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

Rambam Health Care Campus

Status: Active, not recruiting

Conditions: Missing Teeth; Bone Loss

Treatments: Device: Geistlich Bio-Oss® Granules; Device: Geistlich Bio-Oss® Collagen

Study type: Interventional

Funder types: Other

Identifiers

NCT04581304

0136-20-RMB CTIL

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

Bio-Oss Collagen

Experimental group

Description:

Transcrestal approach sinus augmentation using Geistlich Bio-Oss Collagen®.

Treatment:

Device: Geistlich Bio-Oss® Collagen

Bio-Oss Granules

Active Comparator group

Description:

Transcrestal approach sinus augmentation using Geistlich Bio-Oss®.

Treatment:

Device: Geistlich Bio-Oss® Granules