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NCT Number: NCT04581304

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Bone Loss Anodontia Bone Diseases Bone Diseases, Metabolic Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Metabolic Diseases Missing Teeth Musculoskeletal Diseases Nutritional and Metabolic Diseases Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rambam Health Care Campus, Dept. of Periodontology

Haifa, 31096, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Geistlich Bio-Oss® Collagen

Device

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

Geistlich Bio-Oss® Granules

Device

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

Primary outcomes

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

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

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

Secondary outcomes

  1. Procedure time measurement. (min)

    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.

    To evaluate the time needed for transcrestal approach sinus augmentation using Bio-Oss collagen® and in the conventional way, using Bio-Oss granules.

  2. Patients and operator satisfaction. (1-10 ruler scale)

    Time frame: At the suture removal visit - 14 days after procedure.

    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.

  3. Complications

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

    Explore intra and post operative complications.

  4. The success rate of osseointegrated implants. (%)

    Time frame: At 6 months and 3.5 years after intervention.

    The percentage of osseointegrated implants that were installed with simultaneous transcrestal approach sinus augmentation.- using Bio-Oss collagen®.

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2028
First posted
Oct 9, 2020
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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