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

NCT ID: NCT05107622

Last Updated: 2022-10-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-16
• Study Completion Date: 2024-04-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

FMUD+Probiotic

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

Group Type: EXPERIMENTAL

FMUD+Probiotic

Intervention Type: OTHER

Full-mouth ultrasonic periodontal debridement associated with administration of probiotic formulation (Lactobacillus paracasei 28.4) twice a day for 30 days.

FMUD+Placebo

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

Group Type: PLACEBO_COMPARATOR

FMUD+Placebo

Intervention Type: OTHER

Full-mouth ultrasonic periodontal debridement associated with administration of placebo formulation twice a day for 30 days.

Interventions

FMUD+Probiotic

Full-mouth ultrasonic periodontal debridement associated with administration of probiotic formulation (Lactobacillus paracasei 28.4) twice a day for 30 days.

Intervention Type: OTHER

FMUD+Placebo

Full-mouth ultrasonic periodontal debridement associated with administration of placebo formulation twice a day for 30 days.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosis of stage III/IV and grade B/C generalized periodontitis;
• Presence of at least 20 teeth in the mouth;
• Signing the informed consent form.

Exclusion Criteria

• Presence of systemic conditions that contraindicate the periodontal procedure or influence the progression of the disease;
• Periodontal treatment history in the last six months;
• Use of antibiotics or probiotics in the last six months;
• Smoke more than 10 cigarettes a day;
• Pregnant or breastfeeding;
• Chronic use of anti-inflammatory drugs or medications that can alter the response of periodontal tissues;
• Need of antibiotic prophylaxis for dental procedures;
• Need of probiotic therapy.

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Estadual Paulista Júlio de Mesquita Filho

OTHER

Sponsor Role: lead

Responsible Party

Mauro Pedrine Santamaria

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laís F Ferraz, MS

Role: PRINCIPAL_INVESTIGATOR

Sao Paulo State University - Brazil

Mauro P Santamaria, PhD

Role: STUDY_DIRECTOR

Sao Paulo State University - Brazil

Locations

Mauro Pedrine Santamaria

São José dos Campos, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Mauro P Santamaria, PhD

Role: CONTACT

mauro.santamaria@unesp.br

(12) 39479055 ext. +55

Laís FF Ferraz, MS

Role: CONTACT

lais.ferraz@hotmail.com

(15) 991756747 ext. +55

Facility Contacts

Laís FF Ferraz, MS

Role: primary

lais.ferraz@hotmail.com

(15) 991756747 ext. +55

References

Ribeiro FC, Junqueira JC, Dos Santos JD, de Barros PP, Rossoni RD, Shukla S, Fuchs BB, Shukla A, Mylonakis E. Development of Probiotic Formulations for Oral Candidiasis Prevention: Gellan Gum as a Carrier To Deliver Lactobacillus paracasei 28.4. Antimicrob Agents Chemother. 2020 May 21;64(6):e02323-19. doi: 10.1128/AAC.02323-19. Print 2020 May 21.

Reference Type: BACKGROUND

PMID: 32253208 (View on PubMed)

Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.

Reference Type: BACKGROUND

PMID: 29926952 (View on PubMed)

Teughels W, Durukan A, Ozcelik O, Pauwels M, Quirynen M, Haytac MC. Clinical and microbiological effects of Lactobacillus reuteri probiotics in the treatment of chronic periodontitis: a randomized placebo-controlled study. J Clin Periodontol. 2013 Nov;40(11):1025-35. doi: 10.1111/jcpe.12155. Epub 2013 Sep 15.

Reference Type: BACKGROUND

PMID: 24164569 (View on PubMed)

Other Identifiers

Lp + PD

Identifier Type: -

Identifier Source: org_study_id