An Open, Non-randomized, Prospective Multi-centre Study Evaluating a Soft Bone Drilling Protocol for Single Tooth Restoration in the Posterior Area With Immediate Loading
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Edentulism
- Sponsor
- Dentsply Sirona Implants and Consumables
- Enrollment
- 168
- Locations
- 8
- Primary Endpoint
- Marginal Bone Level Change
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Detailed Description
This study is designed to evaluate a soft bone drilling protocol compared to a standard bone drilling protocol when using OsseoSpeedTM TX with regards to marginal bone level changes and implant survival rate one year after loading. The aim is also to investigate potential differences in initial stability and in general user friendliness between the two drilling protocols.
Investigators
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
- Not provided
Outcomes
Primary Outcomes
Marginal Bone Level Change
Time Frame: Implant insertion and 12 months post implant insertion
Marginal Bone Level alterations will be determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant.
Secondary Outcomes
- Marginal Bone Level Change(Implant insertion and 3 months post implant insertion)
- Implant Survival Rate(12 months after baseline, i.e., implant insertion)
- Implant Stability Assessed Clinically/Manually(At implant insertion)
- Implant Stability Using Resonance Frequency Analysis (RFA)(At implant insertion.)
- Perception During Implant Insertion - "The Implant Was Guided Into the Prepared Osteotomy"(After implant insertion)
- Perception During Implant Insertion - "The Implant Followed the Prepared Osteotomy"(After implant insertion)
- Perception During Implant Insertion - "The Implant Has a Good Primary Stability"(After implant insertion)