Effect of Probiotic Lactobacillus Reuteri in the Treatment of Mucositis and Periimplantitis

March 27, 2020 updated by: MARTA GALOFRÉ MERCADÉ, Universitat Internacional de Catalunya

Clinical and Microbiological Evaluation of the Effect of Probiotic Lactobacillus Reuteri Prodentis in the Treatment of Mucositis and Periimplantitis

Evaluate clinically and microbiologically the effect of the oral probiotic Lactobacillus reuteri Prodentis (PerioBalance®, Sunstar, Switzerland) on implants with mucositis or periimplantitis, as a coadjuvant treatment of mechanical therapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A total of 44 patients, 22 with mucositis and 22 with periimplantitis, were randomly assigned to either the control or the test group, so that 11 patients received placebo and 11 probiotic treatment. After the baseline clinical, radiological and microbiological examination, and once the study group was randomly assigned (probiotic or placebo), supragingival prophylaxis was performed in the mucositis group and subgingival mechanical therapy in the periimplantitis group. Then they get a container with 30 probiotic or placebo tablets and instructions on how and when to take them. At 30 and 90 days after beginning the treatment, a clinical, radiological and microbiological examination was performed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients with general good health,
  • non-smokers,
  • history of mild or moderate chronic periodontitis
  • at least one dental implant with probing pocket depth ≥4mm together with bleeding on probing and/or suppuration, and a fixed prosthetic restoration in function for at least 12 months,
  • compliance with the periodontal maintenance program,
  • accessibility during all the study period and receptiveness and ability to fulfill with the protocol.

Exclusion Criteria:

  • pregnant or lactating women,
  • patients who required prophylaxis of bacterial endocarditis or had taken local or systemic antibiotic, anti-inflammatory, antiseptic or probiotic therapy in the previous 3 months,
  • subjects who had received surgical periodontal treatment in the last 6 months,
  • uncontrolled periodontal disease,
  • previous or current history of alcoholism or smoking,
  • treatment with bisphosphonates, neurologic deficiencies, systemic diseases such as immunodeficiencies or uncontrolled diabetes, rheumatoid, hepatic, renal, cardiovascular or infectious pathologies, radiotherapy, chemotherapy, use of any medication which can affect at periodontal level,
  • lack of patient cooperation (failure to follow the treatment instructions and/or failure to attend visits),
  • implants with mobility and/or radiographic bone loss ≥ 5mm and/or ≥ 50% of implant length.

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: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Control group: placebo oral tablet
Placebo tablets. Intervention: 30 placebo tablets were given after the mechanical debridement of implants with mucositis and periimplantitis.
Device: Placebo Oral Tablet
30 placebo tablets were given after the mechanical debridement of implants with mucositis and periimplantitis.
Experimental: Test group: probiotic oral tablet
Probiotic tablets (Periobalance®, Sunstar, Switzerland). Intervention: 30 probiotic tablets were given after the mechanical debridement of implants with mucositis and periimplantitis.
Drug: Probiotic
30 probiotic tablets were given after the mechanical debridement of implants with mucositis and periimplantitis.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Probing pocket depth
Time Frame: Differences between baseline and 30 and 90 days will be calculated.
The probing pocket depth was recorded, in millimeters and at six points per tooth and implant, as the distance from the gingival margin to the bottom of the periodontal pocket and peri-implant mucosa. Measurements will be performed by a masked and calibrated investigator.
Differences between baseline and 30 and 90 days will be calculated.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plaque index
Time Frame: Differences between baseline and 30 and 90 days will be calculated.
The general plaque index (PI) was recorded according to O'Leary et al., dichotomously assigning the presence or absence of plaque on four surfaces per tooth and implant. The implant plaque index (IPI) was recorded by assigning a dichotomous value to the presence or absence of plaque (1 indicating presence of plaque and 0 absence of plaque) of the implant under study. Measurements will be performed by a masked and calibrated investigator.
Differences between baseline and 30 and 90 days will be calculated.
Bleeding on probing
Time Frame: Differences between baseline and 30 and 90 days will be calculated.
The general bleeding on probing (BOP) was determined according to Ainamo and Bay, evaluating dichotomously the presence or absence of bleeding on the mesial, distal, buccal and lingual/palatal dental or implant surfaces. The implant bleeding on probing (BOPI) was recorded using a dichotomous value depending on whether the implant under study presented bleeding or not (1 indicated bleeding and 0 no bleeding). Measurements will be performed by a masked and calibrated investigator.
Differences between baseline and 30 and 90 days will be calculated.
Microbiological tests
Time Frame: Differences between baseline and 30 and 90 days will be calculated.
Microbiological tests were performed in the deepest periimplant pocket, using the Guidor Perio-Implant Diagnostic Test® (Sunstar S.A, Switzerland), which by means of Real-Time PCR identified and quantified the total bacterial load of A. actinomycetemcomitans (DSM 8324), T. forsythia (CIP 105220), P. gingivalis (DSM 20709), T. denticola (DSM 14222), P. intermedia (DSM 20706), P. micros (DSM 20468), F. nucleatum (DSM 20482), C. rectus (LMG 18530) and E. corrodens (DSM 8340). Measurements will be performed by a masked and calibrated investigator.
Differences between baseline and 30 and 90 days will be calculated.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitat Internacional de Catalunya

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marta Galofré Mercadé, Universitat Internacional de Catalunya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Universitat Internacional

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

Clinical Trials on Mucositis

Clinical Trials on Placebo Oral Tablet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings