Adjunctive Photodynamic Therapy in Treatment of Chronic Periodontitis

Phase 4

Completed

• Conditions: Chronic Periodontitis
• Interventions: Device: photodynamic therapy; Device: sham procedure

• Registration Number: NCT01034501
• Lead Sponsor: University of Sao Paulo

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2009-12-16
• Study First Submitted QC: 2009-12-16
• Study First Posted: 2009-12-17
• Study Start: 2010-02
• Primary Completion: 2013-08
• Study Completion: 2013-09
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-09
• Last Update Posted: 2013-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
photodynamic therapy	photodynamic therapy	photodynamic therapy 660 nm,40 mW,60 Hz
sham procedure	sham procedure	Not activation of laser device

Primary Outcome Measures

Name	Time	Method
Change in mean attachment level	12 months

Secondary Outcome Measures

Name	Time	Method
Change in probing pocket depth	12 months
Change in fluid inflammatory markers (Il-1B, Il-6, Il-8, PGE2, TNF-a, Il-10, MMP-2, TIMP-1, MMP-8)	12 months
Change in periodontal pathogens(Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola and Aggregatibacter actinomycetencomitans)counts.	12 months

Trial Locations

Locations (1)

Faculdade de Odontologia da Universidade de São Paulo (FOUSP); 🇧🇷 São Paulo, SP, Brazil