Evaluation of Antimicrobial Photodynamic Therapy in Multiple Applications as a Coadjuvant in the Surgical Therapy of Access to Scaling
NCT03498404 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2018-04-13
Summary
Chronic periodontitis is an infectious disease resulting in inflammation of the teeth support structures, progressive periodontal attachment loss and bone loss. The aim of this study is to evaluate the effects of antimicrobial photodynamic therapy (TFDA) in multiple applications as an adjunct to surgical periodontal therapy in patients with generalized severe chronic periodontitis. A total of twenty patients will be submitted to this split-mouth trial, receiving initial periodontal basic nonsurgical treatment that is scaling and root planing. After the sites are indicated for surgical therapy, they receive surgical access therapy associated with scaling and root planing and TfdA using the treatment protocol during periods of 0, 7, 14 and 30 postoperative days, or only surgical access therapy associated with scaling and root planing. As protocol, TfdA will be used laser light source 660nm wavelength in combination with phenothiazine, a photosensitizer with 10 seconds of exposure per site during surgery and 60 seconds in other applications. All patients will be oral hygiene care and follow-up for 90 days. In the baseline period, basic post-therapy, 30 and 90 days after surgical therapy will be performed the clinical evaluation of plaque index, depth of probing pocket, level of clinical insertion relative and bleeding on probing, beyond the collection plate samples subgingival 40 for counting microbial species using the method of DNA-DNA hybridization checkerboard. For the same periods are also collected samples of gingival crevicular fluid for evaluating fluid volume (Periotron) and the levels of Interleukin 1 beta, Interleukin 10, MMP-8, tumor necrosis factor alpha, RANK-L and Osteoprotegerin (OPG). The data are statistically analyzed with the tests to the sample.
Conditions
- Chronic Periodontitis
Interventions
- RADIATION
-
Photodynamic Therapy
After the sites are indicated for surgical therapy, they receive surgical access therapy associated with scaling and root planing and TfdA using the treatment protocol during periods of 0, 7, 14 and 30 postoperative days, or only surgical access therapy associated with scaling and root planing. As protocol, TfdA will be used laser light source 660nm wavelength in combination with phenothiazine, a photosensitizer with 10 seconds of exposure per site during surgery and 60 seconds in other applications.
- OTHER
-
scaling and root planing
Scaling and root planing, also known as conventional periodontal therapy, or deep cleaning, is a procedure involving removal of dental plaque and calculus (scaling or debridement) and then smoothing, or planing, of the (exposed) surfaces of the roots, removing cementum or dentine that is impregnated with calculus, toxins, or microorganisms, the etiologic agents that cause inflammation. This helps to establish a periodontium that is in remission of periodontal disease. Periodontal scalers and periodontal curettes are some of the tools involved.
Sponsors & Collaborators
-
Uislen Berian Cadore
collaborator UNKNOWN -
University of Sao Paulo
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 35 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-04-07
- Primary Completion
- 2018-04-07
- Completion
- 2018-04-07
Countries
- Brazil
Study Locations
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