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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02490618
• Other study ID #: s57667
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: January 2019
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

Other:
• Probiotic tablet- Biogaia

• Placebo tablet

Locations

Country	Name	City	State
Belgium	UZLeuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	BioGaia AB

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pocket Probing Depth (PPD) at teeth with residual pockets		3-6 months
Primary	Recessions (REC) at teeth with residual pockets		3-6 months
Primary	Clinical Attachment Loss (CAL) at teeth with residual pockets		3-6 months
Secondary	Plaque at teeth with residual pockets		3-6 months
Secondary	Bleeding on Probing (BoP) at teeth with residual pockets		3-6 months
Secondary	Overall PPD, REC, CAL		3-6 months
Secondary	Microbial samples: deepest pocket, saliva, tongue		3-6 months
Secondary	Full Mouth Plaque Score (FMPS) and Full Mouth Bleeding Score (FMBS)		3-6 months