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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT01211223 |
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Date of registration:
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28/09/2010 |
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Primary sponsor: |
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Public title:
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Effects of the Variation in the Time of Systemic Administration of Metronidazole and Amoxicillin Associated to the Non-surgical Therapy of Chronic Periodontitis.
Metro + Amoxi |
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Scientific title:
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Effects of the Variation in the Time of Systemic Administration of Metronidazole and Amoxicillin Associated to the Non-surgical Therapy of Chronic Periodontitis. |
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Date of first enrolment:
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January 2010 |
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Target sample size:
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36 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01211223 |
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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: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Chile
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Contacts
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Name:
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Jorge Gamonal, Professor |
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Address:
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Telephone:
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56-2-9721164 |
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Email:
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jgamonal@uchile.cl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- a) age of 35 years old or more, b) at least 3 molars in the mouth, c) at least one
site in three of the four quadrants with clinical attachment loss = 3mm; d) at least
4 sites in different teeth with probing depth and clinical attachment level = 6mm and
bleeding on probing and at least 14 tooth present in the mouth
Exclusion Criteria:
- a) previous professional root planning; b) systemic/topic antibiotic or
antiinflammatory treatment, at least 6 months prior to the initiation of the study;
c) inmunosupresion or need for antibiotic coverage for routine dental therapy; d)
systemic condition that could affect the progression of periodontal disease
(diabetes); e) pregnancy or lactation; e) allergy or intolerance to metronidazole or
amoxicillin; f) smokers
Age minimum:
35 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Periodontitis
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Clinical and Microbiological Effects
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Intervention(s)
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Drug: Administration of Metronidazole plus Amoxicillin
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Primary Outcome(s)
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- Mean change in clinical attachment level (CAL)
[Time Frame: 12 months]
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Secondary Outcome(s)
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- Mean change in probing pocket depths (PD)
[Time Frame: 12 months]
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Secondary ID(s)
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Facultad Odontologia, U Chile
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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