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Effects Of Adjunctive Photodynamic Therapy To Non-Surgical Periodontal Treatment In Patients With Generalized Aggressive Periodontitis

Primary Purpose

Generalized Aggressive Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasonic
Hand Instruments
LED Source
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Aggressive Periodontitis

Eligibility Criteria

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

Inclusion Criteria:

  • systemically healthy,
  • non-smoker
  • not received any periodontal treatment within the last 6 months
  • no antibiotics, anti-inflammatory drugs or any other medication taken within the last 6 months
  • consent to participate in the study

Exclusion Criteria:

  • any systemic disease (i.e. diabetes mellitus, HIV infection) that might influence the prognosis of periodontal disease and outcome of the treatment
  • any medical condition that required antibiotic prophylaxis before the treatment
  • smoking
  • pregnancy and lactation
  • ingestion of antibiotics, anti-inflammatory drugs or any other medication during study period
  • any physical limitations or restrictions that might preclude normal oral hygiene procedures

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Control Group

    Test Group

    Arm Description

    NPT including scaling and root planing was applied to 12 subjects with ultrasonic and hand instruments until the operator feels that root surface is clean, hard and smooth.

    Following NPT, toluidine blue O mediated PDT was performed with a LED source (625-635 nm wavelength) (FotoSan®, CMS Dental, Denmark) to 12 subjects. The dye (0.1 mg/ml) was applied with a canula into the periodontal pockets. After 3 minutes, the subjects rinsed their mouths with sterile saline solution for removal of excessive dye. Then, the applicator of photosensitizer was inserted until the bottom of the periodontal pocket and photoinactivation was performed in 6 sites per tooth for 10 seconds of each sites with a total of 60 seconds per tooth.

    Outcomes

    Primary Outcome Measures

    Probing Depth
    defined as the distance from the free gingival margin to the bottom of the periodontal pocket

    Secondary Outcome Measures

    Full Information

    First Posted
    January 21, 2018
    Last Updated
    January 25, 2018
    Sponsor
    Marmara University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03412331
    Brief Title
    Effects Of Adjunctive Photodynamic Therapy To Non-Surgical Periodontal Treatment In Patients With Generalized Aggressive Periodontitis
    Official Title
    Clinical And Microbiological Evaluations Of Adjunctive Photodynamic Therapy To Non-Surgical Periodontal Treatment In Patients With Generalized Aggressive Periodontitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2008 (Actual)
    Primary Completion Date
    January 2011 (Actual)
    Study Completion Date
    September 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Marmara University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No

    5. Study Description

    Brief Summary
    Generalized aggressive periodontitis (GAgP) is a distinct type of periodontal disease characterized by rapid loss of attachment and alveolar bone occuring in young individuals. Photodynamic therapy (PDT) was introduced in periodontology as an adjunctive approach to non-surgical periodontal treatment (NPT) in periodontitis patients. In this trial, it was aimed that to evaluate the clinical and microbiological effects of adjunctive PDT to NPT in patients with GAgP. In this prospective controlled clinical study, 24 systemically healthy, non-smoking subjects with GAgP were enrolled. Subjects were randomly assigned to a control group (n=12) treated with NPT only or to a test group (n=12) treated with NPT and PDT. Plaque index, sulcus bleeding index (SBI), pocket depth (PD), relative attachment level, gingival recession, mobility were recorded at baseline and on day 63. Microbiological samples were obtained fom the sites with PD ≥5 mm at the same time points and evaluated for Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia and Treponema denticola using micro-IDent test.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    NPT including scaling and root planing was applied to 12 subjects with ultrasonic and hand instruments until the operator feels that root surface is clean, hard and smooth.
    Arm Title
    Test Group
    Arm Type
    Experimental
    Arm Description
    Following NPT, toluidine blue O mediated PDT was performed with a LED source (625-635 nm wavelength) (FotoSan®, CMS Dental, Denmark) to 12 subjects. The dye (0.1 mg/ml) was applied with a canula into the periodontal pockets. After 3 minutes, the subjects rinsed their mouths with sterile saline solution for removal of excessive dye. Then, the applicator of photosensitizer was inserted until the bottom of the periodontal pocket and photoinactivation was performed in 6 sites per tooth for 10 seconds of each sites with a total of 60 seconds per tooth.
    Intervention Type
    Device
    Intervention Name(s)
    Ultrasonic
    Intervention Description
    Cavitron® BOBCAT® Pro, Dentsply International, USA
    Intervention Type
    Device
    Intervention Name(s)
    Hand Instruments
    Intervention Description
    Gracey, SG 5/6, 7/8, 11/12, 13/14, Hu-Friedy Ins. Co., USA
    Intervention Type
    Device
    Intervention Name(s)
    LED Source
    Intervention Description
    LED source (625-635 nm wavelength) (FotoSan®, CMS Dental, Denmark)
    Primary Outcome Measure Information:
    Title
    Probing Depth
    Description
    defined as the distance from the free gingival margin to the bottom of the periodontal pocket
    Time Frame
    63 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: systemically healthy, non-smoker not received any periodontal treatment within the last 6 months no antibiotics, anti-inflammatory drugs or any other medication taken within the last 6 months consent to participate in the study Exclusion Criteria: any systemic disease (i.e. diabetes mellitus, HIV infection) that might influence the prognosis of periodontal disease and outcome of the treatment any medical condition that required antibiotic prophylaxis before the treatment smoking pregnancy and lactation ingestion of antibiotics, anti-inflammatory drugs or any other medication during study period any physical limitations or restrictions that might preclude normal oral hygiene procedures
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Leyla KURU, Prof. Dr.
    Organizational Affiliation
    Marmara University, Faculty of Dentistry, Department of Periodontology
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effects Of Adjunctive Photodynamic Therapy To Non-Surgical Periodontal Treatment In Patients With Generalized Aggressive Periodontitis

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