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

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ClinicalTrials.gov Identifier: NCT03412331
Recruitment Status : Completed
First Posted : January 26, 2018
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Marmara University

Tracking Information
First Submitted Date  ICMJE January 21, 2018
First Posted Date  ICMJE January 26, 2018
Last Update Posted Date January 26, 2018
Actual Study Start Date  ICMJE January 2008
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2018)
Probing Depth [ Time Frame: 63 day ]
defined as the distance from the free gingival margin to the bottom of the periodontal pocket
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects Of Adjunctive Photodynamic Therapy To Non-Surgical Periodontal Treatment In Patients With Generalized Aggressive Periodontitis
Official Title  ICMJE Clinical And Microbiological Evaluations Of Adjunctive Photodynamic Therapy To Non-Surgical Periodontal Treatment In Patients With Generalized Aggressive Periodontitis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Generalized Aggressive Periodontitis
Intervention  ICMJE
  • Device: Ultrasonic
    Cavitron® BOBCAT® Pro, Dentsply International, USA
  • Device: Hand Instruments
    Gracey, SG 5/6, 7/8, 11/12, 13/14, Hu-Friedy Ins. Co., USA
  • Device: LED Source
    LED source (625-635 nm wavelength) (FotoSan®, CMS Dental, Denmark)
Study Arms  ICMJE
  • Active Comparator: Control Group
    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.
    Interventions:
    • Device: Ultrasonic
    • Device: Hand Instruments
  • Experimental: Test Group
    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.
    Interventions:
    • Device: Ultrasonic
    • Device: Hand Instruments
    • Device: LED Source
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 25, 2018)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03412331
Other Study ID Numbers  ICMJE Borekci et al.
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Marmara University
Study Sponsor  ICMJE Marmara University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Leyla KURU, Prof. Dr. Marmara University, Faculty of Dentistry, Department of Periodontology
PRS Account Marmara University
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP