Limosilactobacillus Reuteri as an Adjuvant in the Treatment of Peri-implant Mucositis (LRRCT)

March 4, 2023 updated by: Malo Clinic

Limosilactobacillus Reuteri as an Adjuvant in the Treatment of Peri-implant Mucositis in Total Rehabilitation: an Exploratory Study

Mechanical debridement is the traditional method for the treatment of peri-implant mucositis and its success depends on the patient's correct oral hygiene. It is believed that probiotics may help by their ability to modulate the oral biofilm, resulting in anti-inflammatory and anti-bacterial plaque action. The aim of this study is to evaluate the adjuvant effect of the probiotic Limosilactobacillus reuteri in the mechanical treatment of peri-implant mucositis. This study aims to include 32 subjects with implant-supported total rehabilitation and peri-implant mucositis, divided into test and control groups, equally subjected to professional mechanical debridement, with the administration of a daily GUM® PerioBalance® lozenge for 30 days added to the test group. Plaque Index, Bleeding Index and probing pocket depth are evaluated before the intervention (baseline) and at 6 and 10 weeks later.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Lisbon, Portugal, 1600-042
        • Malo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

(i) dental implants placed for at least 12 months according to the All-on-4® concept;

(ii) removal of the dental prosthesis as part of the conventional implant maintenance protocol;

(iii) modified Bleeding Index19 score >0 in at least one implant in the studied rehabilitation;

(iv) implants connected to the prosthesis by means of transepithelial abutments;

(v) if there were natural teeth in opposing arch, they were periodontally healthy or had been treated for periodontitis and were on periodontal support with residual pockets ≤5mm;

(vi) demonstrated previous compliance with oral hygiene appointments; (vii) read and signed the informed consent.

Exclusion Criteria:

(i) Peri-implantitis proven clinically (implant mobility, suppuration and/or pocket depth (PD) ≥5mm) and/or radiographically (bone remodeling greater than 2mm in the first year of function20 and mean marginal bone loss greater than 0.2mm for each subsequent year21 in the rehabilitated arch that was intended to be studied);

(ii) clinically active peri-implantitis (mobility, suppuration and/or PD ≥5mm) in the opposing arch to the one intended to be studied;

(iii) presence of an extra-maxillary/zygomatic implant in the rehabilitated arch that was intended to be studied;

(iv) current probiotic supplementation;

(v) diabetes mellitus not controlled by medication;

(vi) current use of oral hygiene products containing chlorohexidine or essential oils;

(vii) special needs individuals who depended on others for their oral hygiene and medication uptake.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mechanical debridement + probiotic supplement
Patients with peri-implant mucositis treated through non-surgical professional mechanical debridement and probiotic supplement Limosilactobacillus reuteri Prodentis® (combining L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289 strains).
Dietary supplement: Limosilactobacillus reuteri Prodentis® (combining L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289 strains)
Non-surgical professional mechanical debridement and probiotic supplement Limosilactobacillus reuteri Prodentis® (combining L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289 strains)
No Intervention: Mechanical debridement
Patients with peri-implant mucositis treated through non-surgical professional mechanical debridement alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified bleeding index
Time Frame: baseline, 6 weeks, 10 weeks

Change of the bleeding score on each dental implant from baseline to 6 weeks and from baseline to10 weeks.

Modified bleeding index- 0: absence of bleeding; 1: isolated bleeding spots visible; 2: blood forms a confluent red line on margin; 3: heavy or profuse bleeding.
baseline, 6 weeks, 10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified plaque index
Time Frame: baseline, 6 weeks, 10 weeks

Change of the bacterial plaque score on each dental implant from baseline to 6 weeks and from baseline to10 weeks.

Modified plaque index- 0: absence of plaque; 1: plaque only visible after running the periodontal probe through the peri-implant sulcus around the implant; 2: plaque visible by the naked eye; 3: abundance of soft matter.
baseline, 6 weeks, 10 weeks
Probing pocket depth
Time Frame: baseline, 6 weeks, 10 weeks
Change of the probing pocket depth in milimeters on each dental implant from baseline to 6 weeks and from baseline to10 weeks. Values over 4 mm might indicate the presence of an acute or chronical peri-implant condition.
baseline, 6 weeks, 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Malo Clinic

Investigators

  • Principal Investigator: Gonçalo Parreira, MSc, Malo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2022

Primary Completion (Actual)

May 31, 2022

Study Completion (Actual)

September 18, 2022

Study Registration Dates

First Submitted

February 23, 2023

First Submitted That Met QC Criteria

March 4, 2023

First Posted (Estimate)

March 7, 2023

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 4, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LRRCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Upon reasonable request to the Principal Investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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