Edentulous; Alveolar Process, Atrophy
Conditions
Brief summary
The L-PRF block is a combination of bone substitute with L-PRF. The use of a L-PRF block in bone augmentation therapies could enhance and improve bone regeneration. The primary objective of this study is to evaluate if the use of autologous leukocytes and platelet rich fibrin accelerate and promotes bone regeneration in the sinus in comparison with the standard sinus lift procedure procedure.
Detailed description
This is a randomized controlled clinical trial. A total of 24 patients, needing sinus lift with lateral window technique (L), will be enrolled. All patients have to fulfil all of the inclusion and none of the exclusion criteria. Written informed consent will be obtained prior to any examination carried out for study purposes. Randomization will be performed using sealed, sequentially numbered, opaque envelopes containing treatment allocation. Under local anaesthesia, the required L will be performed. Once the blood extraction is done the surgery can start following the normal procedure for the lateral approach of sinus floor elevation. Once the preparation of the sinus floor elevation is done the randomization envelopes will be open and the selected treatment will be applied. For the test group the sub-sinus cavity will be filled with L-PRF block and the window will be closed with L-PRF membranes. For the control group the sub-sinus cavity will be filled with only DBBM and the window will be closed with a collagen membrane. Afterwards suturing will be conducted and a CBCT will be taken for control and observation. After 6 months the subjects return for a check-up of the healing process. A CBCT will be taken to assess the bone regeneration. Implant surgery will be discussed. With a crestal incision the implant site will be exposed. The drilling will be performed according to implant protocol and the implant will be placed. Follow-up will be till 5 year.
Interventions
PROCEDUREL-PRF block
The use of the L-PRF block as graft material for sinus augmentation procedure will be analysed
PROCEDUREDBBM
The use of bovine xenograft will be analysed
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
This study is designed as a randomized controlled clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Males and females ≥ 18 years of age. * Ability to understand the nature of the proposed surgical procedure and sign an informed consent form. * ASA I and ASA II. * In need of an implant in the posterior region of the maxilla, * RBH of \<4 mm or RBH \>4 mm but no transcrestal approach possible (due to anatomy). * Healthy oral mucosa and no active periodontal disease. * Edentulous sites consisting of native, non-augmented bone.
Exclusion criteria
* General contraindications for implant placement and/or surgical treatment. * Acute infection or residual lesions in the edentulous sites. * Acute maxillary sinus pathosis. * Ongoing inflammatory and/or autoimmune diseases of the oral cavity. * Patients with poor oral hygiene who are not amenable to improvement. * Immunosuppressants, corticosteroids, or bisphosphonate * History of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years. * Smoker \> 10 cigarettes. * Uncontrolled insulin-dependent diabetes. * Pregnant or lactating women. * Alcohol and drug abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volumetric bone regeneration | 6 months | Amount of bone formation after lateral sinus floor elevation scored at implant placement, measured on CBCT images. Following a healing period of 6 months a CBCT will be taken to evaluate 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant survival | 5 years | The implants inserted after sinus grafting procedures would be followed for up to 5 years. Marginal bone loss would be examined using intraoral long-cone radiographs |
| Linear bone regeneration | 6 months | Amount of bone formation after lateral sinus floor elevation scored at implant placement, measured on CBCT images. Following a healing period of 6 months a CBCT will be taken to evaluate the height and width of the newly formed bone and compare it to the initial CBCT. 2-D measurements will be performed. |
Countries
Belgium
Outcome results
None listed