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

NCT02384291 | Unknown DMC

• 1 other identifier: ABT-BG-01
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Sinus Floor Augmentation

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (1)

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

  6 months

Study Arms (2)

Alpha-Bios GRAFT Natural Bovine Bone treatment

EXPERIMENTAL

Pure Hydroxyapatite ceramic mineral with high similarity to the human bone

Device: Alpha-Bio GRAFT Natural Bovine Bone

natural bone substitute

ACTIVE COMPARATOR

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

Device: natural bone substitute

Interventions

Alpha-Bio GRAFT Natural Bovine Bone DEVICE

Pure Hydroxyapatite ceramic mineral with high similarity to the human bone

Alpha-Bios GRAFT Natural Bovine Bone treatment

natural bone substitute DEVICE

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

natural bone substitute

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Men and women over the age of 18 years.
• Patient has signed the Informed Consent.

You may not qualify if:

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

Sponsors & Collaborators

• Alpha - Bio Tec Ltd.: lead

Related Links

• Sponsor site

Study Officials

• Daniel Rothamel, Priv-Doz Dr.

  Department of Craniomaxillofacial and Plastic Surgery University Hospital of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: March 10, 2015
• Study Start: May 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: July 16, 2019

Record last verified: 2018-09