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

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Peri-implantitis

Treatments: Other: Probiotic - BioGaia; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02520401

s57668

Details and patient eligibility

About

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

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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22 participants in 2 patient groups, including a placebo group

Test

Experimental group

Description:

Probiotic tablet

Treatment:

Other: Probiotic - BioGaia

Control

Placebo Comparator group

Description:

Control tablet

Treatment:

Other: Placebo