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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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19 February 2015 |
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Main ID: |
NCT02194023 |
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Date of registration:
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13/07/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical Effects of Two New Chlorhexidine Digluconate Formulations: 0.12% and 0.03%.
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Scientific title:
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Inhibition of de Novo Plaque Formation and Side Effects of Two New Mouthrinse Formulations: 0.12% and 0.03% Chlorhexidine Digluconate, Respectively, in a 4-day Non-brushing Model. A Triple-blind, Randomized Clinical Trial. |
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Date of first enrolment:
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September 2011 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02194023 |
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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, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
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Phase:
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Phase 2
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Countries of recruitment
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Spain
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Contacts
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Name:
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Carolina Mor-Reinoso |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universitat Internacional de Catalunya |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 18-30 years
- Good overall health without medical history or medications that could interfere with
the study conduct.
- Minimum of 6 teeth per quadrant.
- Absence of probing depths =4mm.
Exclusion Criteria:
- Allergy to CHX or to CPC.
- Continuous use of CHX or of any other oral antiseptic in the months prior to the
study.
- Any adverse medical background or long-term medications that could affect gingival
conditions.
- Having taken antibiotics in the previous three months.
- Moderate to severe gingivitis (bleeding on probing = 40%). 41(Van der Weijden et al.
1994).
- Pregnancy or breastfeeding.
- Smokers of more than 5 cigarettes per day.
- Orthodontic appliances.
- Fixed or removable prostheses.
- Systemic diseases that increase the risk for gingival diseases (diabetes mellitus,
immunosuppression).
- Severe dental crowding.
Age minimum:
18 Years
Age maximum:
30 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Side Effects
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Dental Plaque
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Intervention(s)
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Drug: 0.12%NF
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Drug: Placebo: PCB
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Drug: PAT
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Drug: 0.03%NF
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Primary Outcome(s)
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Percentage of participants with greater reduction of plaque regrowth and side effects.
[Time Frame: Baseline to 4 days.]
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Secondary ID(s)
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PER-ECL-2011-06-NF
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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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