Transcrestal Lateral Sinus Floor Elevation in Implant Therapy

Not Applicable

• Conditions: Edentulous; Alveolar Process, Atrophy
• Interventions: Procedure: DBBM; Procedure: L-PRF

• Registration Number: NCT03496038
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Study Start: 2018-03-19
• Study First Submitted: 2018-03-19
• Study First Submitted QC: 2018-04-04
• Study First Posted: 2018-04-12
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-14
• Last Update Posted: 2021-10-15
• Primary Completion: 2022-01
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deproteinized Bovine Bone Mineral (DBBM)	DBBM	For the test group the sub-sinus cavity will be filled with deproteinized bovine bone mineral (DBBM). The product used will be a xenograft (Bio-Oss Small particles, Geistlich AG, Wolhusen, Switzerland).
Leukocyte and Platelet Rich Fibrin (L-PRF)	L-PRF	For the test group the sub-sinus cavity will be filled with Leukocyte en Platelet Rich Fibrin (L-PRF). Before starting the surgery, 8 tubes (9 ml) of venous blood will be collected from the patients. A centrifugation standard L-PRF protocol will be followed followed (12 minutes centrifugation, 2700 rpm/408g RCF). After full centrifugation of the tubes, the L-PRF clots will be removed from the tubes using surgical tweezers. The clots will be thereafter gently compressed into membranes using a sterile metal box (Xpression, Intra-Lock, Florida, USA).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium