Comparison of Synthetic Bone Substitute and a Bovine-derived Xenograft in Horizontal Bone Augmentation

NCT ID: NCT00901017

Last Updated: 2016-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2008-08-31

Brief Summary

The objective of the study is to test the efficacy on bone formation of Straumann Bone Ceramic as a grafting material applied in buccal bone dehiscences on simultaneously placed oral implants.

Detailed Description

This is a randomized, controlled, split mouth, prospective, single centre study. The total study duration for each patient should be 76 weeks +/-18 months.

In total 8 visits per patient are scheduled in this study.

The study devices Straumann Bone Ceramic and Bio-Oss are CE-marked, and approved by the FDA. The products are used within the indication.

One center in Beligum will participate.

Conditions

Jaw, Edentulous; Jaw, Edentulous, Partially

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Straumann BoneCeramic

Straumann BoneCeramic

Group Type: ACTIVE_COMPARATOR

Straumann BoneCeramic

Intervention Type: DEVICE

Bone augmentation procedure performed with Bone Ceramic

Bio-Oss

Geistlich Bio-Oss

Group Type: ACTIVE_COMPARATOR

Bio-Oss

Intervention Type: DEVICE

Bone Augmentation procedure performed with Bio Oss

Interventions

Straumann BoneCeramic

Bone augmentation procedure performed with Bone Ceramic

Intervention Type: DEVICE

Bio-Oss

Bone Augmentation procedure performed with Bio Oss

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Males and females, 18 years to 80 years of age
• At least two missing teeth up to full edentulous arches.
• Desiring implant supported restorations.
• Both study implants should have a self-containing (2-wall) buccal dehiscence defect after oral implant placement (at least 3.0 mm / max. 5.0 mm defect in apico-coronal aspect to be measured from the boarder of the rough surface of the oral implant to the bottom of the defect).
• At least 4mm of the implant, measured from the apical end to the lowest margin of the bone level, should be covered with bone.
• Sufficient bone volume such that both oral implants will not encroach on vital structures and primary stability of the oral implant can be achieved;
• Patients must be committed to the study and must sign informed consent.
• Patient in good general health as documented by self assessment;
• Full mouth plaque score of <20%;

Exclusion Criteria

• Any systemic medical condition that could interfere with the surgical procedure or planned treatment;
• Current pregnancy or breast feeding/ lactating at the time of recruitment;
• Physical handicaps that would interfere with the ability to perform adequate oral hygiene;
• Alcoholism or chronically drug abuse causing systemic compromise.
• Patients who smoke more than 20 cigarettes per day.
• Conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for surgical procedure or would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability
• Lack of primary stability of 1 or both implant(s) at surgery, measured by hand testing. In this instance the patient must be withdrawn and treated accordingly.
• Mucosal diseases such as erosive lichen planus
• History of local radiation therapy.
• Presence of osseous pathologies.
• Presence of oral lesions (such as ulceration, malignancy)
• Severe bruxing or clenching habits.
• Local inflammation, including untreated periodontitis.
• Bone surgery at the implant site(s) (bone grafts, guided tissue regeneration techniques for bone enhancement) prior to implant placement unless performed more than 6 months prior to implant placement.
• Patients presenting clinical and radiological signs and symptoms of maxillary sinus disease.
• Existing teeth in the residual dentition with untreated endodontic pathologies.
• Patients with inadequate oral hygiene or unmotivated for adequate home care

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Straumann AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Quirynen, Professor

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

Katholieke Universiteit Leuven

Leuven, , Belgium

Countries

Belgium

Other Identifiers

CR 04/05

Identifier Type: -

Identifier Source: org_study_id