Longitudinal evaluation of two non-surgical periodontal therapies: a randomized controlled clinical trial

Abstract

Hypothesis: (1) the conventional non-surgical periodontal therapy is more effectiveness than the protocol designed full-mouth disinfection in generalized advanced chronic periodontitis (2) the systemic use of Azithromycin provide clinical and microbial benefits in comparison of non-surgical periodontal therapy alone. The first aim of this randomized controlled clinical trial will be test in a short period of time the effectiveness of conventional non-surgical periodontal therapy versus full-mouth disinfection with the use of 3 days systemic Azithromycin. The second aim will be compare by quantitative polymerase chain reaction (qPCR) the levels of red complex bacteria (P. gingivalis, T. forsythia, T. denticola). All clinical and microbial exams will be done at baseline and 90 days in both treatment. Methods: The main sample will consist of sixty subjects randomly allocated in 4 groups: conventional non-surgical periodontal therapy+systemic Azithromycin (15 subjects); conventional non-surgical periodontal therapy alone ((15 subjects); full-mouth+systemic Azithromycin (15 subjects) and full-mouth alone (15 subjects). Longitudinal clinical examinations including PPD, CAL, PI and GI will be performed during the trial as to compare the effectiveness of the protocols. Quantitative evaluations of oral microorganisms such as P. gingivalis, T. forsythia and T. denticola will be also done. Results will be analyzed through measures of central tendency, confidence interval and standard deviation for the descriptive data. To consider the final variables as well as variables of treatment, parametric and nonparametric statistics will be used. The development of the study might be confirm or refute the hypothesis then serve to select better protocols to treat generalized advanced chronic periodontitis.