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

NCT04581304 | Active Not Recruiting DMC

• 1 other identifier: 0136-20-RMB CTIL
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Loss; Missing Teeth

Outcome Measures

Primary Outcomes (1)

• Vertical bone height. (mm)Changes in augmented bone after transcrestal approach sinus augmentation.

  Measuring the changes in augmented bone volume after transcrestal approach sinus augmentation.

  Pre op; immediately post-op, at 6 months and 3 years from second stage surgery.

Secondary Outcomes (4)

• Procedure time measurement. (min)

  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)

  At the suture removal visit - 14 days after procedure.

• Complications

  During the procedure, During the follow up - 14 days, 6 months after intervention.

• The success rate of osseointegrated implants. (%)

  At 6 months and 3.5 years after intervention.

Study Arms (2)

Bio-Oss Collagen

EXPERIMENTAL

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

Device: Geistlich Bio-Oss® Collagen

Bio-Oss Granules

ACTIVE COMPARATOR

Transcrestal approach sinus augmentation using Geistlich Bio-Oss®.

Device: Geistlich Bio-Oss® Granules

Interventions

Geistlich Bio-Oss® Collagen DEVICE

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

Bio-Oss Collagen

Geistlich Bio-Oss® Granules DEVICE

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

Bio-Oss Granules

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Health Care Campus, Dept. of Periodontology

Haifa, 31096, Israel

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic; Anodontia

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Hadar Zigdon, DMD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rambam Health Care Campus

Study Record Dates

• First Submitted: October 4, 2020
• First Posted: October 9, 2020
• Study Start: October 15, 2020
• Primary Completion (Estimated): December 17, 2026
• Study Completion (Estimated): January 17, 2028
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

IL (1)