The Use of a Probiotic Lozenge in the Treatment of Residual Pockets After Classical Non-surgical Therapy
Primary Purpose
Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Probiotic tablet- Biogaia
Placebo tablet
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis
Eligibility Criteria
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
Sites / Locations
- UZLeuven
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Test
Control
Arm Description
Probiotic tablet
Control tablet
Outcomes
Primary Outcome Measures
Pocket Probing Depth (PPD) at teeth with residual pockets
Recessions (REC) at teeth with residual pockets
Clinical Attachment Loss (CAL) at teeth with residual pockets
Secondary Outcome Measures
Plaque at teeth with residual pockets
Bleeding on Probing (BoP) at teeth with residual pockets
Overall PPD, REC, CAL
Microbial samples: deepest pocket, saliva, tongue
Full Mouth Plaque Score (FMPS) and Full Mouth Bleeding Score (FMBS)
Full Information
NCT ID
NCT02490618
First Posted
May 6, 2015
Last Updated
February 11, 2019
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
BioGaia AB
1. Study Identification
Unique Protocol Identification Number
NCT02490618
Brief Title
The Use of a Probiotic Lozenge in the Treatment of Residual Pockets After Classical Non-surgical Therapy
Official Title
The Use of a Probiotic Lozenge in the Treatment of Residual Pockets After Classical Non-surgical Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
BioGaia AB
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test
Arm Type
Experimental
Arm Description
Probiotic tablet
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Control tablet
Intervention Type
Other
Intervention Name(s)
Probiotic tablet- Biogaia
Intervention Type
Other
Intervention Name(s)
Placebo tablet
Primary Outcome Measure Information:
Title
Pocket Probing Depth (PPD) at teeth with residual pockets
Time Frame
3-6 months
Title
Recessions (REC) at teeth with residual pockets
Time Frame
3-6 months
Title
Clinical Attachment Loss (CAL) at teeth with residual pockets
Time Frame
3-6 months
Secondary Outcome Measure Information:
Title
Plaque at teeth with residual pockets
Time Frame
3-6 months
Title
Bleeding on Probing (BoP) at teeth with residual pockets
Time Frame
3-6 months
Title
Overall PPD, REC, CAL
Time Frame
3-6 months
Title
Microbial samples: deepest pocket, saliva, tongue
Time Frame
3-6 months
Title
Full Mouth Plaque Score (FMPS) and Full Mouth Bleeding Score (FMBS)
Time Frame
3-6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
UZLeuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
The Use of a Probiotic Lozenge in the Treatment of Residual Pockets After Classical Non-surgical Therapy
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