The Use of a Probiotic Lozenge in the Treatment of Residual Pockets After Classical Non-surgical Therapy

February 11, 2019 updated by: Universitaire Ziekenhuizen KU Leuven
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 following scaling and rootplaning. Simultaneously the additional benefit of subgingival application of probiotics via oil drops will be investigated.

Recruitment: This study will be a single centre (Department of Oral Health Sciences, University Hospitals Leuven), double blind, randomized, placebo controlled clinical trial with within each patient a split mouth design. The randomization (by means of a computer program) and double blind design are thought to minimize the bias of the investigator and patients.

Selection of the study population: Adults, who consult at the department of Periodontology at the University Hospital Leuven, and who fit the inclusion criteria will be asked to participate in this study.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZLeuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 40 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test
Probiotic tablet
Other: Probiotic tablet- Biogaia
Placebo Comparator: Control
Control tablet
Other: Placebo tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pocket Probing Depth (PPD) at teeth with residual pockets
Time Frame: 3-6 months
3-6 months
Recessions (REC) at teeth with residual pockets
Time Frame: 3-6 months
3-6 months
Clinical Attachment Loss (CAL) at teeth with residual pockets
Time Frame: 3-6 months
3-6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Plaque at teeth with residual pockets
Time Frame: 3-6 months
3-6 months
Bleeding on Probing (BoP) at teeth with residual pockets
Time Frame: 3-6 months
3-6 months
Overall PPD, REC, CAL
Time Frame: 3-6 months
3-6 months
Microbial samples: deepest pocket, saliva, tongue
Time Frame: 3-6 months
3-6 months
Full Mouth Plaque Score (FMPS) and Full Mouth Bleeding Score (FMBS)
Time Frame: 3-6 months
3-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

BioGaia AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

May 6, 2015

First Submitted That Met QC Criteria

July 1, 2015

First Posted (Estimate)

July 7, 2015

Study Record Updates

Last Update Posted (Actual)

February 12, 2019

Last Update Submitted That Met QC Criteria

February 11, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s57667

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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