N/A
N=95
Study Comparing OsseoSpeed™ Implants of Two Different Lengths in the Upper and Lower Posterior Jaw
Jaw, Edentulous, Partially
Bottom Line
View on ClinicalTrials.gov: NCT00545818 ↗Enrolled (actual)
95
Serious AEs
13.7%
Results posted
May 2020
Primary outcome: Primary: Radiological Assessments of Marginal Bone Level Alteration — 0.02; -0.18 millimeter
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- OsseoSpeed™ length 6 mm (Device); OsseoSpeed™ length 11 mm (Device)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Dentsply Sirona Implants and Consumables
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radiological Assessments of Marginal Bone Level Alteration |
0.02; -0.18 | — |
| SECONDARY Overall Implant Survival |
101; 100 | — |
| SECONDARY Evaluation of the Periimplant Mucosa Condition - By Assessment BoP |
43; 28 | — |
| SECONDARY Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in PPD |
-0.57; -1.11 | — |
| SECONDARY Presence of Plaque |
16; 6 | — |
Summary
The purpose of this study is to see if OsseoSpeed™ implant 6 mm long is effective for rehabilitation of edentulism and if so, how it compares with OsseoSpeed™ implant 11 mm long. The primary hypothesis is that the alteration in bone level is equal in patients randomized to 6 mm as to patients randomized to 11 mm implants.
Eligibility Criteria
Inclusion Criteria
- Provision of informed consent
- Aged 20-70 years at enrolment
- History of edentulism in the study area of at least four months
- Neighboring tooth/teeth to the planned bridge must have natural root(s)
- 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 a bone height of at least 11 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.
- Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
- Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months
Data sourced from ClinicalTrials.gov (NCT00545818). 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.