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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: |
NCT02016001 |
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Date of registration:
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09/11/2013 |
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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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Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention
DMFT |
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Scientific title:
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Identification of Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention; A Randomized Controlled Trial |
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Date of first enrolment:
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April 2013 |
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Target sample size:
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380 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02016001 |
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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, Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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Pakistan
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Contacts
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Name:
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Dr. Aeeza Malik, BDS |
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Address:
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Telephone:
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0092-3126857665 |
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Email:
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draeezamalik@hotmail.com |
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Affiliation:
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Name:
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Dr. Ambrina Qureshi, BDS, M-Phil |
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Address:
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Telephone:
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Email:
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Affiliation:
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Head of Community Department, Dow University of Health Sciences, Karachi, Pakistan |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Regular school children of 12-15 years
2. Presence of at least four molars
Exclusion Criteria:
1. Non- consenting cases
2. Medically/physically compromised children
3. Children under any kind of parallel fluoride regime (systemic or topical)
4. Children consuming diet that is different from routine dietary practices
5. Children using toothpaste with greater than 1100 ppm and less than 500 ppm of
fluoride
6. Children found with rampant caries
7. Children found with all filled molars
8. Children with any oral infection abscess, periodontitis etc
9. Dentition with malocclusion
10. Children undergoing orthodontic/prosthodontic treatment
11. Children with Temporo mandibular joint disorder
12. Children who missed the baseline examinations
13. Loss to any follow-up cases
Age minimum:
12 Years
Age maximum:
15 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dental Caries
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Intervention(s)
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Other: toothpaste 1 with maximum fluoride concentration
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Other: toothpaste 2 with 1000 ppm of fluoride
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Primary Outcome(s)
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changes in DMFT (decayed, missing filled teeth) scores, over a period of 18 months.
[Time Frame: 18 months]
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Secondary ID(s)
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DUHS
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draeezamalik
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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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