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

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

Study Overview

• Status: Recruiting
• Conditions: Bone Loss; Missing Teeth
• Intervention / Treatment: Device: Geistlich Bio-Oss® Collagen; Device: Geistlich Bio-Oss® Granules

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Prof Hadar Zigdon, DMD; Phone Number: 9727772983; Email: h_zigdon@rambam.health.gov.il
• Study Contact Backup: Name: Dr Eran Gabay, DMD; Phone Number: 9727772983; Email: eran.gabay@mail.huji.ac.il

Study Locations

• Israel
  • Haifa, Israel, 31096
    • Recruiting
    • Rambam Health Care Campus, Dept. of Periodontology
    • Contact: Prof. Hadar Zigdon, DMD; Email: h_zigdon@rambam.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bio-Oss Collagen; Transcrestal approach sinus augmentation using Geistlich Bio-Oss Collagen®.	Device: Geistlich Bio-Oss® Collagen; Geistlich Bio-Oss® Collagen is intended to be used for filling bone defects and for bone augmentation.
Active Comparator: Bio-Oss Granules; Transcrestal approach sinus augmentation using Geistlich Bio-Oss®.	Device: Geistlich Bio-Oss® Granules; Geistlich Bio-Oss® Granules is intended to be used for filling bone defects and for bone augmentation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
Complications	Explore intra and post operative complications.	During the procedure, During the follow up - 14 days, 6 months after intervention.

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Anticipated): September 16, 2023
• Study Completion (Anticipated): February 16, 2024

Study Registration Dates

• First Submitted: October 4, 2020
• First Submitted That Met QC Criteria: October 4, 2020
• First Posted (Actual): October 9, 2020

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: April 2, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Tooth Abnormalities; Tooth Loss; Anodontia
• Other Study ID Numbers: 0136-20-RMB CTIL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No