Adjunctive Photodynamic Therapy in Treatment of Chronic Periodontitis

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Giorgio De Micheli, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01034501
First received: December 16, 2009
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Chronic Periodontitis
Device: sham procedure
Device: photodynamic therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Adjunctive Photodynamic Therapy in Non-surgical Treatment of Chronic Periodontitis: a Randomized , Controlled Clinical Trial

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Change in mean attachment level [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in probing pocket depth [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in periodontal pathogens(Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola and Aggregatibacter actinomycetencomitans)counts. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: February 2010
Study Completion Date: September 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: photodynamic therapy
photodynamic therapy 660 nm,40 mW,60 Hz
Device: photodynamic therapy
photodynamic therapy 660 nm,40 mW,60 Hz
Other Name: Laser Hand - MM Optics (ANVISA: 80051420009)
Sham Comparator: sham procedure
Not activation of laser device
Device: sham procedure
non activated laser tip
Other Name: Laser Hand - MM Optics (ANVISA: 80051420009)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034501

Locations
Brazil
Faculdade de Odontologia da Universidade de São Paulo (FOUSP)
São Paulo, SP, Brazil, 05508-000
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Giorgio De Micheli, Professor FOUSP
  More Information

Publications:
Responsible Party: Giorgio De Micheli, Associated, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01034501     History of Changes
Other Study ID Numbers: CEP2112008
Study First Received: December 16, 2009
Last Updated: October 9, 2013
Health Authority: Brazil: Ministry of Health

Keywords provided by University of Sao Paulo:
periodontitis
photodynamic therapy

Additional relevant MeSH terms:
Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on April 16, 2014