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

Not Applicable

Completed

• Conditions: Jaw, Edentulous, Partially
• Interventions: Device: OsseoSpeed™ TX 3.0S

• Registration Number: NCT00646113
• Lead Sponsor: Dentsply Sirona Implants and Consumables

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-25
• Study First Submitted QC: 2008-03-25
• Study First Posted: 2008-03-28
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Results First Submitted: 2019-02-11
• Results First Submitted QC: 2019-09-04
• Results First Posted: 2019-10-01
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-04
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OsseoSpeed™ TX 3.0S (Dental implant)	OsseoSpeed™ TX 3.0S	OsseoSpeed™ TX 3.0S, Dental implants, 3.0 mm diameter, in lengths of 11, 13 and 15 mm

Primary Outcome Measures

Name	Time	Method
Implant Survival Rate	Evaluated at implant placement and at the 5 years follow-up after implant placement	Overall implant survival rate evaluated clinically and radiographically

Trial Locations

Locations (6)

Department Oral Surgery, University of Granada: School of Dentistry; 🇪🇸 Granada, Spain

Bundeswehrkrankenhaus; 🇩🇪 Ulm, Germany

Tand-mund-kaebekirurgisk Klinik; 🇩🇰 Copenhagen, Denmark

Käkkirurgiska kliniken, Odontologiska Institutionen; 🇸🇪 Jönköping, Sweden

Clinica Odontoiatrica; 🇮🇹 Milano, Italy

Bristol Dental Hospital and School; 🇬🇧 Bristol, United Kingdom