Clinical Trial: Treatment of Aggressive Periodontitis With Repeated Adjunctive Antimicrobial Photodynamic Therapy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Clinical, Microbiological and Immunological Effects of Antimicrobial Photodynamic Therapy on Non-surgical Treatment of Aggressive Periodontitis: a Double-blind Split-mouth

Brief Summary: 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.

Detailed Summary:

Non-Surgical Periodontal Therapy

Seven days prior to the non-surgical periodontal therapy, periapical radiographs will be taken from the whole mouth of all patients. They will be set in an oral hygiene program (OHP) according to their specific needs. In this program, patients will be instructed about an effective self-performed plaque control, including information about the Bass Technique (Bass, 1954) and interproximal cleaning with dental floss and interdental brushes. They will be also motivated to brush the dorsal surface of the tongue once a day and will receive a dentifrice that shall be used throughout the experimental period (Colgate Total®, Anakol Ind. Com Ltda - Brazil's Kolynos - Colgate Palmolive Co., Sao Bernardo do Campo, SP, Brazil). After the OHP, subjects will undergo the assessment of clinical periodontal parameters previously described and the collection of subgingival plaque and GCF in selected sites (baseline) will be performed. Shortly, patients will receive supragingival scaling and coronal polishing with prophy cup on all the teeth present in the oral cavity. The non-surgical periodontal therapy will initiate 7 days after the OHP and initial supragingival scaling. Within 24 hours, a specialist in Periodontics will perform supra and subgingival scaling and root planing of all teeth with periodontal involvement, using hand (Gracey Curettes, Hu-Friedy, Chicago, IL, USA) and ultrasonic instruments. The instrumentation will be performed on each quadrant until achievement of an adequate cleaning and root planing, which will be verified with a dental explorer. Individuals will receive professional prophylaxis biweekly during three months after the end of the nonsurgical periodontal therapy. On biweekly follow-up visits, patient's cooperation will be monitored by verifying the status of oral hygiene.

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Sponsor: University of Sao Paulo

Current Primary Outcome: Change from Baseline in clinical attachment level at +90 days. [ Time Frame: The clinical periodontal parameter will be recorded at baseline (pre-intervention) and +90 days after the non-surgical periodontal therapy. ]

Original Primary Outcome: Change from Baseline in relative clinical attachment level at +30 and +90 days [ Time Frame: The clinical periodontal parameter will be recorded at baseline (pre-intervention) and +30 and +90 days after the non-surgical periodontal therapy. ]

Current Secondary Outcome:

  • Change from baseline in counts of 40 subgingival bacterial species at +30 and +90 days [ Time Frame: Microbiological monitoring (at baseline and +30 and +90 days after the non-surgical periodontal therapy) using the checkerboard DNA-DNA hybridization ]
  • Change from baseline in levels of IL-1β, IL-10 and TNF-alpha at +14 and +30 and +90 days [ Time Frame: Immunological monitoring (at baseline, +14 and +30 and +90 days after the non-surgical periodontal therapy) using Luminex. ]
  • Numbers of patients requiring additional periodontal treatment at +90 days. [ Time Frame: 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. ]


Original Secondary Outcome:

  • Change from baseline in counts of 40 subgingival bacterial species at +30 and +90 days [ Time Frame: Microbiological monitoring (at baseline and +30 and +90 days after the non-surgical periodontal therapy) using the checkerboard DNA-DNA hybridization ]
  • Change from baseline in levels of IL-1β, IL-10 and TNF-alpha at +14 and +30 and +90 days [ Time Frame: Immunological monitoring (at baseline, +14 and +30 and +90 days after the non-surgical periodontal therapy) using Luminex. ]


Information By: University of Sao Paulo

Dates:
Date Received: December 9, 2013
Date Started: January 2013
Date Completion:
Last Updated: April 2, 2014
Last Verified: April 2014