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

NCT ID: NCT00746187

Last Updated: 2016-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-12-31
• Study Completion Date: 2011-06-30

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.

Conditions

Jaw, Edentulous, Partially

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ASTRA TECH Implant System; Fixture ST

Ø 4.5 cm in lengths 9-13 mm

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Biomet 3i; Osseotite® Implants

Ø 4.0 cm in lengths 8.5-13 mm

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Interventions

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

Intervention Type: DEVICE

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dentsply Sirona Implants and Consumables

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dennis P Tarnow, D.D.S. Prof.

Role: PRINCIPAL_INVESTIGATOR

Dept. of Implant Dentistry, New York University (to March 2011)

Stuart Froum, Dr

Role: PRINCIPAL_INVESTIGATOR

Dept. of Implant Dentistry, New York University (from March 2011)

Locations

Dept. of Implant Dentistry, New York University

New York, New York, United States

Dept. of Prosthodontics, School of Dentistry, University of North Carolina

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

YA-MIC-0003

Identifier Type: -

Identifier Source: org_study_id