Administration of L. Paracasei 28.4 as an Adjunct to the Treatment of Periodontitis: Superiority Placebo-controlled Randomized Clinical Trial

This is a superiority placebo-controlled randomized clinical trial. The population that will be evaluated in the study will be selected at Institute of Science and Technology (ICT), São José dos Campos, College of Dentistry.

Sixty patients presenting Stage III/IV and Grade B/C periodontitis will be divided into 2 groups:

• FMUD+Placebo (n=30): full-mouth ultrasonic periodontal debridement associated with administration of placebo formulation, twice a day for 30 days;
• FMUD+Probiotic (n=30): full-mouth ultrasonic periodontal debridement associated with administration of probiotic formulation twice a day for 30 days.

The study will consist of two stages of treatment:

• Initial therapy: Before starting treatment, a complete examination of the oral cavity and evaluation of periodontal parameters will be performed. All patients will undergo a prior adjustment of the oral environment and oral hygiene. Thirty days after completion of initial therapy, a new periodontal evaluation will be performed and only patients who present a visible plaque index less than or equal to 25% will undergo subgingival periodontal debridement.
• Non-surgical periodontal therapy: After initial therapy, all patients will receive full-mouth ultrasonic periodontal debridement. Debridement will be performed by a single operator, trained, blind to the allocation of patients and different from the evaluator. If there is any complication that prevents the completion of full-mouth debridement, the procedure will be finished within a maximum period of 24 hours. The randomization envelope will be opened and the probiotic/placebo formulation will be delivered to patients. They will be instructed to consume the samples twice a day during the 30 days following periodontal treatment.