Trial Outcomes & Findings for Study on OsseoSpeed™ TX Implants in a Chinese Population (NCT NCT01346683)

Results Overview

Marginal Bone Level determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal Bone Level expressed in millimeters at the 3 year follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

45 participants

Primary outcome timeframe

Evaluated 3 years after implant loading

Results posted on

2019-09-27

Participant Flow

Unit of analysis: Implants

Participant milestones

Participant milestones
Measure	OsseoSpeed TX OsseoSpeed TX implants of lengths 8-17 mm
Overall Study STARTED	45 107
Overall Study COMPLETED	45 107
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study on OsseoSpeed™ TX Implants in a Chinese Population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OsseoSpeed TX n=107 Implants OsseoSpeed TX implants of lengths 8-17 mm
Age, Continuous	55.5 years STANDARD_DEVIATION 10.21 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Region of Enrollment China	45 participants n=5 Participants

PRIMARY outcome

Timeframe: Evaluated 3 years after implant loading

Population: Protocol deviations excluded, a total of 5 subjects (15 implants), resulting in a per protocol analysis population of 40 subjects (92 implants). In addition a total of 2 subjects (4 implants) had radiographs were not possible measure. Giving an analysis population of 38 subjects (88 implants) for the primary outcome measure.

Marginal Bone Level determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal Bone Level expressed in millimeters at the 3 year follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline).

Outcome measures

Outcome measures
Measure	OsseoSpeed TX n=88 Implants OsseoSpeed TX implants of lengths 8-17 mm
Marginal Bone Level Alteration	0.10 millimeter Standard Deviation 0.61

SECONDARY outcome

Timeframe: From implant placement to the follow-up 36 months after loading.

Population: Protocol deviations excluded, a total of 5 subjects (15 implants), resulting in a per protocol analysis population of 40 subjects (92 implants).

Implant survival rate evaluated clinically and radiographically.

Outcome measures

Outcome measures
Measure	OsseoSpeed TX n=92 Implants OsseoSpeed TX implants of lengths 8-17 mm
Implant Survival	92 Implants

SECONDARY outcome

Timeframe: Measured from loading of implants to the follow-up 36 months after loading.

Population: Protocol deviations excluded, a total of 5 subjects (15 implants), resulting in a per protocol analysis population of 40 subjects (92 implants).

Implant stability evaluated clinically/manually (recorded as stable yes/no)

Outcome measures

Outcome measures
Measure	OsseoSpeed TX n=92 Implants OsseoSpeed TX implants of lengths 8-17 mm
Implant Stability	92 Implants

SECONDARY outcome

Timeframe: Measured from loading of implants to the follow-up 36 months after loading.

Population: Protocol deviations excluded, a total of 5 subjects (15 implants), resulting in a per protocol analysis population of 40 subjects (92 implants).

Soft tissue status measured by assessment of probing pocket depth (PPD). PPD was measured at 4 different surfaces (mesial, distal, buccal and lingual) and change compared to baseline (loading) was analyzed. A negative value = increased pocket depth.

Outcome measures

Outcome measures
Measure	OsseoSpeed TX n=92 Implants OsseoSpeed TX implants of lengths 8-17 mm
Soft Tissue Status (PPD).	-0.77 millimeter Standard Deviation 0.95

SECONDARY outcome

Timeframe: Measured from loading of implants to the follow-up 36 months after loading.

Population: Protocol deviations excluded, a total of 5 subjects (15 implants), resulting in a per protocol analysis population of 40 subjects (92 implants).

Soft tissue status measured by assessment of bleeding on probing (BoP).

Outcome measures

Outcome measures
Measure	OsseoSpeed TX n=92 Implants OsseoSpeed TX implants of lengths 8-17 mm
Soft Tissue Status (BoP)	30 Implants

Adverse Events

OsseoSpeed TX

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	OsseoSpeed TX n=45 participants at risk OsseoSpeed TX implants of lengths 8-17 mm
Cardiac disorders Atrial Fibrillation	2.2% 1/45 • Number of events 1 • 3 years

Other adverse events

Other adverse events
Measure	OsseoSpeed TX n=45 participants at risk OsseoSpeed TX implants of lengths 8-17 mm
Infections and infestations Common cold	6.7% 3/45 • Number of events 5 • 3 years

Additional Information

Manager Global Clinical Research

Dentsply Sirona Implants, Mölndal, SWEDEN

Phone: 0046313763500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60