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OpenTrials
Completed

NCT Number: NCT00426322

Efficacy of Sinus Floor Augmentation Using Large or Small Bovine Bone Mineral.

The aim of this clinical study is to compare the amount of newly formed bone after bone augmentation with Bio-Oss® (BO) 0.25-1 mm vs. Bio-Oss® (BO) 1-2 mm in the sinus floor augmentation procedure bilaterally in 8 patients.

Hypothesis:

There is no difference in the relative amount of newly formed bone plus BO between the large (1-2 mm) and small (0.25 - 1 mm) granules.

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Key information

Conditions

Sinus Graft

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hadassah Medical Organization

Jerusalem, Israel

About this study

the use of bovine bone mineral particles (Bio-Oss®)in sinus floor augmentation is well established. bovine bone mineral is an oseoconductive material which serves as a space maintainer and a scaffold for bone augmentation. the commercial product is manufactured in two different particles sizes, "large"1-2 mm, and "small"0.25-1 mm.

Comparison: the histologic characteristics of augmented bone after the use of Bio-Oss® (BO) with particle size of 0.25-1 mm vs. Bio-Oss® (BO)with particle size of 1-2 mm.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The patients included in this study are over 18 year old men and women.
  • The patient must be a candidate for sinus floor augmentation.
  • The patient is able to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures.
  • The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent.

Exclusion criteria

  • Pregnant women.
  • People who smoke more than 10 cigarettes a day.
  • Alcohol and drug abusers.
  • People suffering from uncontrolled diabetes, severe osteoporosis, rheumatic arthritis, precancer or neoplastic lesions of oral cavity.
  • The patient is nursing.

Treatment and study plan

bovine bone mineral particles (Bio-Oss®)

Device

bovine bone mineral particles used for sinus augmentation prior to dental implant placement

Other names: bovine bone mineral particles (Bio-Oss®) small particles, bovine bone mineral particles (Bio-Oss®) large particles

Primary outcomes

  1. the relative amount of mineralised tissue (=newly formed bone plus BO)

    Time frame: 20 monthes

Secondary outcomes

  1. Relative amount of newly formed bone, graft residues, bone marrow, residual bone and connective tissue.

    Time frame: 20 monthes

  2. Clinical parameters:

    Time frame: 32 monthes

  3. complications during surgery related to the material.

    Time frame: 20 monthes

  4. post-operative complications.

    Time frame: 20 monthes

  5. Max torque for implant insertion.

    Time frame: 20 monthes

  6. short-term implant survival (up to one year post loading)

    Time frame: 32 monthes

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Official study title

Efficacy of Sinus Floor Augmentation Using Large (1-2mm) or Small (0.25-1mm) Bovine Bone Mineral Particles (Bio-Oss®): A Comparative Histomorphometric Clinical Study

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 24, 2007
Registry last updated
Sep 10, 2013

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.