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Status unknownNCT02384291Updated Jul 16, 2019

Sinus Floor Elevation Using Alpha-Bio's GRAFT Natural Bovine Bone vs. Commercially Available Bone Graft

An interventional study of Alpha-Bio GRAFT Natural Bovine Bone and natural bone substitute in Sinus Floor Augmentation, sponsored by Alpha - Bio Tec Ltd.. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-16.

Sponsored by Alpha - Bio Tec Ltd. · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This clinical study is designed to compare the regenerative outcome of using separately two different Xenografts during sinus floor augmentation.

Aim of this prospective randomized-controlled clinical trial is to compare the regenerative results of Alpha-Bio's GRAFT Natural Bovine Bone versus commercially available bone graft after two-step sinus floor elevations by clinical and histological analysis.

Clinical Parameters are wound healing parameters, radiological volume stability and implant survival rates. Histological parameters are based on a histomorphometrical analysis of trephine cores harvested in progress of implant bed preparation.

02

Conditions studied

  • Sinus Floor Augmentation
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In context

Lead sponsor

Alpha - Bio Tec Ltd. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients who will present with a moderately or severely atrophic posterior maxilla with 1-6 mm residual alveolar bone will be selected for the study.
  2. Men and women over the age of 18 years.
  3. Patient has signed the Informed Consent.

Exclusion criteria

Exclusion Criteria:

  1. Chronic steroid therapy,
  2. Uncontrolled diabetes,
  3. Cardiovascular disease,
  4. Past irradiation of head and neck
  5. Maxillary sinus cysts,
  6. Active chronic sinusitis,
  7. Smoking more than ten cigarettes per day during the 3 months preceding this study .
  8. Malignant disease in the 5 years preceding this study
  9. Uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia
  10. Disease that compromise the immune system
  11. Psychiatric disorder
  12. Hypersensitivity to titanium, collagen or bovine bone.
  13. Women who are pregnant or nursing.
  14. Patients with non-treated periodontal disease.
  15. Medical and/or general contraindications for intraoral surgical procedures
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    Alpha-Bios GRAFT Natural Bovine Bone treatment

    Pure Hydroxyapatite ceramic mineral with high similarity to the human bone

    Device: Alpha-Bio GRAFT Natural Bovine Bone

  • Active comparator
    natural bone substitute

    natural bone substitute material derived from the mineral portion of bovine bone

    Device: natural bone substitute

Interventions

  • DeviceAlpha-Bio GRAFT Natural Bovine Bone

    Pure Hydroxyapatite ceramic mineral with high similarity to the human bone

  • Devicenatural bone substitute

    natural bone substitute material derived from the mineral portion of bovine bone

06

What researchers measure

Primary outcomes

  1. Histological bone formation following sinus floor augmentation [ evaluated by biopsies harvested from the implant sites]

    Time frame: 6 months

Secondary outcomes

  1. Bone volume-stable results six months following augmentation procedures [ demonstrated by X-ray evaluation].

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02384291
Lead sponsor
Alpha - Bio Tec Ltd.
Responsible party
Sponsor
First posted
Mar 10, 2015
Start date
May 2014
Primary completion
Dec 2019 (estimated)
Completion
Jun 2020 (estimated)
Last update
Jul 16, 2019

Study contacts

Daniel Rothamel, Priv-Doz Dr.
principal investigator · Department of Craniomaxillofacial and Plastic Surgery University Hospital of Cologne

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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