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Periimplant Mucosa Dynamics Around Divergent and Concave Atlantis Abutment Transition Profiles

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Iowa
Sponsor:
Information provided by (Responsible Party):
Barwacz, Christopher A, University of Iowa
ClinicalTrials.gov Identifier:
NCT01871220
First received: June 3, 2013
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to compare the effect of two different implant abutment designs on gum tissue volume changes over time after implant placement.


Condition Intervention Phase
Dental Implant, Single-Tooth
Esthetics, Dental
Device: Concave Transition Profile
Device: Divergent Transition Profile
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Peri-Implant Mucosal Zenith Changes [ Time Frame: 1, 3, 6, and 12 months ] [ Designated as safety issue: No ]
    Apico-coronal changes of the peri-implant mucosal zenith from prosthesis delivery to one year


Secondary Outcome Measures:
  • Comparison of bucco-linqual soft tissue thickness [ Time Frame: 1, 3, 6, and 12 months ] [ Designated as safety issue: No ]
    Submarginal bucco-lingual soft tissue thickness in the peri-implant transition zone relative to a fixed reference point.

  • Quantification of the soft tissue interface [ Time Frame: 1, 3, 6, and 12 months ] [ Designated as safety issue: No ]
    Quantification of the topographical and volumetric features of the interface between the peri-implant mucosa and the transition zone.

  • Keratinized mucosa width [ Time Frame: 1, 3, 6, and 12 months ] [ Designated as safety issue: No ]
    Keratinized mucosa width in an apicocoronal direction at the midfacial aspect of the implant site.

  • Gingival and Plaque Index, Bleeding on Probing, and Probing Pocket Depths [ Time Frame: 1, 3, 6, and 12 months ] [ Designated as safety issue: No ]
    Gingival Index (GI), Plaque Index (PI), Bleeding on probing (BOP) and probing pocket depths (PPD) at six sites (disto-lingual, mesio-lingual, mid-lingual, mesio-buccal, disto-buccal, mid-buccal).


Estimated Enrollment: 60
Study Start Date: September 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Divergent Abutment
Divergent Transition Profile
Device: Divergent Transition Profile
An Atlantis abutment is delivered with a linear transition profile
Experimental: Concave Abutment
Concave Transition Profile
Device: Concave Transition Profile
An Atlantis abutment is delivered with a concave transition profile.

Detailed Description:

This is a randomized, prospective, controlled clinical trial comparing the facial gingival profiles around Atlantis™ abutments that have either a linear "divergent" or "concave" transitional profile on the facial and proximal aspect of the abutments.

Sixty study subjects requiring replacement of a single-rooted tooth with an implant-supported restoration will be recruited.

The Osseospeed™ Plus implant will be placed for all 60 subjects, with the use of Uni healing abutments to minimize lateral tissue displacement during healing. After implant placement, but before final impressions are obtained (8 weeks post-placement), subjects will be randomized to either a "divergent" or a "concave" transmucosal abutment design. For fabrication of the experimental abutment, Atlantis™ engineers will initially design a control "divergent" prototype that will be modified with a concavity on the facial and proximal transition zones to obtain an abutment that will otherwise retain all the features of the control abutment. Engineers will measure the linear topographical changes (ΔL=Lc-Ld) of the transition zone, as well as the volumetric change (x) on the mid-facial aspect of the abutment induced by the formation of a submucosal concavity. The primary outcome of the study will be the apico-coronal change of the peri-implant mucosal zenith from prosthesis delivery to one year.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years of age or greater
  • Subjects requiring replacement of a single-rooted tooth in the maxillary arch from first premolar to first premolar with an implant-supported restoration
  • Teeth adjacent (mesial and distal) to study site must consist of two stable, natural teeth without signs of periodontal bone loss (<2.0mm) and/or significant soft tissue loss
  • An opposing dentition with teeth, implants, or fixed prosthesis
  • Subjects must be willing to follow instructions related to the study procedures
  • Subjects must have read, understood, and signed the informed consent document

Exclusion Criteria:

Exclusion Criteria:

  • Insufficient interocclusal space for implant placement and/or restoration at study site
  • More than 2.0mm vertical bone loss at study site as measured from the mid-buccal crest of the bone on the adjacent teeth
  • Untreated rampant caries
  • Tobacco use free for ≤ 6 months
  • Liver or kidney disfunction/failure
  • Active severe infectious diseases that may affect normal healing and/or bone metabolism (e.g. AIDS)
  • Uncontrolled diabetes
  • Current alcohol or drug abuse
  • Need for systemic corticosteroids or any other medication that would influence post-operative healing and/or osseointegration
  • History of relevant head/neck cancer and/or radiation of the head/neck
  • Subjects who currently use bisphosphonates or have a history of bisphosphonate use
  • Subjects with metabolic bone diseases such as osteoporosis or Paget's disease of bone
  • Known pregnancy or nursing mothers
  • Unable or unwilling to return for follow-up visits for a period of 1 year
  • Unlikely to be able to comply with study procedures according to investigators judgement
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01871220

Contacts
Contact: Lauren T Hughes, MSN, RN 319-335-7377 lauren-t-hughes@uiowa.edu

Locations
United States, Iowa
University of Iowa College of Dentistry Recruiting
Iowa City, Iowa, United States, 52242
Principal Investigator: Chris A Barwacz, DDS         
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Chris A Barwacz, DDS University of Iowa
  More Information

No publications provided

Responsible Party: Barwacz, Christopher A, Assistant Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT01871220     History of Changes
Other Study ID Numbers: D-2012-036
Study First Received: June 3, 2013
Last Updated: September 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
Implant Abutments
Oral Mucosa Changes
Implant Esthetics

ClinicalTrials.gov processed this record on August 21, 2014