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Microarchitecture of the Augmented Bone Following Sinus Elevation

NCT04136509 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-06-02

No results posted yet for this study

Summary

In this prospective randomized clinical study sinus floor elevation procedures are preformed using different biomaterials with the lateral window technique. After a 6-month healing, at the time of dental implant placement bone core biopsy samples are harvested. The samples undergo micro-Ct and histomorphometric analysis.

Conditions

  • Alveolar Bone Loss
  • Sinus Pneumatization
  • Edentulous; Alveolar Process, Atrophy

Interventions

PROCEDURE

sinus floor elevation

sinus floor elevation with the lateral technique

PROCEDURE

bone core biopsy

After 6 month healing time reentry took place and bone core biopsy samples were collected from the augmented bone of the maxillary sinuses with a trephine drill. Biopsy samples were collected from the sites where the dental implants were to be placed.

DEVICE

dental implant placement

During reentry after bone biopsy dental implants were placed.

DIAGNOSTIC_TEST

Cone Beam Computed Tomography scans (CBCT)

Preoperative CBCT scans are carried out before dental implant placement, 6 months after sinus floor elevations. Postoperative CBCT scans are taken 3 years after sinus floor augmentations.

Sponsors & Collaborators

  • Semmelweis University

    lead OTHER

Principal Investigators

  • György Szabó, Md PhD Msc · Department of Oro-Maxillofacial Surgery and Stomatology Semmelweis University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-01
Primary Completion
2016-12-31
Completion
2021-09-01

Countries

  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04136509 on ClinicalTrials.gov