N/A
N=36
Study to Compare Marginal Bone Loss Around Implants From Two Dental Implant Systems.
Jaw, Edentulous, Partially
Bottom Line
View on ClinicalTrials.gov: NCT00746187 ↗Enrolled (actual)
36
Serious AEs
5.6%
Results posted
Apr 2014
Primary outcome: Primary: Marginal Bone Level Changes — -0.25; -0.50 millimeter
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm. (Device); 3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dentsply Sirona Implants and Consumables
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Marginal Bone Level Changes |
-0.25; -0.50 | — |
Summary
The purpose of this study is to compare marginal bone level changes between ASTRA TECH Implant System; Fixture ST and Biomet 3i; Osseotite® Implants. Subjects with partial edentulism in the posterior maxilla and/or mandible will be included and a one-stage surgical protocol will be used. Implants will be loaded within 15 weeks from installation. The subjects will be followed for 3 years.
Eligibility Criteria
Inclusion Criteria
- Provision of written informed consent
- Age 18 - 75 years
- Partial edentulism, Kennedy class I or II, last natural tooth must be cuspid or first bicuspid
- Edentulous in the area/s if implant placement for more than 2 months
Exclusion Criteria
- Untreated caries and/or periodontal disease of residual dentition
- Need for pre-surgical bone or soft tissue augmentation in the planned implant area/s.
- Absence of occlusal stability in centric occlusion
- Any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
- Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
- Pregnancy
- Present alcohol or drug abuse
- Tobacco smoking during the last 6 months
- Unable or unwilling to return for follow-up visits for a period of 3 years
Data sourced from ClinicalTrials.gov (NCT00746187). 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.