Multi Centre Study Comparing OsseoSpeed TX With OsseoSpeed

Partial Edentulism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01324778
• Other study ID #: YA-OTX-0001
• Status: Completed
• Phase: N/A
• First received: March 22, 2011
• Last updated: May 9, 2017
• Start date: March 2011
• Est. completion date: December 2016

Study information

• Verified date: May 2017
• Source: Dentsply Sirona Implants
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Edentulism Nos
• Partial Edentulism

Intervention

Device:
• OsseoSpeed TX
OsseoSpeedTM TX implants of lengths 6-17 mm
• OsseoSpeed
OsseoSpeedTM implants of lengths 6-17 mm

Locations

Country	Name	City	State
Sweden	Specialisttandvården, Hallands sjukhus	Halmstad
Sweden	Avd. för Parodontologi / Avd. för Oral Protetik, Odontologiska Institutionen	Jönköping
Sweden	Specialist- och sjukhustandvården	Kalmar
Sweden	Centrum för Oral Rehablilitering	Linköping
Sweden	Colossseumkliniken Mölndal	Mölndal
Sweden	Käkkirurgiska kliniken / Protetikkliniken	Örebro
Sweden	Käkcentrum, Södersjukhuset	Stockholm
Sweden	Specialisttandvården, S:t Eriks Sjukhus	Stockholm
Sweden	Käkkirurgiska kliniken NÄL / Specialistcentrum Uddevalla sjukhus	Trollhättan
Sweden	Käkkirurgiska Kliniken/Protetikkliniken	Umeå
Sweden	Parodontologi kliniken och Protetik- och Bettfysiologiska kliniken	Växjö

Sponsors (1)

Lead Sponsor	Collaborator
Dentsply Sirona Implants

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Implant stability	Implant stability will be evaluated clinically/manually (recorded as stable yes/no)	At implant placement (inclusion) (day 1)
Secondary	Implant stability	Implant stability will be evaluated using Resonance Frequency Analysis (RFA)	At implant placement (inclusion) (day 1)
Secondary	Implant stability	Implant stability will be evaluated clinically/manually (recorded as stable yes/no)	At implant loading (10-12 weeks after implant placement)
Secondary	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