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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| photodynamic therapy | Active Comparator | photodynamic therapy 660 nm,40 mW,60 Hz |
|
| sham procedure | Sham Comparator | Not activation of laser device |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sham procedure | Device | non activated laser tip |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Change in mean attachment level | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in probing pocket depth | 12 months | |
| Change in periodontal pathogens(Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola and Aggregatibacter actinomycetencomitans)counts. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giorgio De Micheli, Professor | FOUSP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculdade de Odontologia da Universidade de São Paulo (FOUSP) | São Paulo | São Paulo | 05508-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18771363 | Background | 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. | |
| 18713259 | Background | 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. |
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| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D010778 | Photochemotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D010789 | Phototherapy |
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| photodynamic therapy | Device | photodynamic therapy 660 nm,40 mW,60 Hz |
|
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| Change in fluid inflammatory markers (Il-1B, Il-6, Il-8, PGE2, TNF-a, Il-10, MMP-2, TIMP-1, MMP-8) | 12 months |
| 25808980 | Derived | 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. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |