Treatment With Fixture Microthread™ in Patients With Poor Bone Quality and no Teeth in the Upper Jaw, When Using Two-Stage Surgery

Jaw, Edentulous Clinical Trial

Official title:

An Open, Prospective, Multicenter Study to Evaluate Treatment of Edentulous Upper Jaws With an Implant-Supported Prosthesis Retained by Astra Tech Dental Implants, Fixture Micro-Macro in Patients With Poor Bone Quality

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00748670
• Other study ID #: YA-MMF-0003
• Status: Terminated
• Phase: N/A
• First received: September 5, 2008
• Last updated: September 5, 2008
• Start date: September 1999

Study information

• Verified date: September 2008
• Source: Dentsply Implants
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to evaluate the long-term survival rate of individual implants and prostheses when treating edentulous upper jaws of poor bone quality with Fixture MicroThread™ (Micro-Macro).

Clinical study recruitment was stopped in year 2000 due to a decision to modify the product under study. This was a result of feedback regarding the subjective feeling during the installation procedure. There were no safety concerns w/r to the study products. Patients already included and treated in the study were monitored for the full duration of the study in accordance with the clinical study protocol.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 18 - 75 years of age

• Bone quality class III or IV, (according to Lekholm & Zarb16)

• Willing to give signed informed consent

Exclusion Criteria:

• Need for bone augmentation of the maxilla

• Tobacco smoking more than 5 cigarettes/day

• Any systemic disease or condition that would compromise post-operative healing and/or osseointegration

• Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration

• Unable or unwilling to return for follow-up visits

• Bruxism or other parafunctional activity

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Jaw, Edentulous
• Mouth, Edentulous
• Poor Bone Quality

Intervention

Device:
• Fixture MicroThread (Micro-Macro)
Fixture MicroThread (Micro-Macro) Ø 3.5 and 4.0 mm in lengths of 9, 11, 13, 15 and 17 mm.

Locations

Country	Name	City	State
Sweden	Specialisttandvården, Avd för Oral Protetik, Länssjukhuset Gävle-Sandviken	Gävle
Sweden	Odontologiska kliniken, Länssjukhuset	Halmstad
United States	University of Iowa, College of Dentistry, Dow's Institute for Dental Research	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Dentsply Implants

Countries where clinical trial is conducted

United States,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant survival		Continuously during 5,5 years after implant placement	No