Trial Outcomes & Findings for Straumann Bone Ceramic Versus BioOss in Sinus Elevation (NCT NCT00900822)

Results Overview

Results from morphometric measurements of percentage of new bone in contact with the total surface of the titanium implant, area of new bone and bone graft particles in contact with bone

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

9 months after implant placement

Results posted on

2016-03-31

Participant Flow

Recruitment started Oct 2005 and was completed June 2006.

Split-mouth design (test and control in the same patient).

Participant milestones

Participant milestones
Measure	Straumann BoneCeramic Synthetic bone graft material
9 Months Histological Evaluation STARTED	11
9 Months Histological Evaluation COMPLETED	11
9 Months Histological Evaluation NOT COMPLETED	0
12 Months Clinical Evaluation STARTED	11
12 Months Clinical Evaluation COMPLETED	11
12 Months Clinical Evaluation NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Straumann Bone Ceramic Versus BioOss in Sinus Elevation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Straumann Bone Ceramic n=11 Participants Synthetic bone graft material
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	65.27 years STANDARD_DEVIATION 9.06 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment Sweden	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 9 months after implant placement

Population: This was a split-mouth design. Each patient received both treatments. There was one sample in the Straumann BoneCeramic group that could not be analyzed.

Results from morphometric measurements of percentage of new bone in contact with the total surface of the titanium implant, area of new bone and bone graft particles in contact with bone

Outcome measures

Outcome measures
Measure	Straumann Bone Ceramic n=10 Participants Synthetic bone graft material	BioOss n=11 Participants Xenograft bone graft material
Histologically Measured Bone to Implant Contact (BIC)	64.552 percentage of total surface Standard Deviation 9.036	54.904 percentage of total surface Standard Deviation 15.995

SECONDARY outcome

Timeframe: 12 months after loading the implant

The percentage of implants remaining in the jaw.

Outcome measures

Outcome measures
Measure	Straumann Bone Ceramic n=11 Participants Synthetic bone graft material	BioOss n=11 Participants Xenograft bone graft material
Implant Survival Rate	96.7 percentage of implants	96.7 percentage of implants

SECONDARY outcome

Timeframe: 12 months after loading the implant

Implant success is defined as the absence of any continuous peri-implant radiolucency based on radiographic findings, absence of implant mobility, absence of a recurrent per-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more 3-month follow-up visits after treatment with systemic antibiotics), and bone level changes around the implant less than 1 mm during the first year of loading and less than 0.2 mm per year thereafter.

Outcome measures

Outcome measures
Measure	Straumann Bone Ceramic n=11 Participants Synthetic bone graft material	BioOss n=11 Participants Xenograft bone graft material
Implant Success Rate	93.6 percentage of implants	96.8 percentage of implants

Adverse Events

Straumann Bone Ceramic

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

BioOss

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Straumann Bone Ceramic n=11 participants at risk Synthetic bone graft material	BioOss n=11 participants at risk Xenograft bone graft material
General disorders Exposure of implant	9.1% 1/11 • Number of events 1 • 3 years	9.1% 1/11 • Number of events 1 • 3 years
General disorders Implant infection	9.1% 1/11 • Number of events 1 • 3 years	0.00% 0/11 • 3 years
General disorders Mobile implant	0.00% 0/11 • 3 years	9.1% 1/11 • Number of events 1 • 3 years
General disorders Fenestration of implant	0.00% 0/11 • 3 years	9.1% 1/11 • Number of events 1 • 3 years
General disorders Sinusitis	9.1% 1/11 • Number of events 1 • 3 years	0.00% 0/11 • 3 years
General disorders Contact between cover screw and prosthesis	0.00% 0/11 • 3 years	9.1% 1/11 • Number of events 1 • 3 years

Additional Information

Clinial Trial Manager

Institut Straumann AG

Phone: +41 61 965 11 11

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place