NCT05107622

Administration of L. Paracasei 28.4 as an Adjunct to the Treatment of Periodontitis

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to evaluate the effects of probiotic administration of L. paracasei 28.4 as an adjunct to the non-surgical periodontal treatment in patients with periodontitis.

Detailed description

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. All clinical measurements will be performed by a single researcher, previously calibrated for the measurements. After periodontal therapy, treatment results will be evaluated three and six months after periodontal debridement associated with the use of placebo/probiotic formulation. Indications of adverse oral effects will be verified by visual assessment at 7, 30 and 90 days after the start of consumption of formulations. To assess patient-centered parameters, the OHIP-14 questionnaire will be applied before and after 6 months of periodontal treatment for each patient. A 30-days diary will be used to assess the adherence to use and occurrence adverse effects. Microbiological and immunological analyzes will be carried out through subgingival biofilm and gingival crevicular fluid samples collected from sites with moderate pockets and sites with deep pockets at baseline, 3 and 6 months after therapy.

Conditions

• Periodontitis

Interventions

Type	Name	Description
OTHER	FMUD+Probiotic	Full-mouth ultrasonic periodontal debridement associated with administration of probiotic formulation (Lactobacillus paracasei 28.4) twice a day for 30 days.
OTHER	FMUD+Placebo	Full-mouth ultrasonic periodontal debridement associated with administration of placebo formulation twice a day for 30 days.

Timeline

• Start date: 2021-08-16
• Primary completion: 2023-12-01
• Completion: 2024-04-01
• First posted: 2021-11-04
• Last updated: 2022-10-24

Locations

1 site across 1 country: Brazil