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

Primary Purpose

Bone Loss, Missing Teeth

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Geistlich Bio-Oss® Collagen
Geistlich Bio-Oss® Granules
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Loss

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Rambam Health Care Campus, Dept. of PeriodontologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bio-Oss Collagen

Bio-Oss Granules

Arm Description

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

Transcrestal approach sinus augmentation using Geistlich Bio-Oss®.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The success rate of osseointegrated implants. (%)
The percentage of osseointegrated implants that were installed with simultaneous transcrestal approach sinus augmentation.- using Bio-Oss collagen®.
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.
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.
Complications
Explore intra and post operative complications.

Full Information

First Posted
October 4, 2020
Last Updated
April 2, 2023
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT04581304
Brief Title
The Use of Bio-Oss Collagen for Sinus Augmentation Using the Transcrestal Approach.
Official Title
The Use of Bio-Oss Collagen for Sinus Augmentation Using the Transcrestal Approach.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
September 16, 2023 (Anticipated)
Study Completion Date
February 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Loss, Missing Teeth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bio-Oss Collagen
Arm Type
Experimental
Arm Description
Transcrestal approach sinus augmentation using Geistlich Bio-Oss Collagen®.
Arm Title
Bio-Oss Granules
Arm Type
Active Comparator
Arm Description
Transcrestal approach sinus augmentation using Geistlich Bio-Oss®.
Intervention Type
Device
Intervention Name(s)
Geistlich Bio-Oss® Collagen
Intervention Description
Geistlich Bio-Oss® Collagen is intended to be used for filling bone defects and for bone augmentation.
Intervention Type
Device
Intervention Name(s)
Geistlich Bio-Oss® Granules
Intervention Description
Geistlich Bio-Oss® Granules is intended to be used for filling bone defects and for bone augmentation.
Primary Outcome Measure Information:
Title
Vertical bone height. (mm) Changes in vertical bone height after transcrestal approach sinus augmentation.
Description
Measuring the changes in vertical bone height after transcrestal approach sinus augmentation.
Time Frame
Pre op; immediately post-op and at 6 months.
Secondary Outcome Measure Information:
Title
The success rate of osseointegrated implants. (%)
Description
The percentage of osseointegrated implants that were installed with simultaneous transcrestal approach sinus augmentation.- using Bio-Oss collagen®.
Time Frame
At 6 months after intervention.
Title
Procedure time measurement. (min)
Description
To evaluate the time needed for transcrestal approach sinus augmentation using Bio-Oss collagen® and in the conventional way, using Bio-Oss granules.
Time Frame
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.
Title
Patients and operator satisfaction. (1-10 ruler scale)
Description
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.
Time Frame
At the suture removal visit - 14 days after procedure.
Title
Complications
Description
Explore intra and post operative complications.
Time Frame
During the procedure, During the follow up - 14 days, 6 months after intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Prof Hadar Zigdon, DMD
Phone
9727772983
Email
h_zigdon@rambam.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Eran Gabay, DMD
Phone
9727772983
Email
eran.gabay@mail.huji.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hadar Zigdon, DMD
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Health Care Campus, Dept. of Periodontology
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof. Hadar Zigdon, DMD
Email
h_zigdon@rambam.health.gov.il

12. IPD Sharing Statement

Learn more about this trial

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

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