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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics Lozenge | Experimental | Subjects are instructed to take a lozenge twice a day, after brushing, in the morning and the evening. |
|
| Negative control Lozenge | Sham Comparator | Subjects are instructed to take a lozenge twice a day, after brushing, in the morning and the evening. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics | Other | Probiotics lozenge containing at least 200 million active Limosilactobacillus reuteri. |
|
| 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 |
| 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.
|
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Inclusion Criteria:
Patients over 18 years old, who intend to voluntarily participate in the study and:
Exclusion Criteria:
• Patients unable to understand the instructions necessary to participate in the study or unable to give informed consent;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| André Marques, MDent | Contact | +351965074955 | andrecnbmarques@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| André Marques, MDent | Estudante da Especialização de Periodontologia e Implantologia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dental Medicine - University of Porto | Recruiting | Porto | 4200-393 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6960328 | Background | 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. | |
| 28556062 | 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. |
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| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Negative control | Other | Sugar-free negative control lozenges. |
|
| 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.
| 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 |
| 22694350 | 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. |
| 21523225 | 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. |
| 32373987 | 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. |
| 25728888 | 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. |
| D002908 |
| Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019602 |
| Food and Beverages |