fills the periodontal pockets. The gel will be retained in the pocket for 5 minutes. The perio tip will be attached to the hand piece of the light cure unit (Wavelength: 420-480nm. Light power: 1200mw/cm2 in continuous mode) and light will be activated for 60 seconds. Following this, the pockets will be irrigated with normal saline solution (0.9%Sodium chloride). For groups 1 and 2, sham PDT will be performed by directing the Light cure device without turning on the light beam.
    Primary Outcome Measure Information:
    Title
    Change in Microbial profile
    Description
    Change in levels of P.gingivalis following PDT
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Change in Plaque index score
    Description
    Change in plaque index score from Range: 2-3 to Range: 0 to1.9 following PDT
    Time Frame
    3 months
    Title
    Change in Gingival index score
    Description
    Change in Gingival index score from Range: 2-3 to Range: 0 to1.9 following PDT
    Time Frame
    3 months
    Title
    Probing pocket depth
    Description
    Change in probing pocket depth from 5-7 mm to 2.9- 4.2 mm following PDT
    Time Frame
    3 months
    Title
    Clinical attachment level
    Description
    Gain in clinical attachment level following PDT
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients of both genders diagnosed with chronic periodontitis in the age group of 30 to 50 years with good systemic health. Presence of a minimum of 20 teeth and at least one site with probing pocket depth (PPD) of 4-7 mm and clinical attachment level (CAL) of 2 mm or greater, in each of the four quadrants. Exclusion Criteria: Patients who have undergone periodontal therapy during the previous 6 months of commencement of the study. Subjects on antibiotics or immunosuppressant medication 6 months prior to the study. Chronic Smokers, Alcoholics, Smokeless tobacco users. Subjects with acute illnesses/acute intraoral lesions. Pregnant women and lactating mothers. Medically compromised subjects.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    PDT As An Adjunct To SRP In The Management of Chronic Periodontitis

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