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Clinical Trials/NCT01340170
NCT01340170CompletedNot Applicable

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

Dentsply Sirona Implants and Consumables16 sites in 1 country168 target enrollmentStarted: April 1, 2011Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
168
Locations
16
Primary Endpoint
Marginal Bone Level Change
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

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)

Investigators

Sponsor
Dentsply Sirona Implants and Consumables
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (16)

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