Clinical Effects of Limosilactobacillus Reuteri Probiotics as an Adjunct to the Treatment of Periodontitis: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Universidade do Porto
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Bleeding on Probing (BoP) - Lindhe, 1972
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Probiotics Lozenge
Subjects are instructed to take a lozenge twice a day, after brushing, in the morning and the evening.
Intervention: Probiotics (Other)
Negative control Lozenge
Subjects are instructed to take a lozenge twice a day, after brushing, in the morning and the evening.
Intervention: Negative control (Other)
Outcomes
Primary Outcomes
Change From Baseline in Bleeding on Probing (BoP) - Lindhe, 1972
Time Frame: 0, 21, 90, 180 days
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.
Secondary Outcomes
- 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 Plaque Index (PI) - Silness & Löe, 1964(0, 21, 90, 180 days)
- Change From Baseline in Clinical Attachment Level (CAL) - Ramfjord, 1959(0, 21, 90, 180 days)
Investigators
André Marques
Principal investigator - student of the Specialization in Periodontology and Oral Implants
Universidade do Porto