The Use of a Probiotic Lozenge in the Treatment of Peri-implantitis

Peri-implantitis Clinical Trial

Official title:

The Use of a Probiotic Lozenge in the Treatment of Peri-implantitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02520401
• Other study ID #: s57668
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: December 2018

Study information

• Verified date: January 2018
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This studies aims to investigate the effect of a probiotics in peri-implantitis patients as an adjunct to non-surgical therapy.

Description:

This studies aims to investigate the effect of a probiotics in peri-implantitis patients as an adjunct to non-surgical therapy.

Study design: This study will be a single centre (Department of Oral Health Sciences, University Hospitals Leuven), double blind randomized, placebo controlled clinical trial. 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 departement of Periodontology at the University Hospital Leuven, with peri-implantitis and who fit the inclusion criteria will be asked to participate in this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• 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:

• >18 years of age

• Patients with at least one implant* diagnosed with initial peri-implantitis.

• Willing and able to give written informed consent

• No signs of acute periodontitis

• presence of keratinized tissue around treated implant(s)

Exclusion Criteria:

• patients who smoke

• patients with periodontitis

• pregnant or lactating woman

• patients with poorly controlled diabetes

• patients taking bisphosphonate mediation

• patient who had taken systemic antibiotics 3 months prior to treatment

• peri-implantitis treatment 12 months prior intake

Related Conditions & MeSH terms

• Peri-implantitis

Intervention

Other:
• Probiotic - BioGaia
Use of a probiotic tablet
• Placebo
Use of a 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	Probing Pocket Depth (PPD) at peri-implantitis sites	Pocket probing depth measured with Merrit-B probe	Baseline - 6 months
Secondary	Bleeding on Probing (BoP) at peri-implantitis sites	Binairy outcome: 0: no bleeding, 1: bleeding	Baseline - 6 months
Secondary	Plaque at peri-implantitis sites	Binairy outcome: 0: no plaque, 1: plaque	Baseline - 6 months
Secondary	Microbial samples	Of tongue coating, saliva and peri-implantitis site	Baseline - 6 months
Secondary	Full mouth plaque score (FMPS)	Binairy outcome: 0: no plaque, 1: plaque	Baseline - 6 months