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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

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.

Condition or disease Intervention/treatment Phase
Generalized Aggressive Periodontitis Device: Ultrasonic Device: Hand Instruments Device: LED Source Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical And Microbiological Evaluations Of Adjunctive Photodynamic Therapy To Non-Surgical Periodontal Treatment In Patients With Generalized Aggressive Periodontitis
Actual Study Start Date : January 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : September 2012

Arm Intervention/treatment
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.
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

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.
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)




Primary Outcome Measures :
  1. Probing Depth [ Time Frame: 63 day ]
    defined as the distance from the free gingival margin to the bottom of the periodontal pocket



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03412331


Sponsors and Collaborators
Marmara University
Investigators
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Study Director: Leyla KURU, Prof. Dr. Marmara University, Faculty of Dentistry, Department of Periodontology

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Responsible Party: Marmara University
ClinicalTrials.gov Identifier: NCT03412331     History of Changes
Other Study ID Numbers: Borekci et al.
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Periodontitis
Aggressive Periodontitis
Aggression
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Behavioral Symptoms