NCT01324778

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

Status
completed

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, 2011

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 29, 2011

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 10, 2017

Status Verified

May 1, 2017

Enrollment Period

5.8 years

First QC Date

March 22, 2011

Last Update Submit

May 9, 2017

Conditions

Partial EdentulismEdentulism Nos

Keywords

Edentulism in the Upper Jaw

Outcome Measures

Primary Outcomes (1)

  • Marginal Bone Level

    Marginal Bone Level will be determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal Bone Level expressed in millimeters at the 12 months follow-up visit will be compared to values obtained at delivery of permanent restoration i.e. loading (baseline).

    One year after loading

Secondary Outcomes (4)

  • Implant stability

    At implant placement (inclusion) (day 1)

  • Implant stability

    At implant placement (inclusion) (day 1)

  • Implant stability

    At implant loading (10-12 weeks after implant placement)

  • Implant survival

    One year after loading

Study Arms (2)

A

EXPERIMENTAL
Device: OsseoSpeed TX

B

ACTIVE COMPARATOR
Device: OsseoSpeed

Interventions

OsseoSpeed TXDEVICE

OsseoSpeedTM TX implants of lengths 6-17 mm

A
OsseoSpeedDEVICE

OsseoSpeedTM implants of lengths 6-17 mm

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Unlikely to be able to comply with study procedures, as judged by the investigator
  • Uncontrolled pathological 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 would compromise post-operative healing and/or osseointegration
  • Uncontrolled diabetes mellitus
  • Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
  • Present alcohol and/or drug abuse
  • Current need for bone grafting and/or augmentation in the planned implant area
  • 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 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Specialisttandvården, Hallands sjukhus

Halmstad, Sweden

Location

Avd. för Parodontologi / Avd. för Oral Protetik, Odontologiska Institutionen

Jönköping, Sweden

Location

Specialist- och sjukhustandvården

Kalmar, Sweden

Location

Centrum för Oral Rehablilitering

Linköping, 581 85, Sweden

Location

Colossseumkliniken Mölndal

Mölndal, 431 30, Sweden

Location

Käkkirurgiska kliniken / Protetikkliniken

Örebro, 701 85, Sweden

Location

Käkcentrum, Södersjukhuset

Stockholm, 118 83, Sweden

Location

Specialisttandvården, S:t Eriks Sjukhus

Stockholm, Sweden

Location

Käkkirurgiska kliniken NÄL / Specialistcentrum Uddevalla sjukhus

Trollhättan, 431 85, Sweden

Location

Käkkirurgiska Kliniken/Protetikkliniken

Umeå, 901 87, Sweden

Location

Parodontologi kliniken och Protetik- och Bettfysiologiska kliniken

Vaxjo, 352 31, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 33666125DERIVED

Study Officials

  • Carl-Johan Ivanoff, DDS, PhD

    Colosseumkliniken Mölndal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2011

First Posted

March 29, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

May 10, 2017

Record last verified: 2017-05

Locations

SE(11)