Adjunctive Photodynamic Therapy in Treatment of Chronic Periodontitis

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01034501
• Other study ID #: CEP2112008
• Status: Completed
• Phase: Phase 4
• First received: December 16, 2009
• Last updated: October 9, 2013
• Start date: February 2010
• Est. completion date: September 2013

Study information

• Verified date: October 2013
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Device:
• sham procedure
non activated laser tip
• photodynamic therapy
photodynamic therapy 660 nm,40 mW,60 Hz

Locations

Country	Name	City	State
Brazil	Faculdade de Odontologia da Universidade de São Paulo (FOUSP)	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

Braun A, Dehn C, Krause F, Jepsen S. Short-term clinical effects of adjunctive antimicrobial photodynamic therapy in periodontal treatment: a randomized clinical trial. J Clin Periodontol. 2008 Oct;35(10):877-84. doi: 10.1111/j.1600-051X.2008.01303.x. Epub 2008 Aug 17. — View Citation

Christodoulides N, Nikolidakis D, Chondros P, Becker J, Schwarz F, Rössler R, Sculean A. Photodynamic therapy as an adjunct to non-surgical periodontal treatment: a randomized, controlled clinical trial. J Periodontol. 2008 Sep;79(9):1638-44. doi: 10.1902/jop.2008.070652 . — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean attachment level		12 months	No
Secondary	Change in probing pocket depth		12 months	No
Secondary	Change in periodontal pathogens(Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola and Aggregatibacter actinomycetencomitans)counts.		12 months	No
Secondary	Change in fluid inflammatory markers (Il-1B, Il-6, Il-8, PGE2, TNF-a, Il-10, MMP-2, TIMP-1, MMP-8)		12 months	No