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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Effects of Limosilactobacillus Reuteri Probiotics as an Adjunct to the Treatment of Periodontitis: A Randomized Controlled Trial

Conditions
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Chronic Periodontitis, Generalized

Intervention / Treatment
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* Other: Probiotics
* Other: Negative control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics Lozenge<br>Subjects are instructed to take a lozenge twice a day, after brushing, in the morning and the evening. | Other: Probiotics<br>* Probiotics lozenge containing at least 200 million active Limosilactobacillus reuteri.<br>|
| Sham Comparator: Negative control Lozenge<br>Subjects are instructed to take a lozenge twice a day, after brushing, in the morning and the evening. | Other: Negative control<br>* Sugar-free negative control lozenges.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Plaque Index (PI) - Silness & Löe, 1964 | Each of the four gingival areas of the tooth (mesialbuccal, buccal, distobuccal and palatinal/lingual) is given a score from 0-3; this is the Pl for the area (using plaque discloser. The scores from the four areas of the tooth may be added and divided by four to give the Pl for the tooth. Finally, by adding the indices for the teeth and dividing by the number of teeth examined, the Pl for the individual is obtained. Scores criteria: 0 Absence of microbial plaque. Thin film of microbial plaque along the free gingival margin. Moderate accumulation with plaque in the sulcus. Large amount of plaque in sulcus or pocket along the free gingiva margin. | 0, 21, 90, 180 days | 
| Change From Baseline in Gingival Index (GI) - Löe e Silness, 1963 | Four gingival areas of the tooth (mesialbuccal, buccal, distobuccal and palatinal/lingual) are given a score from 0 to 3; this is the Gl for the area. The scores from the four areas of the tooth may be added and divided by four to give the GI for the tooth. Finally, by adding the indices for the teeth and dividing by the total number of teeth examined, the Gl for the individual is obtained. The index for the subject is thus an average score for the areas examined. Scores criteria: 0 Normal gingiva: Natural coral pink gingival with no e/o inflammation. Mild inflammation: Slight changes in color, slight edema. No bleeding on probing. Moderate inflammation: Redness, edema and glazing. Bleeding upon probing. Severe inflammation: Marked redness and edema/ulceration/tendency to bleed spontaneously. | 0, 21, 90, 180 days | 
| Change From Baseline in Probing Depth (PD) | The distance measured from the base of the sulcus or pocket to the free gingival margin. | 0, 21, 90, 180 days | 
| Change From Baseline in Clinical Attachment Level (CAL) - Ramfjord, 1959 | It is calculated by adding the Probing Pocket Depth to the distance between the cementoenamel junction and the gingival margin (if it is a recession, the value is positive, if it is an increase in gingival volume the recorded value is negative). | 0, 21, 90, 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotics, Limosilactobacillus reuteri