Success Rate of Immediately Loaded Implants With Platform Switched Design Placed in Anterior Part of Mandible and Restored With Fixed Prostheses

NCT ID: NCT00780273

Last Updated: 2014-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2012-04-30

Brief Summary

Change in crestal bone level implants at 5% significance level.

Conditions

Edentulism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Ankylos dental implants.

3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.

A total number of 19 subjects participated in this randomized, split mouth, masked, prospective, open, comparison, monocenter study. Participants were subjects with an edentulous mandible who recieved 3 implants on each side which were splinted for the delivery of a fixed prosthesis.

Group Type: EXPERIMENTAL

Ankylos Implants

Intervention Type: DEVICE

ANKYLOS Implant System vs Certain PREVAIL Implant

3i Prevail dental implants.

Three 3i Prevail dental implants placed on the opposite side of the mandible from the Ankylos implants in support of fixed dental restoration.

After a baseline phase of 1 month the mandible sides of subjects were randomly assigned to one of the 2 parallel treatment groups: one side received ANKYLOS plus implants. The contralateral sde recieved Certain PREVAIL Implants. Abutments were installed and loaded immediately by a fixed temporary bridge. After 3 months the final prosthesis was incorporated.

Group Type: ACTIVE_COMPARATOR

Biomet 3i Prevail Implants

Intervention Type: DEVICE

Interventions

Ankylos Implants

ANKYLOS Implant System vs Certain PREVAIL Implant

Intervention Type: DEVICE

Biomet 3i Prevail Implants

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• age 18 to 80
• male or female (female non-pregnant)
• sufficient oral hygiene
• no inflammation/disorder in the area of implant site
• edentulous mandible and sufficient prosthetic and conservative
• sufficient width and height of bone to place implants with diameters of 4.8mm and length of 11 mm
• provide written informed consent

Exclusion Criteria

• demonstrate a need for pre-surgical bone or soft tissue augmentation in planned implant areas
• exhibit angulation requirements of restoration exceeding 15 degrees
• systemic metabolic disorder that would compromise post-operative tissue regeneration or osseointegration
• taking medication that would compromise post-operative healing and/or osseointegration
• bone disorders such as osteoporosis, hyperparathyroidism, Paget's disease, diabetes mellitus
• oncology treatment
• oral infection
• acute gingivitis and/or periodontitis
• local bone defects in the area of planned implantation
• disorders of oral mucosa (e.g., leukoplakia, oral lichen, pemphigoid lesions)
• received investigational drug within 30 days
• history of illicit drugs or alcohol abuse
• history of addiction to medication
• allergic to dental materials
• nicotine abuse (> 20 cigarettes/day)
• pregnant or nursing
• clinical significant or unstable medical or physiological conditions that would compromise participation in study
• unable or unwilling to return for follow-up visits for a period of 24 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dentsply International

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George Romanos, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester, Eastman Dept of Dentistry

Rochester, New York, United States

Countries

United States

Other Identifiers

DF 245

Identifier Type: -

Identifier Source: org_study_id