Comparison of Synthetic Bone Substitute and a Bovine-deri... | NCT00901017

NCT00901017

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Label	Type	Description	Intervention Names
Straumann BoneCeramic	Active Comparator	Straumann BoneCeramic	Device: Straumann BoneCeramic
Bio-Oss	Active Comparator	Geistlich Bio-Oss	Device: Bio-Oss

Name	Type	Description	Arm Group Labels	Other Names
Straumann BoneCeramic	Device	Bone augmentation procedure performed with Bone Ceramic	Straumann BoneCeramic

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Eligibility Module

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

Name	Affiliation	Role
Marc Quirynen, Professor	KU Leuven	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Katholieke Universiteit Leuven		Leuven		3000	Belgium

ID	Title	Description
FG000	Straumann BoneCeramic and Geistlich Bio-Oss	Each patient received both treatments in a split-mouth design.

Baseline Characteristics Module

ID	Title	Description
BG000	Straumann BoneCeramic and Geistlich Bio-Oss	Each patient received both treatments in a split-mouth design.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change of Vertical Height of Buccal Defects

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

14 patients represented the ITT population.

Posted

Mean

95% Confidence Interval

Baseline to 26 weeks

ID	Title	Description
OG000	Straumann BoneCeramic	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).
OG001	Geistlich Bio-Oss	The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland).

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Straumann BoneCeramic	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).

ID	Term
D007575	Jaw, Edentulous
D007576	Jaw, Edentulous, Partially

ID	Term
D007571	Jaw Diseases
D009140	Musculoskeletal Diseases
D009057	Stomatognathic Diseases
D009066	Mouth, Edentulous