Edentulous; Alveolar Process, Atrophy
Conditions
Brief summary
This is a non-inferiority study to evaluate whether L-PRF achieves similar or perhaps better results in bone gain, compared with the golden standard DBBM, after trans-crestal sinus floor elevation.
Detailed description
This is a randomized controlled clinical trial with parallel group design. A total of 40 patients, needing transcrestal sinus lift (T), will be enrolled. Under local anesthesia, the required T and implant placement will be performed and ISQ values will be recorded. Afterwards a CBCT will be taken for control. Randomization will be performed by computer generated random codes, using random permuted blocks with a block size of 4 to avoid uneven splits and minimization for the key prognostic factors RBH. Allocation will be concealed to the surgeons at completion of the common part of treatment, by opening an opaque envelope. At the same time an oral implant(s) will be inserted in the augmented area. After 6 months a CBCT will be taken for control of the bone healing and the measurements of the newly formed bone. The abutment will be placed on top of the osseo-integrated implant(s) under local anesthesia. ISQ values will be recorded. Follow-up will be till 1 year.
Interventions
Sponsors
Dentsply International
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volumetric bone regeneration en volumetric change | 6 and 12 months | Amount of bone formation in healing period after trans-crestal sinus floor elevation and implant placement and after healing, measured on CBCT images. Following a healing period of 6 and 12 months a CBCT will be taken to measure the height and width of the newly formed bone and compare it to the initial CBCT. A 3-D volumetric analysis of the amount of gained bone is conducted with MeVisLab software. |
| Linear bone regeneration en lineair change | 6 and 12 months | Amount of bone formation in healing period after trans-crestal sinus floor elevation and implant placement and after healing, measured on CBCT images. Following a healing period of 6 and 12 months a CBCT will be taken to measure the height and width of the newly formed bone and compare it to the initial CBCT. 2-D measurement will be performed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant stability based on resonance frequency | 6 months | Measurements of the implant stability via Osstell ISQ implant stability device. At implant placement and abutment connection a measurement via Osstell ISQ implant stability device will be done. |
Countries
Belgium
Outcome results
None listed