Trial Outcomes & Findings for Comparison of Synthetic Bone Substitute and a Bovine-derived Xenograft in Horizontal Bone Augmentation (NCT NCT00901017)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

14 participants

Primary outcome timeframe

Baseline to 26 weeks

Results posted on

2016-03-30

Participant Flow

Participant milestones

Participant milestones
Measure	Straumann BoneCeramic and Geistlich Bio-Oss Each patient received both treatments in a split-mouth design.
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Straumann BoneCeramic and Geistlich Bio-Oss n=14 Participants Each patient received both treatments in a split-mouth design.
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	55.1 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment Belgium	14 participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 26 weeks

Population: 14 patients represented the ITT population.

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

Outcome measures

Outcome measures
Measure	Straumann BoneCeramic n=14 Participants 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).	Geistlich Bio-Oss n=14 Participants The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland).
Change of Vertical Height of Buccal Defects	-4.5 mm Interval -5.8 to -3.2	-4.82 mm Interval -5.9 to -3.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Straumann BoneCeramic n=14 Participants 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).	Geistlich Bio-Oss n=14 Participants The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland).
Implant Success Rate	100 % of implants	100 % of implants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Straumann BoneCeramic n=14 Participants 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).	Geistlich Bio-Oss n=14 Participants The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland).
Implant Survival Rate	100 % of implants	100 % of implants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Straumann BoneCeramic n=14 Participants 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).	Geistlich Bio-Oss n=14 Participants The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland).
Implant Success Rate	100 % of implants	100 % of implants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Straumann BoneCeramic n=14 Participants 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).	Geistlich Bio-Oss n=14 Participants The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland).
Implant Survival Rate	100 % of implants	100 % of implants

Adverse Events

Straumann BoneCeramic

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Geistlich Bio-Oss

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Straumann BoneCeramic n=14 participants at risk 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).	Geistlich Bio-Oss n=14 participants at risk The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland).
General disorders Membrane necrosis	7.1% 1/14 • Number of events 1	7.1% 1/14 • Number of events 1
General disorders Perforation	7.1% 1/14 • Number of events 1	7.1% 1/14 • Number of events 1
General disorders Candida	14.3% 2/14 • Number of events 2	14.3% 2/14 • Number of events 2

Additional Information

Marc Quirynen, Professor

Institut Straumann AG

Phone: +4161965

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60