Adjunctive Photodynamic Therapy in Treatment of Chronic Periodontitis

U

University of Sao Paulo

Status and phase

Completed
Phase 4

Conditions

Chronic Periodontitis

Treatments

Device: sham procedure
Device: photodynamic therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01034501
CEP2112008

Details and patient eligibility

About

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

Full 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.

Enrollment

38 patients

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

38 participants in 2 patient groups

photodynamic therapy
Active Comparator group
Description:
photodynamic therapy 660 nm,40 mW,60 Hz
Treatment:
Device: photodynamic therapy
sham procedure
Sham Comparator group
Description:
Not activation of laser device
Treatment:
Device: sham procedure

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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