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

March 2, 2016 updated by: Institut Straumann AG

A Randomised Controlled Spilt-mouth Clinical Study Comparing a Synthetic Bone Substitute and a Bovine-derived Xenograft in Primarily Horizontal Bone Augmentation Procedure During Placement of Straumann Oral Implants

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Katholieke Universiteit Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Straumann BoneCeramic
Device: Straumann BoneCeramic
Bone augmentation procedure performed with Bone Ceramic
Active Comparator: Bio-Oss
Geistlich Bio-Oss
Device: Bio-Oss
Bone Augmentation procedure performed with Bio Oss

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of Vertical Height of Buccal Defects
Time Frame: Baseline to 26 weeks
Change of vertical height of buccal defects over 26 weeks, measured during 1st - and 2nd- stage surgery
Baseline to 26 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Implant Success Rate
Time Frame: 6 months

The success of oral implant will be determined according to the following parameters:

  • Absence of any continuous peri-implant radiolucency based on radiographic findings.
  • Absence of implant mobility (based on hand testing)
  • Absence of a peri-implant infection with suppuration.
  • Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics).
  • Bone level changes evaluated on periapical radiographs around implants less than 1 mm during the first year of loading, starting at abutment connection.
6 months
Implant Survival Rate
Time Frame: 6 Months

A surviving implant will be considered an implant fulfilling the following criteria:

  • Absence of any continuous peri-implant radiolucency based on radiographic findings.
  • Absence of implant mobility.
  • Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics).
  • Absence of pain or any other adverse observation by the patient, so that the implant has to be removed.
6 Months
Implant Success Rate
Time Frame: 12 months

The success of oral implant will be determined according to the following parameters:

  • Absence of any continuous peri-implant radiolucency based on radiographic findings.
  • Absence of implant mobility (based on hand testing)
  • Absence of a peri-implant infection with suppuration.
  • Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics).
  • Bone level changes evaluated on periapical radiographs around implants less than 1 mm during the first year of loading, starting at abutment connection.
12 months
Implant Survival Rate
Time Frame: 12 months

A surviving implant will be considered an implant fulfilling the following criteria:

  • Absence of any continuous peri-implant radiolucency based on radiographic findings.
  • Absence of implant mobility.
  • Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics).
  • Absence of pain or any other adverse observation by the patient, so that the implant has to be removed.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut Straumann AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marc Quirynen, Professor, KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR 04/05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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