N/A
N=45
Study on OsseoSpeed™ TX Short Implants in a Chinese Population
Partially Edentulous Jaw
Bottom Line
View on ClinicalTrials.gov: NCT01346696 ↗Enrolled (actual)
45
Serious AEs
6.7%
Results posted
May 2019
Primary outcome: Primary: Marginal Bone Level Alteration — -0.06 millimeter
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- OsseoSpeed™ TX implant (Ø 4.0 mm, length 6 mm) (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 |
-0.06 | — |
| SECONDARY Marginal Bone Level Alteration After 36 Months |
0.07 | — |
| SECONDARY Implant Survival |
75 | — |
| SECONDARY Implant Stability |
75 | — |
| SECONDARY Condition of the Periimplant Mucosa (PPD). |
-0.63 | — |
| SECONDARY Condition of the Periimplant Mucosa (BoP). |
43 | — |
| SECONDARY Plaque |
29 | — |
| SECONDARY Crown-to-implant Ratio |
1.70 | — |
Summary
The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX 6 mm implants in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior mandible and maxilla up to 3 years after loading. The hypothesis is that one stage surgery using 6 mm OsseoSpeed™ TX implant in the posterior region is safe and predictable.
Eligibility Criteria
Inclusion criteria
- Provision of informed consent
- Female and male aged 20-75 years at enrolment
- In need for 2-3 implants in either side of the posterior mandible or maxilla (premolar and molar region)
- History of edentulism in the study area of at least four months
- Neighboring tooth/teeth to the planned bridge/crowns must have natural root(s)
- Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge/crowns
- Deemed by the investigator to be suitable for implants of 6 mm length and to have a bone height of at least 6 mm and a bone width of minimum 6 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
- 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 (NCT01346696). 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.