NCT02490618

Brief Summary

The aim of this study is to determine the efficacy of the usage of a probiobitc lozenge in patients with residual bleeding pockets of ≥ 5mm 3 months following scaling and rootplaning. Simultaneously the additional benefit of subgingival application of probiotics via oil drops will be investigated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 7, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 12, 2019

Status Verified

January 1, 2019

Enrollment Period

2.9 years

First QC Date

May 6, 2015

Last Update Submit

February 11, 2019

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (3)

  • Pocket Probing Depth (PPD) at teeth with residual pockets

    3-6 months

  • Recessions (REC) at teeth with residual pockets

    3-6 months

  • Clinical Attachment Loss (CAL) at teeth with residual pockets

    3-6 months

Secondary Outcomes (5)

  • Plaque at teeth with residual pockets

    3-6 months

  • Bleeding on Probing (BoP) at teeth with residual pockets

    3-6 months

  • Overall PPD, REC, CAL

    3-6 months

  • Microbial samples: deepest pocket, saliva, tongue

    3-6 months

  • Full Mouth Plaque Score (FMPS) and Full Mouth Bleeding Score (FMBS)

    3-6 months

Study Arms (2)

Test

EXPERIMENTAL

Probiotic tablet

Other: Probiotic tablet- Biogaia

Control

PLACEBO COMPARATOR

Control tablet

Other: Placebo tablet

Interventions

Probiotic tablet- BiogaiaOTHER
Test
Placebo tabletOTHER
Control

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients
  • ≥ 18 years of age
  • scaling and rootplaning received at least 3 months ago
  • Patients diagnosed with residual pockets (at least 2), with the definition of residual pockets:\> 5mm or 5 and BOP+
  • Willing and able to give written informed consent

You may not qualify if:

  • patients with aggressive periodontitis
  • patients who smoke
  • pregnant or lactating woman
  • patients with poorly controlled diabetes
  • patients taking bisphosphonate mediation
  • patient who had taken systemic antibiotics 3 months prior to treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZLeuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2015

First Posted

July 7, 2015

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

February 12, 2019

Record last verified: 2019-01

Locations

BE(1)