Clinical trial NCT02490618: 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
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: BioGaia AB
First posted: 2015-07-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pocket Probing Depth (PPD) at teeth with residual pockets
timeFrame: 3-6 months
measure: Recessions (REC) at teeth with residual pockets
timeFrame: 3-6 months
measure: Clinical Attachment Loss (CAL) at teeth with residual pockets
timeFrame: 3-6 months
Secondary outcomes:
measure: Plaque at teeth with residual pockets
timeFrame: 3-6 months
measure: Bleeding on Probing (BoP) at teeth with residual pockets
timeFrame: 3-6 months
measure: Overall PPD, REC, CAL
timeFrame: 3-6 months
measure: Microbial samples: deepest pocket, saliva, tongue
timeFrame: 3-6 months
measure: Full Mouth Plaque Score (FMPS) and Full Mouth Bleeding Score (FMBS)
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZLeuven
Study officials:
References: