Study Evaluating OsseoSpeed™ Narrow Implant in the Upper and Lower Anterior Jaw

November 4, 2019 updated by: Dentsply Sirona Implants and Consumables

An Open, Prospective, Single Arm, Multi-centre Study Evaluating OsseoSpeed™ Implant 3 mm Diameter Replacing a Central or Lateral Mandibular Incisor or Lateral Maxillary Incisor. A 5-year Follow-up Study.

To evaluate 5-year survival, functionality and safety for OsseoSpeed™ 3.0 mm diameter implant when used for single tooth crown in positions 12, 22, 31, 32, 41 and 42. The primary hypothesis is that implant survival after 5 years is equal to what has been observed with comparable implants in current literature.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Tand-mund-kaebekirurgisk Klinik
  • Germany
      • Ulm, Germany, D-89081
        • Bundeswehrkrankenhaus
  • Italy
      • Milano, Italy, 20123
        • Clinica Odontoiatrica
  • Spain
      • Granada, Spain, 18071
        • Department Oral Surgery, University of Granada: School of Dentistry
  • Sweden
      • Jönköping, Sweden, 551 11
        • Käkkirurgiska kliniken, Odontologiska Institutionen
  • United Kingdom
      • Bristol, United Kingdom, BS1 2LY
        • Bristol Dental Hospital and School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provision of informed consent
  • Aged 18-70 years at enrolment
  • History of edentulism in the study area of at least two months
  • Presence of natural tooth roots adjacent to the study implant position
  • Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant
  • 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
  • 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, as deemed by the investigator
  • Uncontrolled diabetes mellitus
  • Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
  • Smoking more than 10 cigarettes per day
  • 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, or participation in a clinical study during the last weeks prior to enrolment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OsseoSpeed™ TX 3.0S (Dental implant)
OsseoSpeed™ TX 3.0S, Dental implants, 3.0 mm diameter, in lengths of 11, 13 and 15 mm
Device: OsseoSpeed™ TX 3.0S
OsseoSpeed™ TX 3.0 mm diameter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Survival Rate
Time Frame: Evaluated at implant placement and at the 5 years follow-up after implant placement
Overall implant survival rate evaluated clinically and radiographically
Evaluated at implant placement and at the 5 years follow-up after implant placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dentsply Sirona Implants and Consumables

Investigators

  • Principal Investigator: Pablo Galindo Moreno, Assoc. Prof., University of Granada: School of Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2008

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

March 25, 2008

First Submitted That Met QC Criteria

March 25, 2008

First Posted (Estimate)

March 28, 2008

Study Record Updates

Last Update Posted (Actual)

November 18, 2019

Last Update Submitted That Met QC Criteria

November 4, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YA-NAR-0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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