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

Universidade do Porto

Status: Enrolling

Conditions: Chronic Periodontitis, Generalized

Treatments: Other: Negative control; Other: Probiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT05734274

31/2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Probiotics Lozenge

Experimental group

Description:

Subjects are instructed to take a lozenge twice a day, after brushing, in the morning and the evening.

Treatment:

Other: Probiotics

Negative control Lozenge

Sham Comparator group

Description:

Subjects are instructed to take a lozenge twice a day, after brushing, in the morning and the evening.

Treatment:

Other: Negative control