N/A
Completed N=45
Study on OsseoSpeed™ TX Narrow Implants in the Lower Jaw in a Chinese Population
Partially Edentulous Jaw
Source: ClinicalTrials.gov NCT01473355 ↗
Enrolled (actual)
45
Serious AEs
4.4%
Results posted
Oct 2019
Primary outcomePrimary: Number of Survived Implants — 74 Implants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Survived Implants |
74 | — |
| SECONDARY Marginal Bone Level Alteration |
-0.02 | — |
| SECONDARY Number of Stable Implants |
65 | — |
| SECONDARY Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD |
-0.03 | — |
| SECONDARY Evaluation of the Periimplant Mucosa Condition - By Assessment of BoP |
33 | — |
| SECONDARY Presence of Plaque |
49 | — |
Eligibility Criteria
Inclusion criteria
- Provision of informed consent
- Aged 20-75 years at enrolment
- History of edentulism in the study area of at least two months
- Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crowns
- Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant
- Deemed by the investigator as likely to present an initially stable implant situation
Exclusion Criteria
- Unlikely to be able to comply with study procedures, as judged by the investigator
- Uncontrolled pathologic processes in the oral cavity
- Known or suspected current malignancy
- History of radiation therapy in the head and neck region
- History of chemotherapy within 5 years prior to surgery
- Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration, as deemed by the investigator
- Uncontrolled diabetes mellitus
- Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
- Smoking more than 10 cigarettes per day
- Present alcohol and/or drug abuse
- Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
- Previous enrollment in the present study
- Simultaneous participation in another clinical study, or participation in a clinical study during the last weeks prior to enrollment
Data sourced from ClinicalTrials.gov (NCT01473355). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.