Clinical trial NCT05734274: Clinical Effects of Limosilactobacillus Reuteri Probiotics as an Adjunct to the Treatment of Periodontitis
Official title: Clinical Effects of Limosilactobacillus Reuteri Probiotics as an Adjunct to the Treatment of Periodontitis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Periodontitis, Generalized
Keywords: probiotics
Limosilactobacillus reuteri
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Bleeding on Probing (BoP) - Lindhe, 1972
timeFrame: 0, 21, 90, 180 days
Secondary outcomes:
measure: Change From Baseline in Plaque Index (PI) - Silness & Löe, 1964
timeFrame: 0, 21, 90, 180 days
measure: Change From Baseline in Gingival Index (GI) - Löe e Silness, 1963
timeFrame: 0, 21, 90, 180 days
measure: Change From Baseline in Probing Depth (PD)
timeFrame: 0, 21, 90, 180 days
measure: Change From Baseline in Clinical Attachment Level (CAL) - Ramfjord, 1959
timeFrame: 0, 21, 90, 180 days
Other outcomes:
Locations:
city: Oporto
country: Portugal
facility: Faculty of Dental Medicine - University of Porto
Study officials:
affiliation: Estudante da Especialização de Periodontologia e Implantologia
name: André Marques, MDent
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wei SH, Lang NP. Periodontal epidemiological indices for children and adolescents: II. Evaluation of oral hygiene; III. Clinical applications. Pediatr Dent. 1982 Mar;4(1):64-73. No abstract available.
citation: Montero E, Iniesta M, Rodrigo M, Marin MJ, Figuero E, Herrera D, Sanz M. Clinical and microbiological effects of the adjunctive use of probiotics in the treatment of gingivitis: A randomized controlled clinical trial. J Clin Periodontol. 2017 Jul;44(7):708-716. doi: 10.1111/jcpe.12752. Epub 2017 Jun 23.
citation: Iniesta M, Herrera D, Montero E, Zurbriggen M, Matos AR, Marin MJ, Sanchez-Beltran MC, Llama-Palacio A, Sanz M. Probiotic effects of orally administered Lactobacillus reuteri-containing tablets on the subgingival and salivary microbiota in patients with gingivitis. A randomized clinical trial. J Clin Periodontol. 2012 Aug;39(8):736-44. doi: 10.1111/j.1600-051X.2012.01914.x. Epub 2012 Jun 13.
citation: Vivekananda MR, Vandana KL, Bhat KG. Effect of the probiotic Lactobacilli reuteri (Prodentis) in the management of periodontal disease: a preliminary randomized clinical trial. J Oral Microbiol. 2010 Nov 2;2. doi: 10.3402/jom.v2i0.5344.
citation: Song D, Liu XR. Role of probiotics containing Lactobacillus reuteri in adjunct to scaling and root planing for management of patients with chronic periodontitis: a meta-analysis. Eur Rev Med Pharmacol Sci. 2020 Apr;24(8):4495-4505. doi: 10.26355/eurrev_202004_21032.
citation: Tekce M, Ince G, Gursoy H, Dirikan Ipci S, Cakar G, Kadir T, Yilmaz S. Clinical and microbiological effects of probiotic lozenges in the treatment of chronic periodontitis: a 1-year follow-up study. J Clin Periodontol. 2015 Apr;42(4):363-72. doi: 10.1111/jcpe.12387. Epub 2015 Apr 10.