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

Not Applicable

Completed

• Conditions: Periodontitis
• Interventions: Other: Probiotic tablet- Biogaia; Other: Placebo tablet

• Registration Number: NCT02490618
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Study First Submitted: 2015-05-06
• Study First Submitted QC: 2015-07-01
• Study First Posted: 2015-07-07
• Study Start: 2016-01
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-02-11
• Last Update Posted: 2019-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test	Probiotic tablet- Biogaia	Probiotic tablet
Control	Placebo tablet	Control tablet

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Overall PPD, REC, CAL	3-6 months
Plaque at teeth with residual pockets	3-6 months
Bleeding on Probing (BoP) at teeth with residual pockets	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

Trial Locations

Locations (1)

UZLeuven; 🇧🇪 Leuven, Belgium