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

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: Completed
• Conditions: Jaw, Edentulous, Partially; Jaw, Edentulous
• Intervention / Treatment: Device: Straumann BoneCeramic; Device: Bio-Oss

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: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change of Vertical Height of Buccal Defects	Change of vertical height of buccal defects over 26 weeks, measured during 1st - and 2nd- stage surgery	Baseline to 26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant Success Rate	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	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	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	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

• Sponsor: Institut Straumann AG
• Investigators: Principal Investigator: Marc Quirynen, Professor, KU Leuven

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: May 11, 2009
• First Submitted That Met QC Criteria: May 12, 2009
• First Posted (Estimate): May 13, 2009

Study Record Updates

• Last Update Posted (Estimate): March 30, 2016
• Last Update Submitted That Met QC Criteria: March 2, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Mouth, Edentulous; Jaw, Edentulous; Jaw, Edentulous, Partially
• Other Study ID Numbers: CR 04/05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No