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

June 23, 2014 updated by: Yung-Ting Hsu, University of Michigan
The impact of platform switching with flapless surgery on early-loaded single-tooth implants on esthetic outcomes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-1078
        • Graduate Periodontics, Department of Periodontics and Oral Medicine, University of Michigan School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: platform-switched implants
platform-switched implants vs. platform-matched implants
Other: platform-matched implant
Other Names:
  • Zimmer TSV™, Zimmer Dental Inc., Carlsbad, CA
Active Comparator: platform-matched implants
platform-switched implants vs. platform-matched implants
Other: platform-switched implants
Other Names:
  • SuperLine™, Dentium Inc., Cypress, CA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
plaque index
Time Frame: crown placement
(Silness and Loe 1964). 0 represented the absence of plaque. 1 was the presence of plaque at gingival margin. 2 was the presence of visible plaque; whereas 3 was recorded if abundant plaque was observed
crown placement
plaque index
Time Frame: post-loading 3 months
(Silness and Loe 1964). 0 represented the absence of plaque. 1 was the presence of plaque at gingival margin. 2 was the presence of visible plaque; whereas 3 was recorded if abundant plaque was observed
post-loading 3 months
plaque index
Time Frame: post-loading 6 months
(Silness and Loe 1964). 0 represented the absence of plaque. 1 was the presence of plaque at gingival margin. 2 was the presence of visible plaque; whereas 3 was recorded if abundant plaque was observed
post-loading 6 months
plaque index
Time Frame: post-loading 12 months
(Silness and Loe 1964). 0 represented the absence of plaque. 1 was the presence of plaque at gingival margin. 2 was the presence of visible plaque; whereas 3 was recorded if abundant plaque was observed
post-loading 12 months
gingival index
Time Frame: crown placement
(Loe 1967) As for GI, normal gingival was scored as 0. 1 meant the presence of mild inflammation, slight change in color, slight edema and no BOP. Moderate inflammation was represented by 2, inclusive of the presence of gingival redness, edema, glazing and BOP. Severe inflammation with marked redness, edema, ulceration and spontaneous bleeding was scaled as 3
crown placement
gingival index
Time Frame: post-loading 3 months
As for GI, normal gingival was scored as 0. 1 meant the presence of mild inflammation, slight change in color, slight edema and no BOP. Moderate inflammation was represented by 2, inclusive of the presence of gingival redness, edema, glazing and BOP. Severe inflammation with marked redness, edema, ulceration and spontaneous bleeding was scaled as 3
post-loading 3 months
gingival index
Time Frame: post-loading 6 months
As for GI, normal gingival was scored as 0. 1 meant the presence of mild inflammation, slight change in color, slight edema and no BOP. Moderate inflammation was represented by 2, inclusive of the presence of gingival redness, edema, glazing and BOP. Severe inflammation with marked redness, edema, ulceration and spontaneous bleeding was scaled as 3
post-loading 6 months
gingival index
Time Frame: post-loading 12 months
As for GI, normal gingival was scored as 0. 1 meant the presence of mild inflammation, slight change in color, slight edema and no BOP. Moderate inflammation was represented by 2, inclusive of the presence of gingival redness, edema, glazing and BOP. Severe inflammation with marked redness, edema, ulceration and spontaneous bleeding was scaled as 3
post-loading 12 months
Papillary index
Time Frame: crown placement
(Jemt 1997) 0 = the absence of papilla, 1= <50% of the height of the gingival embrasure, 2= 50-99% of the height of the gingival embrasure, 3 = 100% of the proximal space, 4= overgrowth of the interproximal tissue
crown placement
Papillary index
Time Frame: post-loading 3 months
(Jemt 1997) 0 = the absence of papilla, 1= <50% of the height of the gingival embrasure, 2= 50-99% of the height of the gingival embrasure, 3 = 100% of the proximal space, 4= overgrowth of the interproximal tissue
post-loading 3 months
Papillary index
Time Frame: post-loading 6 months
(Jemt 1997) 0 = the absence of papilla, 1= <50% of the height of the gingival embrasure, 2= 50-99% of the height of the gingival embrasure, 3 = 100% of the proximal space, 4= overgrowth of the interproximal tissue
post-loading 6 months
Papillary index
Time Frame: post-loading 12 months
(Jemt 1997) 0 = the absence of papilla, 1= <50% of the height of the gingival embrasure, 2= 50-99% of the height of the gingival embrasure, 3 = 100% of the proximal space, 4= overgrowth of the interproximal tissue
post-loading 12 months
The width of keratinized mucosa
Time Frame: crown placement
measured at the midpoint on mid-facial surfaces of implants and adjacent two teeth.
crown placement
The width of keratinized mucosa
Time Frame: post-loading 3 months
measured at the midpoint on mid-facial surfaces of implants and adjacent two teeth.
post-loading 3 months
The width of keratinized mucosa
Time Frame: post-loading 6 months
measured at the midpoint on mid-facial surfaces of implants and adjacent two teeth.
post-loading 6 months
The width of keratinized mucosa
Time Frame: post-loading 12 months
measured at the midpoint on mid-facial surfaces of implants and adjacent two teeth.
post-loading 12 months
Soft tissue level
Time Frame: crown placement
the vertical distance from the gingival margin to the line connecting the facial gingival margin of two adjacent teeth
crown placement
Soft tissue level
Time Frame: post-loading 3 months
the vertical distance from the gingival margin to the line connecting the facial gingival margin of two adjacent teeth
post-loading 3 months
Soft tissue level
Time Frame: post-loading 6 months
the vertical distance from the gingival margin to the line connecting the facial gingival margin of two adjacent teeth
post-loading 6 months
Soft tissue level
Time Frame: post-loading 12 months
the vertical distance from the gingival margin to the line connecting the facial gingival margin of two adjacent teeth
post-loading 12 months
Probing depth
Time Frame: crown placement
Probing depth (PD) on the implant has also been recorded at 6 points mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual line-angles
crown placement
Probing depth
Time Frame: post-loading 3 months
Probing depth (PD) on the implant has also been recorded at 6 points mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual line-angles
post-loading 3 months
Probing depth
Time Frame: post-loading 6 months
Probing depth (PD) on the implant has also been recorded at 6 points mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual line-angles
post-loading 6 months
Probing depth
Time Frame: post-loading 12 months
Probing depth (PD) on the implant has also been recorded at 6 points mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual line-angles
post-loading 12 months
marginal bone level changes
Time Frame: post-operative 2 weeks, immediately after crown delivery, 3, 6, and 12 months post-loading
the vertical distance between alveolar crest to platform level (both mesial and distal)
post-operative 2 weeks, immediately after crown delivery, 3, 6, and 12 months post-loading
ridge height
Time Frame: prior to surgery
the distance from the highest point of alveolar crest to the base of the maxillary arch
prior to surgery
ridge height
Time Frame: post-loading 12 months
the distance from the highest point of alveolar crest to the base of the maxillary arch
post-loading 12 months
ridge width 3mm below crest
Time Frame: prior to surgery
the distance between the most prominent point on labial and palatal surfaces at the level of 3mm below the crest
prior to surgery
ridge width 3mm below crest
Time Frame: post-loading 12 months
the distance between the most prominent point on labial and palatal surfaces at the level of 3mm below the crest
post-loading 12 months
ridge width 10 mm below crest
Time Frame: prior to surgery
the distance between the most prominent point on labial and palatal surfaces at the level of 10 mm below the crest
prior to surgery
ridge width 10 mm below crest
Time Frame: post-loading 12 months
the distance between the most prominent point on labial and palatal surfaces at the level of 10 mm below the crest
post-loading 12 months
the presence of perforation or dehiscence
Time Frame: post-loading 1 year
using CBCT scan
post-loading 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
post-op experience
Time Frame: post-op 2weeks
pain, bleeding, swelling and overall discomfort
post-op 2weeks
microbial analysis
Time Frame: 12 months after loading
peri-implant microbial profile
12 months after loading
post-loading experience
Time Frame: post-op 12 months
comfort, function (chewing/speaking), esthetics, and overall satisfaction
post-op 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 19, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UM-

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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