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

NCT05734274 | Unknown

• 1 other identifier: 31/2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis, Generalized

Keywords

probiotics; Limosilactobacillus reuteri

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Bleeding on Probing (BoP) - Lindhe, 1972

  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 Outcomes (4)

• Change From Baseline in Plaque Index (PI) - Silness & Löe, 1964

  0, 21, 90, 180 days

• Change From Baseline in Gingival Index (GI) - Löe e Silness, 1963

  0, 21, 90, 180 days

• Change From Baseline in Probing Depth (PD)

  0, 21, 90, 180 days

• Change From Baseline in Clinical Attachment Level (CAL) - Ramfjord, 1959

  0, 21, 90, 180 days

Study Arms (2)

Probiotics Lozenge

EXPERIMENTAL

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

Other: Probiotics

Negative control Lozenge

SHAM COMPARATOR

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

Other: Negative control

Interventions

Probiotics OTHER

Probiotics lozenge containing at least 200 million active Limosilactobacillus reuteri.

Probiotics Lozenge

Negative control OTHER

Sugar-free negative control lozenges.

Negative control Lozenge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade do Porto: lead

Study Sites (1)

Faculty of Dental Medicine - University of Porto

Porto, 4200-393, Portugal

RECRUITING

Related Publications (6)

• 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.

  PMID: 6960328 BACKGROUND

• 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.

  PMID: 28556062 BACKGROUND

• 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.

  PMID: 22694350 BACKGROUND

• 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.

  PMID: 21523225 BACKGROUND

• 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.

  PMID: 32373987 BACKGROUND

• 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.

  PMID: 25728888 BACKGROUND

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• André Marques, MDent

  Estudante da Especialização de Periodontologia e Implantologia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

André Marques, MDent

CONTACT

+351965074955; andrecnbmarques@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator - student of the Specialization in Periodontology and Oral Implants

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 17, 2023
• Study Start: February 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: July 1, 2024
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)