Study to Compare Marginal Bone Loss Around Implants From Two Dental Implant Systems.

Jaw, Edentulous, Partially Clinical Trial

Official title:

An Open, Randomized Study to Compare Two Dental Implant Systems With Regard to Changes in Marginal Bone Level.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00746187
• Other study ID #: YA-MIC-0003
• Status: Completed
• Phase: N/A
• First received: September 2, 2008
• Last updated: March 12, 2014
• Start date: December 2002
• Est. completion date: June 2011

Study information

• Verified date: March 2014
• Source: Dentsply Implants
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare marginal bone level changes between ASTRA TECH Implant System; Fixture ST and Biomet 3i; Osseotite® Implants. Subjects with partial edentulism in the posterior maxilla and/or mandible will be included and a one-stage surgical protocol will be used. Implants will be loaded within 15 weeks from installation. The subjects will be followed for 3 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Provision of written informed consent

• Age 18 - 75 years

• Partial edentulism, Kennedy class I or II, last natural tooth must be cuspid or first bicuspid

• Edentulous in the area/s if implant placement for more than 2 months

Exclusion Criteria:

• Untreated caries and/or periodontal disease of residual dentition

• Need for pre-surgical bone or soft tissue augmentation in the planned implant area/s.

• Absence of occlusal stability in centric occlusion

• Any systemic or local 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

• Pregnancy

• Present alcohol or drug abuse

• Tobacco smoking during the last 6 months

• Unable or unwilling to return for follow-up visits for a period of 3 years

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Jaw, Edentulous
• Jaw, Edentulous, Partially

Intervention

Device:
• ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm.

• 3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm

Locations

Country	Name	City	State
United States	Dept. of Prosthodontics, School of Dentistry, University of North Carolina	Chapel Hill	North Carolina
United States	Dept. of Implant Dentistry, New York University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Dentsply Implants

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Marginal Bone Level Changes	Marginal bone adaptation was expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at the 3-year follow-up visit were compared to values obtained at Implant placement. Positive value indicates bone gain and negative value bone loss.	3 years after implant placement	No