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

Jaw, Edentulous, Partially Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00646113
• Other study ID #: YA-NAR-0001
• Status: Completed
• Phase: N/A
• Start date: March 2008
• Est. completion date: August 2014

Study information

• Verified date: November 2019
• Source: Dentsply Sirona Implants
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Jaw, Edentulous
• Jaw, Edentulous, Partially

Intervention

Device:
• OsseoSpeed™ TX 3.0S
OsseoSpeed™ TX 3.0 mm diameter

Locations

Country	Name	City	State
Denmark	Tand-mund-kaebekirurgisk Klinik	Copenhagen
Germany	Bundeswehrkrankenhaus	Ulm
Italy	Clinica Odontoiatrica	Milano
Spain	Department Oral Surgery, University of Granada: School of Dentistry	Granada
Sweden	Käkkirurgiska kliniken, Odontologiska Institutionen	Jönköping
United Kingdom	Bristol Dental Hospital and School	Bristol

Sponsors (1)

Lead Sponsor	Collaborator
Dentsply Sirona Implants

Countries where clinical trial is conducted

Denmark,  Germany,  Italy,  Spain,  Sweden,  United Kingdom, 

References & 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.1600-0501.201 — View 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. 20 — View Citation

King P, Maiorana C, Luthardt RG, Sondell K, Øland 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 Late — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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