Clinical trial NCT03495700: Lateral Sinus Floor Elevation in Implant Therapy.
Official title: Lateral Sinus Floor Elevation in Implant Therapy: A Randomized Controlled Clinical Trail: L-PRF Block Compared With DBBM.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Edentulous; Alveolar Process, Atrophy
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Dentsply International
First posted: 2018-04-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is designed as a randomized controlled clinical trial.
Primary purpose: TREATMENT

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. The trial will comprise 8 visits. 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. A trephine bur of 3 mm in diameter will be use to obtain a biopsy of the test or control site. This will result in a biopsy sample of the healed site. At the exact same location of the biopsy the drilling will be performed according to implant protocol and the implant will be placed and ISQ values will be recorded. Follow-up will be till 1 year.

Eligibility criteria: 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

Primary outcomes:
measure: Volumetric bone regeneration
timeFrame: 6 months
measure: Linear bone regeneration
timeFrame: 6 months
Secondary outcomes:
measure: Implant stability based on resonance frequency
timeFrame: 4 months
measure: Histology: evaluation of bone biopsy at implant site
timeFrame: 6 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References: