Periodontal Disease Clinical Trial
— AB-GUM-2016Official title:
Oral Colonization by Lactobacillus Brevis KABP 052 (CECT 7480) and Lactobacillus Plantarum KABP 051 (CECT 7481): A Randomized, Double-Blinded, Placebo-Controlled Trial
Verified date | December 2019 |
Source | AB Biotics, SA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Study will follow a randomized, double-blind, placebo-controlled design with two groups in parallel,N of 40 patients in 6 weeks of follow up for the evaluation of two different posology models (daily consumption of probiotic gum, with or without previous professional oral cleaning). Probiotics have recently been used to combat oral diseases (plaque control, caries, halitosis, etc.), as a non-invasive natural therapy.
Status | Completed |
Enrollment | 40 |
Est. completion date | February 27, 2017 |
Est. primary completion date | November 24, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Women and men between 18-55 years. - Capacity to understand the procedures and implications of the study. - Gingival Index <1,5 (Löe and Silness, Acta Odontol Scand. 1963. 21:533-51) - Plaque Index <2,0 (Löe and Silness, Acta Odontol Scand. 1963. 21:533-51) - Periodontal pocket depth <5 mm Exclusion Criteria: - Less than 20 natural teeth - More than 2 untreated caries at the time of enrollment - Current orthodontic or periodontal treatment - Hypersensitivity or allergy to any of the ingredients of the experimental product - Consumption of antibiotics in the 8 weeks prior to treatment - Use of probiotics designed to improve oral health, or having consumed them during the 8 weeks prior to the study - Consumption of any type of probiotic during the 4 weeks prior to the study - Usual consumption of clorhexidine or other mouthwashes with bactericidal active ingredients during the 30 days before the start of the study - Pregnant or lactating women - Participants with chronic diseases (eg, diabetes, kidney problems, cancer) or under chronic treatment |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
AB Biotics, SA | Clínica Odontológica Nart en Barcelona |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Probiotic colonization of the oral cavity (qPCR) | Quantification of L. brevis and L. plantarum by species-specific qPCR in pooled samples of saliva, dental plaque (from the CPI subset) and lingual plaque | Change from Baseline assessed 6 weeks after study entry | |
Secondary | Progression of PII | Plaque Index (PlI; Silness and Löe 1964) in the CPI teeth subset, as recorded at the first visit and at the end of the study by the dentist. | Change from Baseline assessed 6 weeks after study entry | |
Secondary | Progression of GI | Gingival Index (GI; Löe and Silness 1963) in the CPI teeth subset, as recorded at the first visit and at the end of the study by the dentist. | Change from Baseline assessed 6 weeks after study entry |
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