Trial Outcomes & Findings for Study on OsseoSpeed™ TX Short Implants in a Chinese Population (NCT NCT01346696)

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, and expressed in millimeters. Marginal Bone Level change calculated from values obtained at delivery of permanent restoration i.e. loading of implants (baseline) compared to the values obtained at the follow-up visit 12 months after loading. Positive value = bone gain, Negative values = bone loss.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

45 participants

Primary outcome timeframe

Evaluated from implant installation to 12 months after implant loading

Results posted on

2019-10-08

Participant Flow

Unit of analysis: Implants

Participant milestones

Participant milestones
Measure	OsseoSpeed™ TX Implants OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm.
Overall Study STARTED	45 94
Overall Study COMPLETED	44 90
Overall Study NOT COMPLETED	1 4

Reasons for withdrawal

Reasons for withdrawal
Measure	OsseoSpeed™ TX Implants OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm.
Overall Study Death	1

Baseline Characteristics

Study on OsseoSpeed™ TX Short Implants in a Chinese Population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OsseoSpeed™ TX Implants n=94 Implants OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm.
Age, Continuous	52.9 years STANDARD_DEVIATION 10.61 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment China	45 participants n=5 Participants

PRIMARY outcome

Timeframe: Evaluated from implant installation to 12 months after implant loading

Population: 45 subjects (90 implants) completed the 12-month follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 36 subjects (75 implants). Six of the collected radiographs were not possible to evaluate, giving an overall number of 35 subjects (69 implants) as basis for the 12 months analysis of MBL change.

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, and expressed in millimeters. Marginal Bone Level change calculated from values obtained at delivery of permanent restoration i.e. loading of implants (baseline) compared to the values obtained at the follow-up visit 12 months after loading. Positive value = bone gain, Negative values = bone loss.

Outcome measures

Outcome measures
Measure	OsseoSpeed™ TX Implants n=69 Implants OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm.
Marginal Bone Level Alteration	-0.06 millimeter Standard Deviation 0.55

SECONDARY outcome

Timeframe: Evaluated from implant loading to 36 months after implant loading.

Population: 44 subjects (90 implants) completed the 36-month follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 36 subjects (75 implants). Four of the collected radiographs were not possible to evaluate, giving an overall number of 35 subjects (71 implants) as basis for the 36 months analysis.

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, and expressed in millimeters. Marginal Bone Level change calculated from values obtained at delivery of permanent restoration i.e. loading of implants (baseline) compared to the values obtained at the follow-up visit 36 months after loading. Positive value = bone gain, Negative values = bone loss.

Outcome measures

Outcome measures
Measure	OsseoSpeed™ TX Implants n=35 Participants OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm.
Marginal Bone Level Alteration After 36 Months	0.07 millimeter Standard Deviation 0.49

SECONDARY outcome

Timeframe: Evaluated from implant installation to 36 months after implant loading.

Population: 44 subjects (90 implants) completed the 36-month follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 36 subjects (75 implants).

Implant survival rate evaluated clinically and radiographically.

Outcome measures

Outcome measures
Measure	OsseoSpeed™ TX Implants n=75 Implants OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm.
Implant Survival	75 Implants

SECONDARY outcome

Timeframe: Evaluated 36 months after implant loading.

Population: 44 subjects (90 implants) completed the 36-month follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 36 subjects (75 implants).

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

Outcome measures

Outcome measures
Measure	OsseoSpeed™ TX Implants n=75 Implants OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm.
Implant Stability	75 Implants

SECONDARY outcome

Timeframe: Evaluated from implant loading to 36 months after implant loading.

Population: 44 subjects (90 implants) completed the 36-month follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 36 subjects (75 implants). Baseline and/or follow-up measurements not available for 3 implants, giving an overall number of 36 subjects (72 implants) as basis for the 36 months analysis of PPD change.

Condition of the periimplant mucosa measured by assessment of probing pocket depth (PPD). Change in pocket depth expressed in millimeters at the 36 month 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 Implants n=72 Implants OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm.
Condition of the Periimplant Mucosa (PPD).	-0.63 millimeter Standard Deviation 0.83

SECONDARY outcome

Timeframe: Evaluated from implant loading to 36 months after implant loading.

Population: 44 subjects (90 implants) completed the 36-month follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 36 subjects (75 implants). The BoP measurement was not completed for one implant, giving an overall number of 36 subjects (74 implants) as basis for the 36 months analysis of BoP.

Condition of the periimplant mucosa will be measured by assessment of bleeding on probing (BoP). Presented as % of the implants that show presence of bleeding at time of the 36 months follow-up.

Outcome measures

Outcome measures
Measure	OsseoSpeed™ TX Implants n=74 Implants OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm.
Condition of the Periimplant Mucosa (BoP).	43 Implants

SECONDARY outcome

Timeframe: Evaluated 36 months after implant loading.

Population: 44 subjects (90 implants) completed the 36-month follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 36 subjects (75 implants). Plaque measurement was not completed for one implant, giving an overall number of 36 subjects (74 implants) as basis for the 36 months analysis of Plaque.

Occurence of plaque around the study implant. Presented as proportion of implants that showed presence of plaque at the 36 months follow-up visit.

Outcome measures

Outcome measures
Measure	OsseoSpeed™ TX Implants n=74 Implants OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm.
Plaque	29 Implants

SECONDARY outcome

Timeframe: 12 months after implant loading

Population: 45 subjects (90 implants) completed the 12-month follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 36 subjects (75 implants). 6 of the collected radiographs were not possible to evaluate, giving an overall number of 35 subjects (68 implants) as basis for 12 months analysis of Crown-to-implant ratio.

Crown height measured radiographically from the implant-abutment interface to the most coronal point on the prosthesis. The crown-to-implant ratio calculated from radiographs

Outcome measures

Outcome measures
Measure	OsseoSpeed™ TX Implants n=68 Implants OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm.
Crown-to-implant Ratio	1.70 Ratio Standard Deviation 0.32

Adverse Events

OsseoSpeed™ TX Implants

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	OsseoSpeed™ TX Implants n=45 participants at risk OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm.
Musculoskeletal and connective tissue disorders Right femoral neck fracture	2.2% 1/45 • Number of events 1 • 3 years
Hepatobiliary disorders Hepatic hilum cholangiocarcinoma	2.2% 1/45 • Number of events 1 • 3 years
Eye disorders Cataract	2.2% 1/45 • Number of events 1 • 3 years

Other adverse events

Other adverse events
Measure	OsseoSpeed™ TX Implants n=45 participants at risk OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm.
Investigations Study implant not stable - implant lost	8.9% 4/45 • Number of events 4 • 3 years
Investigations Study implant not stable - extended healing time	6.7% 3/45 • Number of events 3 • 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