Clinical Effects of Limosilactobacillus Reuteri Probiotics as an Adjunct to the Treatment of Periodontitis
NCT ID: NCT05734274
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-02-01
2024-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Probiotics Lozenge
Subjects are instructed to take a lozenge twice a day, after brushing, in the morning and the evening.
Probiotics
Probiotics lozenge containing at least 200 million active Limosilactobacillus reuteri.
Negative control Lozenge
Subjects are instructed to take a lozenge twice a day, after brushing, in the morning and the evening.
Negative control
Sugar-free negative control lozenges.
Interventions
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Probiotics
Probiotics lozenge containing at least 200 million active Limosilactobacillus reuteri.
Negative control
Sugar-free negative control lozenges.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Universidade do Porto
OTHER
Responsible Party
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André Marques
Principal investigator - student of the Specialization in Periodontology and Oral Implants
Principal Investigators
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André Marques, MDent
Role: PRINCIPAL_INVESTIGATOR
Estudante da Especialização de Periodontologia e Implantologia
Locations
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Faculty of Dental Medicine - University of Porto
Porto, , Portugal
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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31/2021
Identifier Type: -
Identifier Source: org_study_id