Clinical Effects of Limosilactobacillus Reuteri Probiotics as an Adjunct to the Treatment of Periodontitis

November 27, 2023 updated by: André Marques, Universidade do Porto

Clinical Effects of Limosilactobacillus Reuteri Probiotics as an Adjunct to the Treatment of Periodontitis: A Randomized Controlled Trial

The purpose of this study is to evaluate the clinical efficacy of a probiotic lozenge containing Limosilactobacillus reuteri as an adjunct to the periodontal non-surgical treatment of patients with stage II, grade A, B and C, generalized periodontitis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The main purpose of this study is to assess the effect on disease progression of the probiotic Limosilactobacillus reuteri as an adjunct in the non-surgical periodontal treatment in patients with stage II, grade A, B and C, generalized periodontitis: evaluated by Bleeding on Probing (BoP) - Lindhe, 1972. The secondary purpose is to evaluate the effect of this probiotic on the values of Plaque Index (PI) - Silness & Löe, 1964; Gingival Index (GI) - Löe & Silness, 1963; Probing Pocket Depth (PPD), Clinical Attachment Level (CAL) - Ramfjord, 1959, when compared to a negative control product.

Study Type

Interventional

Enrollment (Estimated)

60

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 Contact

Study Locations

  • Portugal
      • Oporto, Portugal, 4200-393
        • Recruiting
        • Faculty of Dental Medicine - University of Porto
        • Contact:

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients over 18 years old, who intend to voluntarily participate in the study and:

    • Have a definitive diagnosis of stage II, grade A, B or C, generalized periodontitis (2018, World Workshop);
    • Have at least 3 natural teeth maintained per quadrant.

Exclusion Criteria:

  • • Patients unable to understand the instructions necessary to participate in the study or unable to give informed consent;

    • Patients who have received any type of periodontal treatment 2 months prior to the start of study participation;
    • Pregnant or breastfeeding patients;
    • Patients with associated systemic pathology, such as diabetes, HIV, asthma, hyperthyroidism, immune system pathologies, lichen erosive or other pathologies treated with corticosteroids or immunosuppressants;
    • Patients undergoing therapy with drugs that may interfere with the response of the gingival tissues: anti-inflammatory drugs, anticonvulsants (phenytoin and sodium valproate), immunosuppressants (cyclosporin-A and tacrolimus) and antihypertensives (nifedipine and verapamil hydrochloride);
    • Patients undergoing anticoagulant therapy;
    • Patients allergic to both lidocaine, articaine and mepivacaine;
    • Patients who require antibiotic prophylaxis for bacterial endocarditis;
    • Patients who have had antibiotic therapy within 2 months of study participation;
    • Patients using chlorhexidine, or other mouthwashes or elixirs;
    • Patients undergoing orthodontic treatment.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotics Lozenge
Subjects are instructed to take a lozenge twice a day, after brushing, in the morning and the evening.
Other: Probiotics
Probiotics lozenge containing at least 200 million active Limosilactobacillus reuteri.
Sham Comparator: Negative control Lozenge
Subjects are instructed to take a lozenge twice a day, after brushing, in the morning and the evening.
Other: Negative control
Sugar-free negative control lozenges.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Bleeding on Probing (BoP) - Lindhe, 1972
Time Frame: 0, 21, 90, 180 days
Bleeding on probing (in percentage) will be assessed 30 seconds after probing, through a dichotomous scoring system used at six sites per tooth using one (1) and zero (0) for presence or absence, respectively.
0, 21, 90, 180 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Plaque Index (PI) - Silness & Löe, 1964
Time Frame: 0, 21, 90, 180 days

Each of the four gingival areas of the tooth (mesialbuccal, buccal, distobuccal and palatinal/lingual) is given a score from 0-3; this is the Pl for the area (using plaque discloser. The scores from the four areas of the tooth may be added and divided by four to give the Pl for the tooth. Finally, by adding the indices for the teeth and dividing by the number of teeth examined, the Pl for the individual is obtained.

Scores criteria:

0 Absence of microbial plaque.

  1. Thin film of microbial plaque along the free gingival margin.
  2. Moderate accumulation with plaque in the sulcus.
  3. Large amount of plaque in sulcus or pocket along the free gingiva margin.
0, 21, 90, 180 days
Change From Baseline in Gingival Index (GI) - Löe e Silness, 1963
Time Frame: 0, 21, 90, 180 days

Four gingival areas of the tooth (mesialbuccal, buccal, distobuccal and palatinal/lingual) are given a score from 0 to 3; this is the Gl for the area. The scores from the four areas of the tooth may be added and divided by four to give the GI for the tooth. Finally, by adding the indices for the teeth and dividing by the total number of teeth examined, the Gl for the individual is obtained. The index for the subject is thus an average score for the areas examined.

Scores criteria:

0 Normal gingiva: Natural coral pink gingival with no e/o inflammation.

  1. Mild inflammation: Slight changes in color, slight edema. No bleeding on probing.
  2. Moderate inflammation: Redness, edema and glazing. Bleeding upon probing.
  3. Severe inflammation: Marked redness and edema/ulceration/tendency to bleed spontaneously.
0, 21, 90, 180 days
Change From Baseline in Probing Depth (PD)
Time Frame: 0, 21, 90, 180 days
The distance measured from the base of the sulcus or pocket to the free gingival margin.
0, 21, 90, 180 days
Change From Baseline in Clinical Attachment Level (CAL) - Ramfjord, 1959
Time Frame: 0, 21, 90, 180 days
It is calculated by adding the Probing Pocket Depth to the distance between the cementoenamel junction and the gingival margin (if it is a recession, the value is positive, if it is an increase in gingival volume the recorded value is negative).
0, 21, 90, 180 days

Collaborators and Investigators

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

Sponsor

Universidade do Porto

Collaborators

CREFAR - REPRESENTACÕES, LDA

Investigators

  • Principal Investigator: André Marques, MDent, Estudante da Especialização de Periodontologia e Implantologia

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)

February 1, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

January 25, 2023

First Submitted That Met QC Criteria

February 15, 2023

First Posted (Actual)

February 17, 2023

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31/2021

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.

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