NCT02520401

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 11, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 15, 2019

Status Verified

January 1, 2018

Enrollment Period

3.2 years

First QC Date

May 6, 2015

Last Update Submit

February 12, 2019

Conditions

Peri-implantitis

Outcome Measures

Primary Outcomes (1)

  • Probing Pocket Depth (PPD) at peri-implantitis sites

    Pocket probing depth measured with Merrit-B probe

    Baseline - 6 months

Secondary Outcomes (4)

  • Bleeding on Probing (BoP) at peri-implantitis sites

    Baseline - 6 months

  • Plaque at peri-implantitis sites

    Baseline - 6 months

  • Microbial samples

    Baseline - 6 months

  • Full mouth plaque score (FMPS)

    Baseline - 6 months

Study Arms (2)

Test

EXPERIMENTAL

Probiotic tablet

Other: Probiotic - BioGaia

Control

PLACEBO COMPARATOR

Control tablet

Other: Placebo

Interventions

Probiotic - BioGaiaOTHER

Use of a probiotic tablet

Test
PlaceboOTHER

Use of a placebo tablet

Control

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZLeuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2015

First Posted

August 11, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

February 15, 2019

Record last verified: 2018-01

Locations

BE(1)