Study Evaluating OsseoSpeed™ Narrow Implant in the Upper and Lower Anterior Jaw
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.
1 other identifier
interventional
72
6 countries
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2008
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 25, 2008
CompletedFirst Posted
Study publicly available on registry
March 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
October 1, 2019
CompletedNovember 18, 2019
November 1, 2019
6.4 years
March 25, 2008
February 11, 2019
November 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Implant Survival Rate
Overall implant survival rate evaluated clinically and radiographically
Evaluated at implant placement and at the 5 years follow-up after implant placement
Study Arms (1)
OsseoSpeed™ TX 3.0S (Dental implant)
EXPERIMENTALOsseoSpeed™ TX 3.0S, Dental implants, 3.0 mm diameter, in lengths of 11, 13 and 15 mm
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Tand-mund-kaebekirurgisk Klinik
Copenhagen, 2100, Denmark
Bundeswehrkrankenhaus
Ulm, D-89081, Germany
Clinica Odontoiatrica
Milan, 20123, Italy
Department Oral Surgery, University of Granada: School of Dentistry
Granada, 18071, Spain
Käkkirurgiska kliniken, Odontologiska Institutionen
Jönköping, 551 11, Sweden
Bristol Dental Hospital and School
Bristol, BS1 2LY, United Kingdom
Related Publications (4)
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.
PMID: 22093047RESULTMaiorana 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.
PMID: 25650268RESULTKing 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.
PMID: 26929953RESULTGalindo-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.
PMID: 28626888RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Manager Global Clinical Research
- Organization
- Dentsply Sirona Implants, Mölndal, SWEDEN
Study Officials
- PRINCIPAL INVESTIGATOR
Pablo Galindo Moreno, Assoc. Prof.
University of Granada: School of Dentistry
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2008
First Posted
March 28, 2008
Study Start
March 1, 2008
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
November 18, 2019
Results First Posted
October 1, 2019
Record last verified: 2019-11