NCT02283736

Brief Summary

The aim of this randomized placebo- controlled clinical trial is to evaluate the effects of Lactobacillus rhamnosus SP1- containing probiotic tablets as an adjunct to scaling and root planning (SRP). Material and methods: Thirty six chronic periodontitis patients will be recruited and monitored clinically, immunologically and microbiologically at baseline, 3 and 6 months after therapy. All patients will receive scaling and root planning and randomly will be assigned over an experimental (SRP + probiotic, n=18) or control (SRP + placebo, n=18) group. The tablets will be used once per day during 3 months.

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
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2014

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

June 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 5, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 15, 2016

Status Verified

June 1, 2016

Enrollment Period

1 year

First QC Date

November 1, 2014

Last Update Submit

June 13, 2016

Conditions

-Chronic Periodontitis

Keywords

Chronic periodontitisProbioticsNon- surgical treatment

Outcome Measures

Primary Outcomes (1)

  • Differences of at least 1mm between groups for clinical attachment level changes

    baseline, 3, 6 months

Secondary Outcomes (5)

  • Differences between groups for probing depth changes

    baseline, 3, 6 month

  • Differences between groups for bleeding on probing changes

    baseline, 3, 6 months

  • Differences between groups for plaque index changes

    baseline, 3, 6 months

  • Differences between groups for levels of Interleukin (IL)-17, IL-21, Transforming Growth Factor (TGF)- beta, IL-10, RANKL changes in gingival crevicular fluid

    baseline, 3, 6 months

  • Differences between groups for levels of periodontal pathogens changes

    baseline, 3, 6 months

Study Arms (2)

Periodontal treatment, Probitic

EXPERIMENTAL

Periodontal treatment (scaling and root planning) and one tablet containing Lactobacillus rhamnosus SP1 per day during 3 months.

Other: Lactobacillus rhamnosus SP1Procedure: Periodontal treatment

Periodontal treatment, talc powder tab

PLACEBO COMPARATOR

Periodontal treatment (scaling and root planning) and one tablet containing talc powder per day during 3 months

Other: Talc powderProcedure: Periodontal treatment

Interventions

Lactobacillus rhamnosus SP1OTHER

Tablet containing Lactobacillus rhamnosus SP1

Periodontal treatment, Probitic
Talc powderOTHER

Tablet containing talc powder

Periodontal treatment, talc powder tab
Periodontal treatmentPROCEDURE

Scaling and root planning

Periodontal treatment, ProbiticPeriodontal treatment, talc powder tab

Eligibility Criteria

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

You may qualify if:

  • ≥14 natural teeth, excluding third molars
  • ≥10 posterior teeth
  • ≥35 years old
  • ≥ 5 teeth with periodontal sites with probing depths ≥5mm, clinical attachment loss ≥3mm
  • Bleeding on probing ≥20% of sites
  • Extensive bone loss determined radiographically

You may not qualify if:

  • Periodontal treatment before the time of examination
  • Systemic illness
  • Pregnancy
  • Anticoagulant, antibiotics and non- steroid anti- inflammatory therapy in the 6-month period before the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry of University of Chile

Santiago, Santiago Metropolitan, Chile

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Dimethyl SulfoxidePeriodontal Index

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfoxidesSulfur CompoundsOrganic ChemicalsDental Health SurveysHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDentistryPeriodonticsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Dentistry

Study Officials

  • Jorge Gamonal, Professor

    Faculty of Dentistry of University of Chile

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 1, 2014

First Posted

November 5, 2014

Study Start

June 1, 2014

Primary Completion

June 1, 2015

Study Completion

December 1, 2016

Last Updated

June 15, 2016

Record last verified: 2016-06

Locations

CL(1)