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Transcrestal Lateral Sinus Floor Elevation in Implant Therapy

NCT ID: NCT03496038

Last Updated: 2021-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-19

Study Completion Date

2022-06-30

Brief Summary

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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

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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.

Conditions

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Edentulous; Alveolar Process, Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Leukocyte and Platelet Rich Fibrin (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).

Group Type EXPERIMENTAL

L-PRF

Intervention Type PROCEDURE

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

Deproteinized Bovine Bone Mineral (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).

Group Type ACTIVE_COMPARATOR

DBBM

Intervention Type PROCEDURE

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

Interventions

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L-PRF

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

Intervention Type PROCEDURE

DBBM

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dentsply International

INDUSTRY

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Drs. Simone Cortellini

Clinical and Research Associate

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UZ Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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Cortellini60096

Identifier Type: -

Identifier Source: org_study_id