N/A
N=45
Study on OsseoSpeed™ TX Implants in a Chinese Population
Partially Edentulous Jaw
Bottom Line
View on ClinicalTrials.gov: NCT01346683 ↗Enrolled (actual)
45
Serious AEs
2.2%
Results posted
May 2019
Primary outcome: Primary: Marginal Bone Level Alteration — 0.10 millimeter
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- OsseoSpeed TX (Device)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Dentsply Sirona Implants and Consumables
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Marginal Bone Level Alteration |
0.10 | — |
| SECONDARY Implant Survival |
92 | — |
| SECONDARY Implant Stability |
92 | — |
| SECONDARY Soft Tissue Status (PPD). |
-0.77 | — |
| SECONDARY Soft Tissue Status (BoP) |
30 | — |
Summary
To investigate the clinical efficacy of OsseoSpeed™ TX implants 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 posterior mandible is a safe and predictable procedure.
Eligibility Criteria
Inclusion criteria
- Provision of informed consent
- Aged 20-75 years at enrolment
- History of edentulism in the posterior mandible, Kennedy classes I or II, of at least four months. Last natural tooth in function is canine or first bicuspid.
- Neighboring tooth to the planned bridge must have natural root.
- Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge.
- Deemed by the investigator to have adequate bone height and a bone width of minimum 5.5 mm.
- 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
- Earlier graft procedures in the study area
- Current need for pre-surgical bone or soft tissue augmentation in the planned implant area.
- 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
- Uncontrolled diabetes mellitus
- Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
- Smoking more than 10 cigarettes/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 enrolment in the present study.
- Simultaneous participation in another clinical study or participation in a clinical study during the last 6 months.
- Subjects that are unable to give informed consent
Data sourced from ClinicalTrials.gov (NCT01346683). 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.