NCT02801773

Brief Summary

The aim of this randomized placebo- controlled clinical trials is to evaluate the effects of Lactobacillus reuteri containing probiotic lozenges as an adjunct to scaling and root planning (SRP). Material and methods: Thirty six gingivitis patients will be recruited and monitored clinically at baseline, 3 and 6 month after therapy. All patients will receive scaling and periodontal treatment and randomly will be assigned over an experimental (SRP + probiotic, N=18) or control (SRP+ placebo, n=18) group. The lozenges will be used once per day during 3 month.

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
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_2

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, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 16, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 21, 2016

Status Verified

June 1, 2016

Enrollment Period

Same day

First QC Date

June 13, 2016

Last Update Submit

June 18, 2016

Conditions

Gingivitis

Keywords

gingivitisprobioticnon- surgical treatment

Outcome Measures

Primary Outcomes (1)

  • Differences between groups for bleeding on probing changes

    baseline, 1, 3 month

Secondary Outcomes (1)

  • Differences between groups for gingival index

    baseline, 1, 3 month

Study Arms (2)

Treatment Gingivitis with Probiotic

EXPERIMENTAL

Gingivitis group of patient treated with conventional therapy (scaling, coronary polish and oral higiene instruction) and adjunct probiotic one lozenge containig Lactobacillus reuteri per day during 3 month

Dietary Supplement: Treatment Gingivitis with Probiotic

Treatment Gingivitis conventional

PLACEBO COMPARATOR

Gingivitis group of patient treated with conventional therapy (scaling, coronary polish and oral higiene instruction) and one lozenge containig placebo (mint lozenge) per day during 3 month

Other: Treatment Gingivitis conventional

Interventions

Treatment Gingivitis with ProbioticDIETARY_SUPPLEMENT

Gingivitis Treatment (scaling and coronary polish) and one lozenge containing Lactobacillus reuteri per day during 3 months

Treatment Gingivitis with Probiotic
Treatment Gingivitis conventionalOTHER

gingivis treatment (scaling and coronary polish) and and one lozenge containing Placebo (mint lozenge) per day during 3 months

Treatment Gingivitis conventional

Eligibility Criteria

Age17 Years - 28 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis of Gingivitis
  • Gingival index \> 1.5 (\> 10 % of sites examined)
  • Bleeding index \> 10 % sites surveyed
  • Probing Depth \< 4 mm
  • Systemically healthy (except for the presence of gingivitis)
  • Patients who have not received periodontal treatment before the test and no intake of medicines such antibiotic and/ or anti-inflammatory in the last 3 months prior to the start of the study

You may not qualify if:

  • Patient who develop systemic disease during the study
  • Patient who have to ingest antibiotic/ or anti-inflammatories during the study
  • If you are a woman becomes pregnant during 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

RECRUITING

MeSH Terms

Conditions

Gingivitis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Jorge Gamonal Aravena, Proffesor

    Faculty of Dentistry of University of Chile

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joel E Bravo Bown, Proffesor

CONTACT

+5694540294jbravo@odontologia.uchile.cl

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
PRINCIPAL INVESTIGATOR
PI Title
Proffesor

Study Record Dates

First Submitted

June 13, 2016

First Posted

June 16, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

June 21, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)