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OpenTrials
Completed

NCT Number: NCT03412331

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasonic

Device

Cavitron® BOBCAT® Pro, Dentsply International, USA

Hand Instruments

Device

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

LED Source

Device

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

Primary outcomes

  1. Probing Depth

    Time frame: 63 day

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

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Clinical And Microbiological Evaluations Of Adjunctive Photodynamic Therapy To Non-Surgical Periodontal Treatment In Patients With Generalized Aggressive Periodontitis

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Jan 26, 2018
Registry last updated
Jan 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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