The Use of Bio-Oss Collagen for Sinus Augmentation Using the Transcrestal Approach.

Last updated: April 2, 2023
Sponsor: Rambam Health Care Campus
Overall Status: Active - Recruiting

Phase

N/A

Condition

Periodontitis

Osteoporosis

Osteopenia

Treatment

N/A

Clinical Study ID

NCT04581304
0136-20-RMB CTIL
  • Ages 18-100
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

To assess vertical bone height gain with Geistlich Bio-Oss Collagen used in conjunction with simultaneous implant installation in transcrestal approach sinus augmentation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients above the age of 18.
  • Patients with edentulous ridge maximal height of 8mm≥ beneath the maxillary sinus.
  • Patients with edentulous ridge minimal height of 3mm≤ beneath the maxillary sinus.
  • Patients who need single implant placement at the posterior maxilla.
  • Signed, well filled and dated informed consent form.

Exclusion

Exclusion Criteria:

  • Inability to complete or understand the informed consent process.
  • Pregnant women.
  • Lactating women.
  • Patients who use medications that affect bone metabolism such as IV bisphosphonates.
  • Heavy smokers.
  • Patients with chronic/acute sinus infections

Study Design

Total Participants: 30
Study Start date:
October 15, 2020
Estimated Completion Date:
February 16, 2024

Study Description

One of the most common situations in the posterior maxilla is reduced alveolar bone height as a result of tooth extraction and the following bone remodeling process, and maxillary sinus pneumatization. Lack of alveolar bone volume may compromise dental implant installation. Maxillary sinus augmentation is considered a very predictable solution for implant installation in limited amount of bone in the posterior maxilla. In general, there are two main maxillary sinus augmentation methods: the lateral approach and the transcrestal. In both methods, the idea is to expend the alveolar ridge in vertical direction on the expense of the maxillary sinus. Sinus augmentation using the transcrestal approach is a well known procedure which is being use for over 40 years. As time goes by, implant dentistry is evolving and improving, there is a constant progress in this field including new bone substitutes materials.

Geistlich Bio-Oss® Collagen - can improve the results obtained by sinus augmentation using the transcrestal approach, by better ease of use for the operator which makes it easier for the operator and the patient.

Study hypothesis: The vertical bone height gained by using Geistlich Bio-Oss Collagen in transcrestal approach sinus augmentation will be comparable to using Bio-Oss Collagen, with greater operator satisfaction and less intra-operative complications.

Connect with a study center

  • Rambam Health Care Campus, Dept. of Periodontology

    Haifa, 31096
    Israel

    Active - Recruiting

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