The Effect of Platform Switching on Single Implants in the Esthetic Zone, Following Flapless Surgery and Early-Loading Protocols

NCT ID: NCT02173236

Last Updated: 2014-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2014-03-31

Brief Summary

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The impact of platform switching with flapless surgery on early-loaded single-tooth implants on esthetic outcomes.

Detailed Description

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Evaluation of clinical, radiographic and microbial outcomes of single implants with platform switching, compared to those with conventional platform.

Conditions

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the Impact of Platform-switching

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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platform-switched implants

platform-switched implants vs. platform-matched implants

Group Type EXPERIMENTAL

platform-matched implant

Intervention Type OTHER

platform-matched implants

platform-switched implants vs. platform-matched implants

Group Type ACTIVE_COMPARATOR

platform-switched implants

Intervention Type OTHER

Interventions

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platform-switched implants

Intervention Type OTHER

platform-matched implant

Intervention Type OTHER

Other Intervention Names

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SuperLine™, Dentium Inc., Cypress, CA Zimmer TSV™, Zimmer Dental Inc., Carlsbad, CA

Eligibility Criteria

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Inclusion Criteria

* Patients should be at least 18 years old and not currently pregnant
* Systemically healthy with no medical contraindications to implant surgery
* Having intact opposite tooth to proposed implant sites
* The edentulous ridge with minimal ridge deformities.

Exclusion Criteria

* unstable medical status or conditions which may compromise wound healing
* osseous metabolic disorders (e.g., osteoporosis, Paget's disease etc.)
* uncontrolled dental or periodontal diseases
* edentulous ridges with the presence of fibrous dysplasia, severe tissue undercut, residual root, as well as insufficient dimensions or volume
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Yung-Ting Hsu

resident, Graduate Periodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Graduate Periodontics, Department of Periodontics and Oral Medicine, University of Michigan School of Dentistry

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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UM-

Identifier Type: -

Identifier Source: org_study_id

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