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Completed

NCT Number: NCT01034501

Adjunctive Photodynamic Therapy in Treatment of Chronic Periodontitis

The aim of this study is to verify the efficacy of Photodynamic Therapy (PDT) as an adjunct to non-surgical treatment of chronic periodontitis by assessing clinical and microbiological and immunological parameters. This is a randomized, controlled, double-blind, parallel clinical trial. Thirty eight patients with chronic periodontitis will receive conventional periodontal treatment. After eight weeks, patients will be re-evaluated and sites with residual pockets (PD ≥ 5 mm ) will be selected as experimental sites, and will be allocated to test and control group randomly. The test group will receive the application of PDT and the control group will receive sham procedure. The clinical parameters will be evaluated at baseline, 3, 6 and 12 months after treatment. Subgingival plaque will be collected before PDT, a week after, 3, 6 and 12 months later. The microbiological evaluation will detect and quantify periodontal pathogens such as Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola and Aggregatibacter actinomycetencomitans with real time-PCR. During follow-up, patients will receive periodontal maintenance every 3 months, as well as the application of PDT or sham

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Key information

Conditions

Chronic Periodontitis Chronic Disease Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculdade de Odontologia da Universidade de São Paulo (FOUSP)

São Paulo, 05508-000, Brazil

About this study

The goal of periodontal treatment is to restore tissue health through the elimination and control of etiologic factors, reducing the microbial aggression. Some microorganisms persist in the root surface even after scraping. Thus, the conventional mechanical treatment may fail to reduce the number of periodontal pathogens to levels compatible with health. This study will verify the efficacy of Photodynamic Therapy (PDT) as an adjunct to non-surgical treatment of chronic periodontitis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chronic Periodontitis (Tonetti, Claffey, 2005)
  • 10 or more teeth
  • 2 or more site with probing pocket depth ≥ 5 mm, with or without bleeding on probing, after re-evaluation

Exclusion criteria

  • Profilatic antibiotics
  • Diabetes, immunosuppression, pregnancy nursing mother
  • Smoking
  • Medication that might interfere with periodontal healing
  • Previous periodontal treatment or antibiotics (6 months)
  • Experimental teeth with mobility II or III, or endodontic problem

Treatment and study plan

Sham Procedure

Device

non activated laser tip

Other names: Laser Hand - MM Optics (ANVISA: 80051420009)

Photodynamic therapy

Device

photodynamic therapy 660 nm,40 mW,60 Hz

Other names: Laser Hand - MM Optics (ANVISA: 80051420009)

Primary outcomes

  1. Change in mean attachment level

    Time frame: 12 months

Secondary outcomes

  1. Change in probing pocket depth

    Time frame: 12 months

  2. Change in periodontal pathogens(Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola and Aggregatibacter actinomycetencomitans)counts.

    Time frame: 12 months

  3. Change in fluid inflammatory markers (Il-1B, Il-6, Il-8, PGE2, TNF-a, Il-10, MMP-2, TIMP-1, MMP-8)

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Efficacy of Adjunctive Photodynamic Therapy in Non-surgical Treatment of Chronic Periodontitis: a Randomized , Controlled Clinical Trial

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Dec 17, 2009
Registry last updated
Oct 10, 2013

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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