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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: |
NCT00740311 |
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Date of registration:
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21/08/2008 |
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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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Filling of Tooth Sockets With MBCP Gel TM Versus Technical Without Filling
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Scientific title:
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Comparative Clinical Study of the Prevention of the Reduction of Alveolar Crest by Alveoli Filling With an Injectable Calcium Phosphate After Extraction of Mandibular Molar or Pre Molar |
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Date of first enrolment:
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November 2007 |
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Target sample size:
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00740311 |
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Study type:
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Interventional |
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Study design:
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N/A
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Yves Amouriq |
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Address:
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Telephone:
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Email:
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yves.amouriq@univ-nantes.fr |
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Affiliation:
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Name:
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Yves Amouriq |
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Address:
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Telephone:
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06 08 76 64 45 |
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Email:
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yves.amouriq@univ-nantes.fr |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Men and women, aged from 18 to 75 years, in good general health
- Affiliated to a national insurance scheme or a beneficiary such a regime, having had
a preliminary medical examination
- Without clinically significant buccal pathology or significant buccal concomitant
treatment
- Presenting at least a mandibular embedded premolar or molar not conservable (maximum
3 molars or premolars not conservable, and no akin tooth),
Exclusion Criteria:
- Emergency extraction, or extraction that should not entail an osseous resorption
other than a physiological one
- Lacteal tooth
- Trophic lesion
- Acute or chronic osteomyelitis, cellulitis, dry or infectious sachet non treated,
granuloma or cyst not treated
- Filling revised surgical site with non resorbable biomaterial waste
- Filling necrotic surgical site
- Opening of brains
- Past or planned cervicofacial irradiation
- Known addiction to tobacco and alcohol
- Patient that hasn't a sufficient oral hygiene and which could not be better
- Allergy to Spiramycine, Metronidazole, Hydroxyzine, Paracetamol, Dextropropoxyphene,
Chlorhexidine, or components of the local anesthesia
- Cancer, non equilibrate diabetes, tuberculosis, evolutionary or non equilibrate
infectious or inflammatory disease
- Degenerative osseous pathology
- Distance infection risk
- Immunodeficiency
- Corticoids or other treatment with an effect on phosphocalcic metabolism
- Expectant mothers, parturients and the mothers who nurse (efficient contraception is
mandatory).
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Alveolar Crest
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Intervention(s)
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Device: MBCP gel TM
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Primary Outcome(s)
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The primary outcome is to compare the reduction of the alveolar crest with or without alveoli filling, verifying if the height of the filled alveolar crests is higher after 3 or 6 month compared to the height of the unfilled alveolar crests.
[Time Frame: No]
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Secondary ID(s)
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BRD06/9-O
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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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