Multi Centre Study Comparing OsseoSpeed TX With OsseoSpeed

Not Applicable

Completed

• Conditions: Partial Edentulism; Edentulism Nos
• Interventions: Device: OsseoSpeed TX; Device: OsseoSpeed

• Registration Number: NCT01324778
• Lead Sponsor: Dentsply Sirona Implants and Consumables

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-22
• Study First Submitted QC: 2011-03-28
• Study First Posted: 2011-03-29
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-09
• Last Update Posted: 2017-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	OsseoSpeed TX	-
B	OsseoSpeed	-

Primary Outcome Measures

Name	Time	Method
Marginal Bone Level	One year after loading	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).

Secondary Outcome Measures

Name	Time	Method
Implant stability	At implant loading (10-12 weeks after implant placement)	Implant stability will be evaluated clinically/manually (recorded as stable yes/no)
Implant survival	One year after loading	Implant survival rate will be evaluated by clinically and radiographically counting the number of remaining implants from implant placement to one year after loading.

Trial Locations

Locations (11)

Specialisttandvården, Hallands sjukhus; 🇸🇪 Halmstad, Sweden

Colossseumkliniken Mölndal; 🇸🇪 Mölndal, Sweden

Specialisttandvården, S:t Eriks Sjukhus; 🇸🇪 Stockholm, Sweden

Avd. för Parodontologi / Avd. för Oral Protetik, Odontologiska Institutionen; 🇸🇪 Jönköping, Sweden

Specialist- och sjukhustandvården; 🇸🇪 Kalmar, Sweden

Centrum för Oral Rehablilitering; 🇸🇪 Linköping, Sweden

Käkkirurgiska Kliniken/Protetikkliniken; 🇸🇪 Umeå, Sweden

Käkkirurgiska kliniken / Protetikkliniken; 🇸🇪 Örebro, Sweden

Käkcentrum, Södersjukhuset; 🇸🇪 Stockholm, Sweden

Käkkirurgiska kliniken NÄL / Specialistcentrum Uddevalla sjukhus; 🇸🇪 Trollhättan, Sweden

Parodontologi kliniken och Protetik- och Bettfysiologiska kliniken; 🇸🇪 Växjö, Sweden