Clinical trial NCT01324778: Multi Centre Study Comparing OsseoSpeed TX With OsseoSpeed
Official title: An Open, Randomized, Prospective Multi Centre Study Comparing OsseoSpeedTM TX With OsseoSpeedTM in the Partially and Totally Edentulous Maxillae
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Partial Edentulism
Edentulism Nos
Keywords: Edentulism in the Upper Jaw
Lead sponsor: Dentsply Sirona Implants and Consumables
Sponsor class: INDUSTRY
First posted: 2011-03-29
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare marginal bone level alterations, implant stability and implant survival between OsseoSpeed och OsseoSpeed TX


Eligibility criteria: Inclusion Criteria:

1. Provision of informed consent
2. Female/male aged 18 years and over
3. History of edentulism in the study area of at least 3 months
4. In need for implant(s) replacing missing tooth/teeth in the maxilla
5. Deemed by the investigator to be suitable for one stage surgery
6. Deemed by the investigator to be suitable for loading after 10-12 weeks
7. Deemed by the investigator as likely to present an initially stable implant situation.
8. Deemed by the investigator to have a "functional" opposing dentition at the time of loading the implants.

Exclusion criteria:

1. Unlikely to be able to comply with study procedures, as judged by the investigator
2. Uncontrolled pathological processes in the oral cavity
3. Known or suspected current malignancy
4. History of radiation therapy in the head and neck region
5. History of chemotherapy within 5 years prior to surgery
6. Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
7. Uncontrolled diabetes mellitus
8. Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
9. Present alcohol and/or drug abuse
10. Current need for bone grafting and/or augmentation in the planned implant area
11. Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
12. Previous enrolment in the present study.
13. Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months.

Primary outcomes:
measure: Marginal Bone Level
timeFrame: One year after loading
Secondary outcomes:
measure: Implant stability
timeFrame: At implant placement (inclusion) (day 1)
measure: Implant stability
timeFrame: At implant placement (inclusion) (day 1)
measure: Implant stability
timeFrame: At implant loading (10-12 weeks after implant placement)
measure: Implant survival
timeFrame: One year after loading
Other outcomes:
Locations:
city: Halmstad
country: Sweden
facility: Specialisttandvården, Hallands sjukhus
city: Jönköping
country: Sweden
facility: Avd. för Parodontologi / Avd. för Oral Protetik, Odontologiska Institutionen
city: Kalmar
country: Sweden
facility: Specialist- och sjukhustandvården
city: Linköping
country: Sweden
facility: Centrum för Oral Rehablilitering
city: Mölndal
country: Sweden
facility: Colossseumkliniken Mölndal
city: Stockholm
country: Sweden
facility: Käkcentrum, Södersjukhuset
city: Stockholm
country: Sweden
facility: Specialisttandvården, S:t Eriks Sjukhus
city: Trollhättan
country: Sweden
facility: Käkkirurgiska kliniken NÄL / Specialistcentrum Uddevalla sjukhus
city: Umeå
country: Sweden
facility: Käkkirurgiska Kliniken/Protetikkliniken
city: Växjö
country: Sweden
facility: Parodontologi kliniken och Protetik- och Bettfysiologiska kliniken
city: Örebro
country: Sweden
facility: Käkkirurgiska kliniken / Protetikkliniken
Study officials:
affiliation: Colosseumkliniken Mölndal
name: Carl-Johan Ivanoff, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ivanoff CJ, Lindhe J, Ellner S, Johansson KJ, Abrahamsson P. An open, randomised, multi-centre study, comparing straight and tapered apex implants design, in partially and totally edentulous maxillae. Acta Odontol Scand. 2021 Oct;79(7):492-498. doi: 10.1080/00016357.2021.1894352. Epub 2021 Mar 5.