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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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26 October 2021 |
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Main ID: |
NCT03495700 |
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Date of registration:
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19/03/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Lateral Sinus Floor Elevation in Implant Therapy.
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Scientific title:
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Lateral Sinus Floor Elevation in Implant Therapy: A Randomized Controlled Clinical Trail: L-PRF Block Compared With DBBM. |
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Date of first enrolment:
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March 19, 2018 |
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Target sample size:
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24 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03495700 |
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Study type:
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Interventional |
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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 L and oral implant placement.
- RBH <4mm
- RBH >4mm, but no T possible (due to anatomy)
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 block
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Primary Outcome(s)
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Volumetric bone regeneration
[Time Frame: 6 months]
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Linear bone regeneration
[Time Frame: 6 months]
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Secondary Outcome(s)
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Histology: evaluation of bone biopsy at implant site
[Time Frame: 6 months]
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Implant stability based on resonance frequency
[Time Frame: 4 months]
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Secondary ID(s)
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Cortellini60095
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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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