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

Not Applicable

Completed

• Conditions: Jaw, Edentulous, Partially

• Registration Number: NCT00746187
• Lead Sponsor: Dentsply Sirona Implants and Consumables

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Study First Submitted: 2008-09-02
• Study First Submitted QC: 2008-09-02
• Study First Posted: 2008-09-03
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2014-03-12
• Results First Submitted QC: 2014-03-12
• Results First Posted: 2014-04-16
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-14
• Last Update Posted: 2016-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Marginal Bone Level Changes	3 years after implant placement (baseline)	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 (baseline). Positive value indicates bone gain and negative value bone loss.

Trial Locations

Locations (2)

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, United States