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

• Sponsor: Institut Straumann AG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00901017
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arms: 2
• Duration (Months): 29
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Jaw, Edentulous; Jaw, Edentulous, Partially	Device: Straumann BoneCeramic; Device: Bio-Oss	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Mar 1, 2006
• Actual Primary Completion Date: Feb 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Straumann BoneCeramic 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

Outcome Measures

Primary Outcome Measures

1. Change of Vertical Height of Buccal Defects [Baseline to 26 weeks]

   Change of vertical height of buccal defects over 26 weeks, measured during 1st - and 2nd- stage surgery

Secondary Outcome Measures

1. Implant Success Rate [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.

2. Implant Survival Rate [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.

3. Implant Success Rate [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.

4. Implant Survival Rate [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Katholieke Universiteit Leuven	Leuven		Belgium	3000

Sponsors and Collaborators

• Institut Straumann AG

Investigators

• Principal Investigator: Marc Quirynen, Professor, KU Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institut Straumann AG
• ClinicalTrials.gov Identifier: NCT00901017
• Other Study ID Numbers: CR 04/05
• First Posted: May 13, 2009
• Last Update Posted: Mar 30, 2016
• Last Verified: Mar 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Jaw, Edentulous; Jaw, Edentulous, Partially; Mouth, Edentulous

Study Results

Participant Flow

Arm/Group Title	Straumann BoneCeramic and Geistlich Bio-Oss
Arm/Group Description	Each patient received both treatments in a split-mouth design.
Period Title: Overall Study
STARTED	14
COMPLETED	14
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Straumann BoneCeramic and Geistlich Bio-Oss
Arm/Group Description	Each patient received both treatments in a split-mouth design.
Overall Participants	14
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	12 85.7%
>=65 years	2 14.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.1 (9.9)
Sex: Female, Male (Count of Participants)
Female	12 85.7%
Male	2 14.3%
Region of Enrollment (participants) [Number]
Belgium	14 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

14 patients represented the ITT population.

Arm/Group Title	Straumann BoneCeramic	Geistlich Bio-Oss
Arm/Group Description	In the test site the bone grafting procedure will be done with a synthetic biphasic calcium phosphate in particulate form (Straumann Bone Ceramic, Institute Straumann AG, Switzerland).	The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland).
Measure Participants	14	14
Mean (95% Confidence Interval) [mm]	-4.5	-4.82

2. Secondary Outcome

Title	Implant Success Rate
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Straumann BoneCeramic	Geistlich Bio-Oss
Arm/Group Description	In the test site the bone grafting procedure will be done with a synthetic biphasic calcium phosphate in particulate form (Straumann Bone Ceramic, Institute Straumann AG, Switzerland).	The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland)
Measure Participants	14	14
Number [% of implants]	100	100

3. Secondary Outcome

Title	Implant Survival Rate
Description	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.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Straumann BoneCeramic	Geistlich Bio-Oss
Arm/Group Description	In the test site the bone grafting procedure will be done with a synthetic biphasic calcium phosphate in particulate form (Straumann Bone Ceramic, Institute Straumann AG, Switzerland).	The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland)
Measure Participants	14	14
Number [% of implants]	100	100

4. Secondary Outcome

Title	Implant Success Rate
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Straumann BoneCeramic	Geistlich Bio-Oss
Arm/Group Description	In the test site the bone grafting procedure will be done with a synthetic biphasic calcium phosphate in particulate form (Straumann Bone Ceramic, Institute Straumann AG, Switzerland).	The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland)
Measure Participants	14	14
Number [% of implants]	100	100

5. Secondary Outcome

Title	Implant Survival Rate
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Straumann BoneCeramic	Geistlich Bio-Oss
Arm/Group Description	In the test site the bone grafting procedure will be done with a synthetic biphasic calcium phosphate in particulate form (Straumann Bone Ceramic, Institute Straumann AG, Switzerland).	The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland)
Measure Participants	14	14
Number [% of implants]	100	100

Adverse Events

Arm/Group Title	Straumann BoneCeramic		Geistlich Bio-Oss
Arm/Group Description	In the test site the bone grafting procedure will be done with a synthetic biphasic calcium phosphate in particulate form (Straumann Bone Ceramic, Institute Straumann AG, Switzerland).		The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland).
All Cause Mortality
	Straumann BoneCeramic		Geistlich Bio-Oss
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Straumann BoneCeramic		Geistlich Bio-Oss
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Straumann BoneCeramic		Geistlich Bio-Oss
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/14 (21.4%)		3/14 (21.4%)
General disorders
Membrane necrosis	1/14 (7.1%)	1	1/14 (7.1%)	1
Perforation	1/14 (7.1%)	1	1/14 (7.1%)	1
Candida	2/14 (14.3%)	2	2/14 (14.3%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.