N/A
N=168
A Study Evaluating OsseoSpeed TX Using Different Drilling Protocols With Immediate Loading
Edentulism
Bottom Line
View on ClinicalTrials.gov: NCT01340170 ↗Enrolled (actual)
168
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Marginal Bone Level Change — -0.25; -0.2 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- OsseoSpeed TX (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dentsply Sirona Implants and Consumables
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Marginal Bone Level Change |
-0.2; -0.29 | — |
| SECONDARY Marginal Bone Level Change |
-0.2; -0.29 | — |
| SECONDARY Implant Survival Rate |
82; 94; 2; 4 | — |
| SECONDARY Implant Stability Assessed Clinically/Manually |
86; 97; 0; 5 | — |
| SECONDARY Implant Stability Using Resonance Frequency Analysis (RFA) |
78.6; 77.5; 78.8; 77.7 | — |
| SECONDARY Perception During Implant Insertion - "The Implant Was Guided Into the Prepared Osteotomy" |
7.5; 7.1 | — |
| SECONDARY Perception During Implant Insertion - "The Implant Followed the Prepared Osteotomy" |
8.2; 7.6 | — |
| SECONDARY Perception During Implant Insertion - "The Implant Has a Good Primary Stability" |
8.7; 8.1 | — |
Summary
This study is initiated to support the OsseoSpeedTM TX implant with clinical data showing that a soft bone drilling protocol and immediate loading does not have any important negative effect on marginal bone level maintenance.
Eligibility Criteria
Inclusion Criteria
- Provision of informed consent
- Female/male aged 18 years and over
- History of edentulism in the study area of at least 3 months
- At least 4 months healing after last grafting procedure in the study area
- In need for implant treatment replacing one to four missing single tooth in positions 14-17, 24-27, 34-37 and 44-47
- The study implant position must be surrounded by natural tooth roots, unless the implant will constitute the most distal dentition.
- Deemed by the investigator to be suitable for one stage surgery
- Deemed by the investigator to be suitable for immediate loading
- Deemed by the investigator as likely to present an initially stable implant situation.
- Deemed by the investigator to have a "functional" opposing dentition at the time of loading the implants.
Exclusion Criteria
- Unlikely to be able to comply with study procedures, as judged by the investigator
- Uncontrolled pathological 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 would compromise post-operative healing and/or osseointegration
- Uncontrolled diabetes mellitus
- Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
- Present alcohol and/or drug abuse
- Current need for bone grafting and/or augmentation in the planned implant area
- 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.
Data sourced from ClinicalTrials.gov (NCT01340170). 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.