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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02490618 |
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Date of registration:
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06/05/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Use of a Probiotic Lozenge in the Treatment of Residual Pockets After Classical Non-surgical Therapy
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Scientific title:
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The Use of a Probiotic Lozenge in the Treatment of Residual Pockets After Classical Non-surgical Therapy |
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Date of first enrolment:
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January 2016 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02490618 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Belgium
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 40 patients
- = 18 years of age
- scaling and rootplaning received at least 3 months ago
- Patients diagnosed with residual pockets (at least 2), with the definition of residual
pockets:> 5mm or 5 and BOP+
- Willing and able to give written informed consent
Exclusion Criteria:
- patients with aggressive periodontitis
- patients who smoke
- pregnant or lactating woman
- patients with poorly controlled diabetes
- patients taking bisphosphonate mediation
- patient who had taken systemic antibiotics 3 months prior to treatment
Age minimum:
18 Years
Age maximum:
99 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Periodontitis
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Intervention(s)
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Other: Probiotic tablet- Biogaia
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Other: Placebo tablet
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Primary Outcome(s)
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Clinical Attachment Loss (CAL) at teeth with residual pockets
[Time Frame: 3-6 months]
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Recessions (REC) at teeth with residual pockets
[Time Frame: 3-6 months]
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Pocket Probing Depth (PPD) at teeth with residual pockets
[Time Frame: 3-6 months]
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Secondary Outcome(s)
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Overall PPD, REC, CAL
[Time Frame: 3-6 months]
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Full Mouth Plaque Score (FMPS) and Full Mouth Bleeding Score (FMBS)
[Time Frame: 3-6 months]
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Bleeding on Probing (BoP) at teeth with residual pockets
[Time Frame: 3-6 months]
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Microbial samples: deepest pocket, saliva, tongue
[Time Frame: 3-6 months]
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Plaque at teeth with residual pockets
[Time Frame: 3-6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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