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

An Open, Prospective, Multi-center Study to Evaluate OsseoSpeed™ TX Single Implant 3 mm Diameter in the Anterior Mandible. A 3-years Follow-up Study.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01473355

Enrollment

Registered

2011-11-17

Start date

2011-10-31

Completion date

2016-10-31

Last updated

2019-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Partially Edentulous Jaw

Brief summary

The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX 3mm diameter implant in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior mandible up to 3 years after loading. Hypothesis: Early loading of the 3 mm implant is a safe and predictable procedure.

Interventions

DEVICEOsseoSpeed™ TX

OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Provision of informed consent 2. Aged 20-75 years at enrolment 3. History of edentulism in the study area of at least two months 4. Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crowns 5. Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant 6. Deemed by the investigator as likely to present an initially stable implant situation

Exclusion criteria

1. Unlikely to be able to comply with study procedures, as judged by the investigator 2. Uncontrolled pathologic processes in the oral cavity 3. Known or suspected current malignancy 4. History of radiation therapy in the head and neck region 5. History of chemotherapy within 5 years prior to surgery 6. Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration, as deemed by the investigator 7. Uncontrolled diabetes mellitus 8. Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration 9. Smoking more than 10 cigarettes per day 10. Present alcohol and/or drug abuse 11. Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site) 12. Previous enrollment in the present study 13. Simultaneous participation in another clinical study, or participation in a clinical study during the last weeks prior to enrollment

Design outcomes

Primary

Measure	Time frame	Description
Number of Survived Implants	Measured at the 3 year follow-up after implant loading.	Implant survival rate evaluated by clinically and radiographically counting the number of implants remaining in function

Secondary

Measure	Time frame	Description
Marginal Bone Level Alteration	Measured at the 3 year follow-up after implant loading.	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).
Number of Stable Implants	Measured at the 3 year follow-up after implant loading.	Implant stability evaluated clinically/manually (recorded as stable yes/no).
Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD	Measured at the 3 year follow-up after implant loading.	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.
Evaluation of the Periimplant Mucosa Condition - By Assessment of BoP	Measured at the 3 year follow-up after implant loading.	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.
Presence of Plaque	Measured at the 3 year follow-up after implant loading.	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.

Countries

China

Participant flow

Participants by arm

Arm	Count
OsseoSpeed™ TX OsseoSpeed™ TX narrow implants (diameter 3 mm) in lengths of 11-15 mm	45
OsseoSpeed™ TX OsseoSpeed™ TX narrow implants (diameter 3 mm) in lengths of 11-15 mm	75
Total	120

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	2
Overall Study	Lost to Follow-up	2
Overall Study	Protocol Violation	2

Baseline characteristics

Characteristic	OsseoSpeed™ TX
Age, Continuous	52.5 years STANDARD_DEVIATION 11.86
Region of Enrollment China	45 participants
Sex: Female, Male Female	12 Participants
Sex: Female, Male Male	33 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 45
serious Total, serious adverse events	2 / 45

Outcome results

Primary

Number of Survived Implants

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