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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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26 October 2021 |
Main ID: |
NCT03496038 |
Date of registration:
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19/03/2018 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Transcrestal Lateral Sinus Floor Elevation in Implant Therapy
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Scientific title:
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Trans-crestal Sinus Floor Elevation in Implant Therapy: A Randomized Controlled Clinical Trail With Parallel Group Design: L-PRF Compared With DBBM |
Date of first enrolment:
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March 19, 2018 |
Target sample size:
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40 |
Recruitment status: |
Active, not recruiting |
URL:
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https://clinicaltrials.gov/show/NCT03496038 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Belgium
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Provision of informed consent
- Need for T and oral implant placement.
- RBH >3mm
Exclusion Criteria:
- Unlikely to be able to comply with the study procedures, as judged by the investigator
- Untreated periodontal disease
- Unfavorable plaque control
- Known or suspected current malignancy
- History of chemotherapy within 5y prior to study
- History of radiation on the head and neck region
- History of other metabolic bone diseases
- Need for systemic corticosteroids
- Current or previous use of intravenous/oral bisphosphonates
- Present alcohol and/or drug abuse
- Involvement in the planning and conduct of the study
- Psychiatric disorders which do not allow a normal treatment outcome
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Edentulous; Alveolar Process, Atrophy
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Intervention(s)
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Procedure: DBBM
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Procedure: L-PRF
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Primary Outcome(s)
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Volumetric bone regeneration en volumetric change
[Time Frame: 6 and 12 months]
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Linear bone regeneration en lineair change
[Time Frame: 6 and 12 months]
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Secondary Outcome(s)
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Implant stability based on resonance frequency
[Time Frame: 6 months]
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Secondary ID(s)
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Cortellini60096
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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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