Aggressive Periodontitis Clinical Trial
Official title:
Clinical, Microbiological and Immunological Effects of Antimicrobial Photodynamic Therapy on Non-surgical Treatment of Aggressive Periodontitis: a Double-blind Split-mouth Randomized Controlled Clinical Trial.
Verified date | April 2014 |
Source | University of Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: National Committee of Ethics in Research |
Study type | Interventional |
The treatment of aggressive periodontitis (AgP) represents a challenge for clinicians, because there are no standardized protocols for efficient control of the disease. The aim of this study is to evaluate the effect of multiple applications of antimicrobial photodynamic therapy (aPDT) as an adjunct to non-surgical periodontal treatment (nsPT) in patients diagnosed with AgP. Twenty patients with a clinical diagnosis of AgP will be treated in a split-mouth design study to either aPDT associated with scaling and root planning (SRP) or SRP only. aPDT will be performed by using a laser light source with 690 nm wavelength associated with a phenothiazine photosensitizer. The applications will occur in four episodes (days 0, 2, 7 and 14). All patients will be monitored for 90 days. Clinical assessment of plaque index, probing depth, clinical attachment level and bleeding on probing will be performed at baseline (pre-intervention period) and 30 and 90 days after the nsPT. Subgingival plaque samples will be collected (at baseline and 30 and 90 days after the nsPT) and the counts of 40 subgingival species will be determined using DNA-DNA checkerboard hybridization. Gingival crevicular fluid samples will be collected (at baseline and 14, 30 and 90 after the nsTP) for evaluation the volume of fluid (Periotron) and the levels of Interleukin 1 beta, Interleukin 10 and Tumor Necrosis Factor alpha (Luminex). Data obtained will be statistically analyzed.
Status | Completed |
Enrollment | 20 |
Est. completion date | March 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 35 Years |
Eligibility |
Inclusion Criteria: - subjects with <35 years old; - a minimum of 20 teeth present; - two pairs of single-rooted teeth in opposite sides with proximal sites showing probing depth and clinical attachment level = 5 mm. Exclusion Criteria: - Positive history of antibiotic-therapy in the last six months; - Positive history of basic periodontal treatment in the last six months; - Systemic disease that can interfere with the progression of disease or response to treatment (eg, diabetes, immune disorders); - Extensive prosthetic involvement; - Need for antibiotic prophylaxis for performing routine dental procedures; - Use of anti-inflammatory drugs for long periods of time; - Smoking - Pregnancy. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | School of Dentistry of Ribeirao Preto - University of São Paulo | Ribeirão Preto | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo | Fundação de Amparo à Pesquisa do Estado de São Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline in clinical attachment level at +90 days. | The clinical periodontal parameter will be recorded at baseline (pre-intervention) and +90 days after the non-surgical periodontal therapy. | Yes | |
Secondary | Change from baseline in counts of 40 subgingival bacterial species at +30 and +90 days | Microbiological monitoring (at baseline and +30 and +90 days after the non-surgical periodontal therapy) using the checkerboard DNA-DNA hybridization | No | |
Secondary | Change from baseline in levels of IL-1ß, IL-10 and TNF-alpha at +14 and +30 and +90 days | Immunological monitoring (at baseline, +14 and +30 and +90 days after the non-surgical periodontal therapy) using Luminex. | No | |
Secondary | Numbers of patients requiring additional periodontal treatment at +90 days. | Considering each group separately, it will be evaluate the number of patients presenting at least a site with PPD=5 mm and positiveBOP at 90 days post-therapy. | Yes |
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