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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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13 June 2016 |
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Main ID: |
NCT02789436 |
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Date of registration:
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04/04/2016 |
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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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Effect of Probiotic Lozenges on Halitosis in Patients With Chronic Periodontitis
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Scientific title:
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Effect of Probiotic Lactobacillus Reuteri-containing Lozenges (Prodentis) on Halitosis in Patients With Chronic Periodontitis |
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Date of first enrolment:
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June 2016 |
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Target sample size:
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30 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02789436 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
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Phase:
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Phase 4
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Countries of recruitment
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Croatia
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Contacts
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Name:
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Larisa Music, DMD |
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Address:
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Telephone:
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Email:
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lmusic@sfzg.hr |
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Affiliation:
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Name:
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Larisa Music, DMD |
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Address:
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Telephone:
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Email:
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lmusic@sfzg.hr |
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Affiliation:
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Name:
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Darije Plancak, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Zagreb, School of Dental Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult patients, above age of 30
- Non-smokers or ex-smokers (not smoking in the past year)
- Moderate to advanced untreated chronic periodontitis
- Good compliance and following of oral hygiene instructions
- Halitosis in active phase and patient's subjective complaint
- Informed consent by the patient
Exclusion Criteria
- Aggressive periodontitis
- Antibiotics administered up to 3 months prior to this study
- Pregnancy and breastfeeding
- Immunosuppressive therapy
- Oral neoplasms (including radiation or chemotherapy)
- Diabetes mellitus
- Acute oral inflammation or infection
- Poor, unsatisfactory oral hygiene and lack of compliance
- Use of dietary supplements containing probiotics within 2 weeks prior to study start
Age minimum:
30 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Halitosis
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Intervention(s)
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Drug: L. reuteri Prodentis® lozenges
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Other: Placebo lozenges
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Primary Outcome(s)
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Change in VSC concentration in mouth air
[Time Frame: 28 days]
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Secondary Outcome(s)
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Change from Baseline in Bleeding on Probing (BOP)
[Time Frame: 28 days]
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Changes in halitosis associated quality of life
[Time Frame: 28 days]
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Change from Baseline in Plaque Accumulation (PCR)
[Time Frame: 28 days]
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Secondary ID(s)
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05-PA-26-10/15
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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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