N/A
N=101
Short Implants - An Alternative to Bone Grafting?
Jaw, Edentulous, Partially
Bottom Line
View on ClinicalTrials.gov: NCT01030523 ↗Enrolled (actual)
101
Serious AEs
12.9%
Results posted
Sep 2020
Primary outcome: Primary: Implant Survival Rate — 66; 70 Implants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm) (Device); ASTRA TECH Implant System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm) in combination with bone grafting (Device)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Dentsply Sirona Implants and Consumables
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Implant Survival Rate |
66; 70 | — |
| SECONDARY Average Marginal Bone Level (MBL) Change From Permanent Restoration on Implant Level |
-0.12; -0.24 | — |
| SECONDARY Average Marginal Bone Level (MBL) Change From Permanent Restoration on Implant Level |
-0.12; -0.24 | — |
| SECONDARY Condition of Periimplant Mucosa Measured Through Bleeding on Probing (BoP) |
16; 23 | — |
| SECONDARY Condition of Periimplant Mucosa Measured Through Bleeding on Probing (BoP) |
16; 23 | — |
| SECONDARY Condition of Periimplant Mucosa Measure by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration |
-0.4; -0.7 | — |
| SECONDARY Condition of Periimplant Mucosa Measure by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration |
-0.4; -0.7 | — |
| SECONDARY Change in Overall Oral Health Impact Profile (OHIP-49) |
-2.2; -9.8 | — |
| SECONDARY Change in Overall Oral Health Impact Profile (OHIP-49) |
-2.2; -9.8 | — |
Summary
The study, with the ASTRA TECH Implant System, is comparing short implants (OsseoSpeed™) to standard length implants (OsseoSpeed™) in combination with bone grafting. The hypothesis is that the use of short implants in posterior maxilla with inadequate bone is as safe and predictable as placing standard length implants in combination with bone augmentation.
Eligibility Criteria
Inclusion Criteria
- Provision of informed consent
- Aged 20-75 years at enrolment
- History of edentulism in the study area of at least four months
- In need for 1-4 implants in either side of the posterior maxilla (premolar and molar region)
- Neighboring tooth/teeth to the planned implant/s must have natural root(s) or implant supported restoration, with absence of pathology or excessive bone loss, as judged by the investigator
- Presence of natural tooth/teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crown/s
- Deemed by the investigator to have a bone height between 5 and 7 mm and a bone width of a minimum of 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 bone 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, iv bisphosphonates or any other medication that could influence post-operative healing and/or osseointegration
- Smoking more than 10 cigarettes/day
- Bruxism
- 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
Data sourced from ClinicalTrials.gov (NCT01030523). 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.