The Use of a Probiotic Lozenge in the Treatment of Peri-i... | NCT02520401

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

NCT02520401

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Last Update Posted

Feb 15, 2019Actual

Enrollment

22Actual

Phase

Not Applicable

Conditions

Peri-implantitis

Interventions

Probiotic - BioGaia
Placebo

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Dec 2018Actual

Completion Date

Dec 2018Actual

First Submitted Date

May 6, 2015

First Submission Date that Met QC Criteria

Aug 6, 2015

First Posted Date

Aug 11, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2019

Last Update Posted Date

Feb 15, 2019Actual

Name	Class
BioGaia AB	INDUSTRY

Description Module

Brief Summary

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

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test	Experimental	Probiotic tablet	Other: Probiotic - BioGaia
Control	Placebo Comparator	Control tablet	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Probiotic - BioGaia	Other	Use of a probiotic tablet	Test
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Probing Pocket Depth (PPD) at peri-implantitis sites	Pocket probing depth measured with Merrit-B probe	Baseline - 6 months

Secondary Outcomes

Measure	Description	Time Frame
Bleeding on Probing (BoP) at peri-implantitis sites	Binairy outcome: 0: no bleeding, 1: bleeding	Baseline - 6 months
Plaque at peri-implantitis sites	Binairy outcome: 0: no plaque, 1: plaque

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
UZLeuven		Leuven		3000	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D057873	Peri-Implantitis

Ancestor Terms

ID	Term
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided