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

Primary Purpose

Jaw, Edentulous, Partially

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
OsseoSpeed™ TX 3.0S
Sponsored by
Dentsply Sirona Implants and Consumables
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Jaw, Edentulous, Partially

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tand-mund-kaebekirurgisk Klinik
  • Bundeswehrkrankenhaus
  • Clinica Odontoiatrica
  • Department Oral Surgery, University of Granada: School of Dentistry
  • Käkkirurgiska kliniken, Odontologiska Institutionen
  • Bristol Dental Hospital and School

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OsseoSpeed™ TX 3.0S (Dental implant)

Arm Description

OsseoSpeed™ TX 3.0S, Dental implants, 3.0 mm diameter, in lengths of 11, 13 and 15 mm

Outcomes

Primary Outcome Measures

Implant Survival Rate
Overall implant survival rate evaluated clinically and radiographically

Secondary Outcome Measures

Full Information

First Posted
March 25, 2008
Last Updated
November 4, 2019
Sponsor
Dentsply Sirona Implants and Consumables
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1. Study Identification

Unique Protocol Identification Number
NCT00646113
Brief Title
Study Evaluating OsseoSpeed™ Narrow Implant in the Upper and Lower Anterior Jaw
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 2008 (Actual)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dentsply Sirona Implants and Consumables

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw, Edentulous, Partially

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OsseoSpeed™ TX 3.0S (Dental implant)
Arm Type
Experimental
Arm Description
OsseoSpeed™ TX 3.0S, Dental implants, 3.0 mm diameter, in lengths of 11, 13 and 15 mm
Intervention Type
Device
Intervention Name(s)
OsseoSpeed™ TX 3.0S
Intervention Description
OsseoSpeed™ TX 3.0 mm diameter
Primary Outcome Measure Information:
Title
Implant Survival Rate
Description
Overall implant survival rate evaluated clinically and radiographically
Time Frame
Evaluated at implant placement and at the 5 years follow-up after implant placement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo Galindo Moreno, Assoc. Prof.
Organizational Affiliation
University of Granada: School of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tand-mund-kaebekirurgisk Klinik
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Bundeswehrkrankenhaus
City
Ulm
ZIP/Postal Code
D-89081
Country
Germany
Facility Name
Clinica Odontoiatrica
City
Milano
ZIP/Postal Code
20123
Country
Italy
Facility Name
Department Oral Surgery, University of Granada: School of Dentistry
City
Granada
ZIP/Postal Code
18071
Country
Spain
Facility Name
Käkkirurgiska kliniken, Odontologiska Institutionen
City
Jönköping
ZIP/Postal Code
551 11
Country
Sweden
Facility Name
Bristol Dental Hospital and School
City
Bristol
ZIP/Postal Code
BS1 2LY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22093047
Citation
Galindo-Moreno P, Nilsson P, King P, Becktor J, Speroni S, Schramm A, Maiorana C. Clinical and radiographic evaluation of early loaded narrow diameter implants - 1-year follow-up. Clin Oral Implants Res. 2012 May;23(5):609-16. doi: 10.1111/j.1600-0501.2011.02254.x. Epub 2011 Sep 28.
Results Reference
result
PubMed Identifier
25650268
Citation
Maiorana C, King P, Quaas S, Sondell K, Worsaae N, Galindo-Moreno P. Clinical and radiographic evaluation of early loaded narrow-diameter implants: 3 years follow-up. Clin Oral Implants Res. 2015;26(1):77-82. doi: 10.1111/clr.12281. Epub 2013 Oct 30.
Results Reference
result
PubMed Identifier
26929953
Citation
King P, Maiorana C, Luthardt RG, Sondell K, Oland J, Galindo-Moreno P, Nilsson P. Clinical and Radiographic Evaluation of a Small-Diameter Dental Implant Used for the Restoration of Patients with Permanent Tooth Agenesis (Hypodontia) in the Maxillary Lateral Incisor and Mandibular Incisor Regions: A 36-Month Follow-Up. Int J Prosthodont. 2016 Mar-Apr;29(2):147-53. doi: 10.11607/ijp.4444.
Results Reference
result
PubMed Identifier
28626888
Citation
Galindo-Moreno P, Nilsson P, King P, Worsaae N, Schramm A, Padial-Molina M, Maiorana C. Clinical and radiographic evaluation of early loaded narrow-diameter implants: 5-year follow-up of a multicenter prospective clinical study. Clin Oral Implants Res. 2017 Dec;28(12):1584-1591. doi: 10.1111/clr.13029. Epub 2017 Jun 18.
Results Reference
result

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

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