Multi Centre Study Comparing OsseoSpeed TX With OsseoSpeed

An Open, Randomized, Prospective Multi Centre Study Comparing OsseoSpeedTM TX With OsseoSpeedTM in the Partially and Totally Edentulous Maxillae

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

Study Overview

• Status: Completed
• Conditions: Partial Edentulism; Edentulism Nos
• Intervention / Treatment: Device: OsseoSpeed TX; Device: OsseoSpeed

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Halmstad, Sweden
    • Specialisttandvården, Hallands sjukhus
  • Jönköping, Sweden
    • Avd. för Parodontologi / Avd. för Oral Protetik, Odontologiska Institutionen
  • Kalmar, Sweden
    • Specialist- och sjukhustandvården
  • Linköping, Sweden, 581 85
    • Centrum för Oral Rehablilitering
  • Mölndal, Sweden, 431 30
    • Colossseumkliniken Mölndal
  • Stockholm, Sweden, 118 83
    • Käkcentrum, Södersjukhuset
  • Stockholm, Sweden
    • Specialisttandvården, S:t Eriks Sjukhus
  • Trollhättan, Sweden, 431 85
    • Käkkirurgiska kliniken NÄL / Specialistcentrum Uddevalla sjukhus
  • Umeå, Sweden, 901 87
    • Käkkirurgiska Kliniken/Protetikkliniken
  • Växjö, Sweden, 352 31
    • Parodontologi kliniken och Protetik- och Bettfysiologiska kliniken
  • Örebro, Sweden, 701 85
    • Käkkirurgiska kliniken / Protetikkliniken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: B	Device: OsseoSpeed; OsseoSpeedTM implants of lengths 6-17 mm
Experimental: A	Device: OsseoSpeed TX; OsseoSpeedTM TX implants of lengths 6-17 mm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant stability	Implant stability will be evaluated clinically/manually (recorded as stable yes/no)	At implant placement (inclusion) (day 1)
Implant stability	Implant stability will be evaluated using Resonance Frequency Analysis (RFA)	At implant placement (inclusion) (day 1)
Implant stability	Implant stability will be evaluated clinically/manually (recorded as stable yes/no)	At implant loading (10-12 weeks after implant placement)
Implant survival	Implant survival rate will be evaluated by clinically and radiographically counting the number of remaining implants from implant placement to one year after loading.	One year after loading

Collaborators and Investigators

• Sponsor: Dentsply Sirona Implants and Consumables
• Investigators: Principal Investigator: Carl-Johan Ivanoff, DDS, PhD, Colosseumkliniken Mölndal

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: March 22, 2011
• First Submitted That Met QC Criteria: March 28, 2011
• First Posted (Estimate): March 29, 2011

Study Record Updates

• Last Update Posted (Actual): May 10, 2017
• Last Update Submitted That Met QC Criteria: May 9, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Edentulism in the Upper Jaw
• Other Study ID Numbers: YA-OTX-0001