Transcrestal Lateral Sinus Floor Elevation in Implant Therapy

NCT03496038 | Unknown DMC

• 1 other identifier: Cortellini60096
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Edentulous; Alveolar Process, Atrophy

Outcome Measures

Primary Outcomes (2)

• Volumetric bone regeneration en volumetric change

  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.

  6 and 12 months

• Linear bone regeneration en lineair change

  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.

  6 and 12 months

Secondary Outcomes (1)

• Implant stability based on resonance frequency

  6 months

Study Arms (2)

Leukocyte and Platelet Rich Fibrin (L-PRF)

EXPERIMENTAL

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).

Procedure: L-PRF

Deproteinized Bovine Bone Mineral (DBBM)

ACTIVE COMPARATOR

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).

Procedure: DBBM

Interventions

L-PRF PROCEDURE

The use of the L-PRF as graft material for sinus augmentation procedure will be analysed

Leukocyte and Platelet Rich Fibrin (L-PRF)

DBBM PROCEDURE

The use of bovine xenograft as graft material for sinus augmentation procedure will be analysed

Deproteinized Bovine Bone Mineral (DBBM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent
• Need for T and oral implant placement.
• RBH \>3mm

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Dentsply International: collaborator

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Mouth, Edentulous; Atrophy

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical and Research Associate

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: April 12, 2018
• Study Start: March 19, 2018
• Primary Completion: January 1, 2022
• Study Completion: June 1, 2022
• Last Updated: October 15, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)