Trial Outcomes & Findings for Study on OsseoSpeed™ TX Implants in the Upper Jaw in a Chinese Population (NCT NCT01389245)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

42 participants

Primary outcome timeframe

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

Results posted on

2020-05-06

Participant Flow

Unit of analysis: Implants

Participant milestones

Participant milestones
Measure	OsseoSpeed™ TX OsseoSpeed™ TX implants of lengths 8-17 mm
Overall Study STARTED	42 110
Overall Study COMPLETED	27 66
Overall Study NOT COMPLETED	15 44

Reasons for withdrawal

Reasons for withdrawal
Measure	OsseoSpeed™ TX OsseoSpeed™ TX implants of lengths 8-17 mm
Overall Study Protocol Violation	10
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OsseoSpeed™ TX n=86 Implants OsseoSpeed™ TX implants of lengths 8-17 mm
Age, Continuous	56.0 Years STANDARD_DEVIATION 11.3 • n=93 Participants
Sex: Female, Male Female	14 Participants n=93 Participants
Sex: Female, Male Male	18 Participants n=93 Participants
Region of Enrollment China	32 Participants n=93 Participants

PRIMARY outcome

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

Population: 36 subjects (86 implants) completed the 3-year follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 27 subjects (66 implants). Eighteen of the radiographs were not possible to evaluate, giving an overall number of 19 subjects (48 implants) as basis for the 3-year Marginal Bone Level alteration 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=48 Implants OsseoSpeed™ TX implants of lengths 8-17 mm
Marginal Bone Level Alteration	-0.09 Millimeter Standard Deviation 0.83

SECONDARY outcome

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

Population: 36 subjects (86 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=86 Implants OsseoSpeed™ TX implants of lengths 8-17 mm
Number of Stable Implants	86 Implants

SECONDARY outcome

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

Population: 36 subjects (86 implants) completed the 3-year follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 27 subjects (66 implants). For two of those implants evaluation of PPD was not performed, giving 25 subjects (64 implants) as basis 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=64 Implants OsseoSpeed™ TX implants of lengths 8-17 mm
Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD	-0.23 Millimeter Standard Deviation 0.90

SECONDARY 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=110 Implants OsseoSpeed™ TX implants of lengths 8-17 mm
Number of Survived Implants	103 Implants

SECONDARY outcome

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

Population: 36 subjects (86 implants) completed the 3-year follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 27 subjects (66 implants). Evaluation of plaque was not performed on two of those subjects, giving an overall number of 25 subjects (64 implants) as basis for the 3-year presence of plaque analysis.

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

Outcome measures

Outcome measures
Measure	OsseoSpeed™ TX n=64 Implants OsseoSpeed™ TX implants of lengths 8-17 mm
Presence of Plaque	9 Implants

Adverse Events

OsseoSpeed™ TX

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	OsseoSpeed™ TX n=42 participants at risk OsseoSpeed™ TX implants of lengths 8-17 mm
Vascular disorders Paralytic stroke	2.4% 1/42 • Number of events 1 • 3 years
Renal and urinary disorders Adenocarcinoma of urinary bladder	2.4% 1/42 • Number of events 1 • 3 years
Musculoskeletal and connective tissue disorders Femur Neck Fracture	2.4% 1/42 • Number of events 1 • 3 years

Other adverse events

Other adverse events
Measure	OsseoSpeed™ TX n=42 participants at risk OsseoSpeed™ TX implants of lengths 8-17 mm
Musculoskeletal and connective tissue disorders Insufficient osseointegration of the implant during healing phase	16.7% 7/42 • Number of events 7 • 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