NCT05107622

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2021

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 16, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 4, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

October 24, 2022

Status Verified

October 1, 2022

Enrollment Period

2.3 years

First QC Date

October 25, 2021

Last Update Submit

October 20, 2022

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

  • Number of pockets with PD ≥ 5 mm

    Number of pockets with probing depth ≥ 5 mm

    6 months

Study Arms (2)

FMUD+Probiotic

EXPERIMENTAL

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

Other: FMUD+Probiotic

FMUD+Placebo

PLACEBO COMPARATOR

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

Other: FMUD+Placebo

Interventions

FMUD+ProbioticOTHER

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

FMUD+Probiotic
FMUD+PlaceboOTHER

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

FMUD+Placebo

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mauro Pedrine Santamaria

São José dos Campos, São Paulo, 12245000, Brazil

RECRUITING

Related Publications (3)

  • 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.

    PMID: 32253208BACKGROUND

  • 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.

    PMID: 29926952BACKGROUND

  • 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.

    PMID: 24164569BACKGROUND

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Laís F Ferraz, MS

    Sao Paulo State University - Brazil

    PRINCIPAL INVESTIGATOR

  • Mauro P Santamaria, PhD

    Sao Paulo State University - Brazil

    STUDY DIRECTOR

Central Study Contacts

Mauro P Santamaria, PhD

CONTACT

(12) 39479055mauro.santamaria@unesp.br

Laís FF Ferraz, MS

CONTACT

(15) 991756747lais.ferraz@hotmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 25, 2021

First Posted

November 4, 2021

Study Start

August 16, 2021

Primary Completion

December 1, 2023

Study Completion

April 1, 2024

Last Updated

October 24, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

Data will be available at the end of the study after a direct request.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
After the study completion.

Locations

BR(1)