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CompletedNCT03412331Updated Jan 26, 2018

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

An interventional study of Ultrasonic and Hand Instruments in Generalized Aggressive Periodontitis, sponsored by Marmara University. Completed. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-26.

Sponsored by Marmara University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Generalized Aggressive Periodontitis
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • 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 · 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.

    Device: Ultrasonic · Device: Hand Instruments · Device: LED Source

Interventions

  • DeviceUltrasonic

    Cavitron® BOBCAT® Pro, Dentsply International, USA

  • DeviceHand Instruments

    Gracey, SG 5/6, 7/8, 11/12, 13/14, Hu-Friedy Ins. Co., USA

  • DeviceLED Source

    LED source (625-635 nm wavelength) (FotoSan®, CMS Dental, Denmark)

05

What researchers measure

Primary outcomes

  1. Probing Depth

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

    Time frame: 63 day

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03412331
Lead sponsor
Marmara University
Responsible party
Sponsor
First posted
Jan 26, 2018
Start date
Jan 2008
Primary completion
Jan 2011
Completion
Sep 2012
Last update
Jan 26, 2018

Study contacts

Leyla KURU, Prof. Dr.
study director · Marmara University, Faculty of Dentistry, Department of Periodontology

Oversight

FDA-regulated drug
No
View the source record on ClinicalTrials.gov ↗

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