Effect of Probiotic Use Bifidobacterium Animalis Subsp. Lactis in Peri-implant Mucositis (Mucosite prob)

December 4, 2019 updated by: Michel Reis Messora, University of Sao Paulo

Clinical Effect of Probiotic Use Bifidobacterium Animalis Subsp. Lactis as Adjunctive Therapy in Non-surgical Treatment of Periimplant Mucositis: a Randomized Controlled Trial

Peri-implant disease is an inflammatory process of bacterial etiology that can affect the tissues around the implants and can be classified as peri-implant mucositis or peri-implantitis. The confirmation of the action of probiotics against microorganisms that cause peri-implant diseases can represent a great advance in the treatment of these diseases that affect a large part of the population, and may even reduce or prevent the use of antibiotics, reducing the risk of implant loss and, consequently, greater damage to the oral and systemic health of individuals. The purpose of this study was to evaluate the action of probiotics on the peri-implant health of total edentulous patients using Branemark protocol prosthetic rehabilitations. For this, 38 patients were selected, without systemic alterations and non-smokers. Clinical monitoring was performed at baseline (pre-intervention period) as well as at 12 and 24 weeks after study initiation. The following parameters were evaluated: modified gingival index (MGI), modified plaque index (MPI), probing depth (PD) and probing bleeding (PB). Data were subjected to statistical analysis at a significance level of 5%. There was an increase in sites with IGM 0 in the test group at 12 and 24 weeks. The test group presented more sites with IGM 0 than the control. IPM 0 sites increased in the control group at 12 and 24 weeks in the control group. PD decreases in a test and control group. Finally, the test group had lower PB rates. Thus, the probiotic used demonstrated ability to contribute to the improvement of peri-implant health of the patients analyzed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Clinical monitoring. MGI (0: no bleeding when a periodontal tube is passed along the mucosal margin adjacent to the implant; 1: visible isolated bleeding points; 2: blood forms a confluent red line at the mucosal margin and 3: profuse bleeding) and the MPI (0: no plaque; 1: plaque recognized only by probing through the smooth marginal surface of the implant; 2: plaque can be seen with the naked eye; 3: abundance of alba matter). PD was determined using a soft plastic periodontal probe for torque-controlled implants at 0.15 N / cm. Three buccal and three lingual reference points for each implant were used to calculate the mean probing depth in millimeters for each implant. PB was dichotomously evaluated: the presence of bleeding was considered positive when it occurred within 20 seconds after insertion of the probe to measure PD. The height of the keratinized mucosa present around each implant was also measured.

All clinical parameters described above were recorded at baseline (pre-intervention period) as well as at 12 and 24 weeks after study initiation.

Treatment of peri-implant mucositis and maintenance care. Prior to the beginning of the intervention, all patients received oral hygiene instruction. Mechanical debridements were performed with titanium curves and polishing using a rubber bowl and polishing paste. In the Test Group the treatment session was completed by a professional topical application around the carboxymethylcellulose gel implants containing 109 colony (CFU) forming units of B. lactis HN019. The gel was applied sub and supragingivally. The patients then received commercial capsules containing the same bacteria and were instructed to dissolve the capsule contents in 20 mL of water and rinse for 30 to 60 seconds, followed by swallowing twice a day for 12 weeks. The control group received the same oral hygiene instructions, mechanical debridement and was treated with gel and placebo tablets. At 3 months postoperatively, the same local mechanical and chemical treatment was repeated for the Test and Control groups.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 3

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

  • Brazil
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14040-904
        • School of Dentistry of Ribeirão Preto - University of Sao Paulo

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • completely edentulous lower or upper dental arch undergoing rehabilitation with dental implants;
  • prosthetic restoration in function for at least 6 months;
  • healthy individuals with no known systemic changes;
  • non smokers.

Exclusion Criteria:

  • patients who have received any type of local or systemic oral cavity decontamination treatment within the last 3 months or periodontal treatment within the last 6 months; uncontrolled periodontal disease;
  • patients with systemic disorders capable of influencing treatment outcomes;
  • smokers;
  • lack of informed consent to participate in the study;
  • presence of bone loss greater than 2 mm in dental implants.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Group
Mechanical treatment + Bifidobacterium animalis subsp. lactis
Other: Mechanical debridements
Prior to the beginning of the intervention, all patients received oral hygiene instruction. Mechanical debridements were performed with titanium curette and polishing using a rubber bowl and polishing paste.
Biological: Bifidobacterium animalis subsp. lactis
Capsules containing Bifidobacterium animalis subsp. lactis were chubby and subsequently ingested twice a day for 12 weeks.
Placebo Comparator: Control Group
Mechanical treatment + Placebo
Other: Mechanical debridements
Prior to the beginning of the intervention, all patients received oral hygiene instruction. Mechanical debridements were performed with titanium curette and polishing using a rubber bowl and polishing paste.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bleeding the probing.
Time Frame: Baseline.
Baseline.
Bleeding the probing.
Time Frame: 12 weeks.
12 weeks.
Bleeding the probing.
Time Frame: 24 weeks.
24 weeks.

Collaborators and Investigators

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

Sponsor

University of Sao Paulo

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 (Actual)

July 1, 2018

Primary Completion (Actual)

August 31, 2019

Study Completion (Actual)

November 15, 2019

Study Registration Dates

First Submitted

November 25, 2019

First Submitted That Met QC Criteria

December 4, 2019

First Posted (Actual)

December 5, 2019

Study Record Updates

Last Update Posted (Actual)

December 5, 2019

Last Update Submitted That Met QC Criteria

December 4, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 82840117.4.0000.5419

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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