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

Recruiting
18 years of age
Both
Phase N/A

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Overview

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.

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.

Eligibility

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 details

Chronic Periodontitis, Generalized

NCT05734274

Universidade do Porto

26 January 2024

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