Trial Outcomes & Findings for Immediate Function of NobelSpeedy Shorty and Brånemark System® Mk III Shorty Implants in Daily Use (NCT NCT02180230)

Last Updated: 2016-04-22

Results Overview

Marginal bone remodeling is calculated for each side of the implant (mesial and distal) separately, as the difference between bone levels at two time points. The average of mesial and distal remodeling is then calculated for each implant site (paired for each side between two different points). Negative numbers indicate bone loss. Implant insertion was defined as a baseline. Missing data was not imputed and not included in evaluation.

Recruitment status

COMPLETED

Study phase

Target enrollment

38 participants

Primary outcome timeframe

from implant insertion to 6, 12, 36 and 60 months

Results posted on

2016-04-22

Participant Flow

Participant milestones

Participant milestones
Measure	Shorty Implants Brånemark System Mk III Shorty and/or NobelSpeedy Shorty Shorty implants: Dental implant insertion to maxilla or mandible
Overall Study STARTED	38
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immediate Function of NobelSpeedy Shorty and Brånemark System® Mk III Shorty Implants in Daily Use

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Shorty Implants n=38 Participants Brånemark System Mk III Shorty and/or NobelSpeedy Shorty Shorty implants: Dental implant insertion to maxilla or mandible
Age, Continuous	52.2 years STANDARD_DEVIATION 4.39 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: from implant insertion to 6, 12, 36 and 60 months

Population: Intention to treat analysis (all participants who received at least one implant were analyzed). Missing data was not imputed and not included in evaluation.

Outcome measures

Outcome measures
Measure	Shorty Implants n=53 implants Brånemark System Mk III Shorty and NobelSpeedy Shorty Shorty implants: Dental implant insertion to maxilla or mandible
Marginal Bone Remodeling implant insertion to 6 months	-1.34 mm Standard Deviation 1.10
Marginal Bone Remodeling implant insertion to 12 months	-1.38 mm Standard Deviation 1.12
Marginal Bone Remodeling implant insertion to 36 months	-1.37 mm Standard Deviation 1.02
Marginal Bone Remodeling implant insertion to 60 months	-1.65 mm Standard Deviation 1.11

SECONDARY outcome

Timeframe: implant insertion to follow-up visits (6, 12, 36 and 60 months)

Population: Intention to treat analysis (all participants who received at least one implant were analyzed). Missing data was not imputed and not included in evaluation.

An implant was reported to be a surviving implant when it remained in the jaw and was functionally loaded even if not all the individual success criteria were fulfilled (i) an implant that causes no allergic, toxic or gross infectious reactions either locally or systemically, ii) offered anchorage to a functional prosthesis, iii) showed no signs of fracture or bending, iv) showed no signs of peri-implant radiolucency on an intraoral radiograph using a paralleling technique strictly perpendicular to the implant-bone interface, and v) showed no mobility when individually tested by either tapping or rocking with a hand instrument).

Outcome measures

Outcome measures
Measure	Shorty Implants n=86 implants Brånemark System Mk III Shorty and NobelSpeedy Shorty Shorty implants: Dental implant insertion to maxilla or mandible
Cumulative Survival Rates of the Implants 60 months	96.5 percentage of surviving implants
Cumulative Survival Rates of the Implants 36 months	97.7 percentage of surviving implants
Cumulative Survival Rates of the Implants 12 months	98.8 percentage of surviving implants
Cumulative Survival Rates of the Implants 6 months	98.8 percentage of surviving implants

Adverse Events

Shorty Implants

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Shorty Implants n=38 participants at risk Brånemark System Mk III Shorty and/or NobelSpeedy Shorty Shorty implants: Dental implant insertion to maxilla or mandible
Surgical and medical procedures Implant mobile	5.3% 2/38 • Number of events 2 • Adverse events were collected during the course of the study up to 5-years follow up.
Surgical and medical procedures Implant Out	5.3% 2/38 • Number of events 4 • Adverse events were collected during the course of the study up to 5-years follow up.
Surgical and medical procedures Prosthesis retaining screw fracture	2.6% 1/38 • Number of events 1 • Adverse events were collected during the course of the study up to 5-years follow up.
Surgical and medical procedures Prosthesis retaining screw loosening	7.9% 3/38 • Number of events 7 • Adverse events were collected during the course of the study up to 5-years follow up.
Injury, poisoning and procedural complications Hyperplasia	5.3% 2/38 • Number of events 2 • Adverse events were collected during the course of the study up to 5-years follow up.
Injury, poisoning and procedural complications Swelling	2.6% 1/38 • Number of events 1 • Adverse events were collected during the course of the study up to 5-years follow up.
Surgical and medical procedures Moving quick temporary abutment	2.6% 1/38 • Number of events 1 • Adverse events were collected during the course of the study up to 5-years follow up.
Surgical and medical procedures Bridge loosening	2.6% 1/38 • Number of events 1 • Adverse events were collected during the course of the study up to 5-years follow up.
Surgical and medical procedures Phoenetic difficulties	2.6% 1/38 • Number of events 1 • Adverse events were collected during the course of the study up to 5-years follow up.

Additional Information

Head of Clinical Trial Management

Nobel Biocare

Phone: +41 43 211 42 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place