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

Bone Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04581304
• Other study ID #: 0136-20-RMB CTIL
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2020
• Est. completion date: February 16, 2024

Study information

• Verified date: April 2023
• Source: Rambam Health Care Campus
• Contact: Prof Hadar Zigdon, DMD
• Phone: 9727772983
• Email: h_zigdon[@]rambam.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 16, 2024
• Est. primary completion date: September 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Anodontia
• Bone Loss
• Missing Teeth
• Tooth Loss

Intervention

Device:
• Geistlich Bio-Oss® Collagen
Geistlich Bio-Oss® Collagen is intended to be used for filling bone defects and for bone augmentation.
• Geistlich Bio-Oss® Granules
Geistlich Bio-Oss® Granules is intended to be used for filling bone defects and for bone augmentation.

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus, Dept. of Periodontology	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vertical bone height. (mm) Changes in vertical bone height after transcrestal approach sinus augmentation.	Measuring the changes in vertical bone height after transcrestal approach sinus augmentation.	Pre op; immediately post-op and at 6 months.
Secondary	The success rate of osseointegrated implants. (%)	The percentage of osseointegrated implants that were installed with simultaneous transcrestal approach sinus augmentation.- using Bio-Oss collagen®.	At 6 months after intervention.
Secondary	Procedure time measurement. (min)	To evaluate the time needed for transcrestal approach sinus augmentation using Bio-Oss collagen® and in the conventional way, using Bio-Oss granules.	The procedure time measurement will start after flaps are elevated at pilot drilling (2.4mm diameter). and it will be stopped when the implant was inserted and insertion torque was assessed.
Secondary	Patients and operator satisfaction. (1-10 ruler scale)	To study operator and patients satisfaction using the 2 materials. They will be assessed by giving the patients questionnaires and satisfaction ruler using a 1-10 ruler scale.	At the suture removal visit - 14 days after procedure.
Secondary	Complications	Explore intra and post operative complications.	During the procedure, During the follow up - 14 days, 6 months after intervention.