Clinical trial NCT00646113: 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
Overall status: COMPLETED
Phase: NA
Conditions: Jaw, Edentulous, Partially
Lead sponsor: Dentsply Sirona Implants and Consumables
Sponsor class: INDUSTRY
First posted: 2008-03-28
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Implant Survival Rate
timeFrame: Evaluated at implant placement and at the 5 years follow-up after implant placement
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Tand-mund-kaebekirurgisk Klinik
city: Ulm
country: Germany
facility: Bundeswehrkrankenhaus
city: Milano
country: Italy
facility: Clinica Odontoiatrica
city: Granada
country: Spain
facility: Department Oral Surgery, University of Granada: School of Dentistry
city: Jönköping
country: Sweden
facility: Käkkirurgiska kliniken, Odontologiska Institutionen
city: Bristol
country: United Kingdom
facility: Bristol Dental Hospital and School
Study officials:
affiliation: University of Granada: School of Dentistry
name: Pablo Galindo Moreno, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.