Trial Outcomes & Findings for Study on OsseoSpeed™ TX Narrow Implants in the Lower Jaw in a Chinese Population (NCT NCT01473355)

NCT ID: NCT01473355

Last Updated: 2019-10-15

Results Overview

Implant survival rate evaluated by clinically and radiographically counting the number of implants remaining in function

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

45 participants

Primary outcome timeframe

Measured at the 3 year follow-up after implant loading.

Results posted on

2019-10-15

Participant Flow

Unit of analysis: Implants

Participant milestones

Participant milestones
Measure	OsseoSpeed™ TX OsseoSpeed™ TX narrow implant (diameter 3 mm) in lengths of 11-15 mm
Overall Study STARTED	45 75
Overall Study COMPLETED	39 65
Overall Study NOT COMPLETED	6 10

Reasons for withdrawal

Reasons for withdrawal
Measure	OsseoSpeed™ TX OsseoSpeed™ TX narrow implant (diameter 3 mm) in lengths of 11-15 mm
Overall Study Protocol Violation	2
Overall Study Adverse Event	2
Overall Study Lost to Follow-up	2

Baseline Characteristics

Study on OsseoSpeed™ TX Narrow Implants in the Lower Jaw in a Chinese Population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OsseoSpeed™ TX n=75 Implants OsseoSpeed™ TX narrow implants (diameter 3 mm) in lengths of 11-15 mm
Age, Continuous	52.5 years STANDARD_DEVIATION 11.86 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants
Region of Enrollment China	45 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at the 3 year follow-up after implant loading.

Population: All participants treated with at least one study implant.

Implant survival rate evaluated by clinically and radiographically counting the number of implants remaining in function

Outcome measures

Outcome measures
Measure	OsseoSpeed™ TX n=75 Implants OsseoSpeed™ TX narrow implants (diameter 3 mm) in lengths of 11-15 mm
Number of Survived Implants	74 Implants

SECONDARY outcome

Timeframe: Measured at the 3 year follow-up after implant loading.

Population: 39 subjects (65 implants) completed the 3-year follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 34 subjects (60 implants). Three of the radiographs were not possible to evaluate, giving an overall number of 32 subjects (57 implants) as basis for the Marginal Bone Level analysis.

Marginal bone level determined from radiographs and expressed as the distance 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=57 Implants OsseoSpeed™ TX narrow implants (diameter 3 mm) in lengths of 11-15 mm
Marginal Bone Level Alteration	-0.02 millimeter Standard Deviation 0.80

SECONDARY outcome

Timeframe: Measured at the 3 year follow-up after implant loading.

Population: 39 subjects (65 implants) completed the 3-year follow-up visit. Analysis of implant stability was performed on the all patients treated population.

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

Outcome measures

Outcome measures
Measure	OsseoSpeed™ TX n=65 Implants OsseoSpeed™ TX narrow implants (diameter 3 mm) in lengths of 11-15 mm
Number of Stable Implants	65 Implants

SECONDARY outcome

Timeframe: Measured at the 3 year follow-up after implant loading.

Population: 39 subjects (65 implants) completed the 3-year follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 34 subjects (60 implants) for the PPD analysis.

Condition of the periimplant mucosa by assessment of probing pocket depth (PPD). Change in pocket depth expressed in millimeters at the 3-year follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline). Negative value = increased pocket depth.

Outcome measures

Outcome measures
Measure	OsseoSpeed™ TX n=60 Implants OsseoSpeed™ TX narrow implants (diameter 3 mm) in lengths of 11-15 mm
Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD	-0.03 millimeter Standard Deviation 0.59

SECONDARY outcome

Timeframe: Measured at the 3 year follow-up after implant loading.

Population: 39 subjects (65 implants) completed the 3-year follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 34 subjects (60 implants) for the BoP analysis.

Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as % of implants that show presence of bleeding on probing at time of the 3-year follow-up visit.

Outcome measures

Outcome measures
Measure	OsseoSpeed™ TX n=60 Implants OsseoSpeed™ TX narrow implants (diameter 3 mm) in lengths of 11-15 mm
Evaluation of the Periimplant Mucosa Condition - By Assessment of BoP	33 Implants

SECONDARY outcome

Timeframe: Measured at the 3 year follow-up after implant loading.

Population: 39 subjects (65 implants) completed the 3-year follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 34 subjects (60 implants) for the plaque analysis.

Occurence of plaque around the study implant. Presented as number of implants that show presence of plaque at time of the 3 years follow-up visit after implant loading.

Outcome measures

Outcome measures
Measure	OsseoSpeed™ TX n=60 Implants OsseoSpeed™ TX narrow implants (diameter 3 mm) in lengths of 11-15 mm
Presence of Plaque	49 Implants

Adverse Events

OsseoSpeed™ TX

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	OsseoSpeed™ TX n=45 participants at risk OsseoSpeed™ TX narrow implants (diameter 3 mm) in lengths of 11-15 mm
Musculoskeletal and connective tissue disorders Fracture left leg	2.2% 1/45 • Number of events 1 • 3 year
Eye disorders Possible ablepsia of right eye	2.2% 1/45 • Number of events 1 • 3 year

Other adverse events

Adverse event data not reported

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