Clinical trial NCT01034501: Adjunctive Photodynamic Therapy in Treatment of Chronic Periodontitis
Official title: Efficacy of Adjunctive Photodynamic Therapy in Non-surgical Treatment of Chronic Periodontitis: a Randomized , Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Periodontitis
Keywords: periodontitis
photodynamic therapy
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2009-12-17
Enrollment: 38
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in mean attachment level
timeFrame: 12 months
Secondary outcomes:
measure: Change in probing pocket depth
timeFrame: 12 months
measure: Change in periodontal pathogens(Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola and Aggregatibacter actinomycetencomitans)counts.
timeFrame: 12 months
measure: Change in fluid inflammatory markers (Il-1B, Il-6, Il-8, PGE2, TNF-a, Il-10, MMP-2, TIMP-1, MMP-8)
timeFrame: 12 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Faculdade de Odontologia da Universidade de São Paulo (FOUSP)
state: SP
Study officials:
affiliation: FOUSP
name: Giorgio De Micheli, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Christodoulides N, Nikolidakis D, Chondros P, Becker J, Schwarz F, Rossler 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.
citation: 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.
citation: Carvalho VF, Andrade PV, Rodrigues MF, Hirata MH, Hirata RD, Pannuti CM, De Micheli G, Conde MC. Antimicrobial photodynamic effect to treat residual pockets in periodontal patients: a randomized controlled clinical trial. J Clin Periodontol. 2015 May;42(5):440-7. doi: 10.1111/jcpe.12393. Epub 2015 Apr 22.