Periimplant Mucosa Dynamics Around Divergent and Concave Atlantis Abutment Transition Profiles

NCT01871220 | Completed Results

• 1 other identifier: 201302798
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Implant, Single-Tooth; Esthetics, Dental

Keywords

Implant Abutments; Oral Mucosa Changes; Implant Esthetics

Outcome Measures

Primary Outcomes (1)

• Peri-Implant Mucosal Zenith Distance (in Millimeters) at the Concave/Divergent Abutment Sites

  Determine if there is a difference in soft tissue peri-implant zenith changes (in millimeters) for the concave/divergent abutment sites, specifically between at delivery and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery. This measurement is taken using a standardized stereotactic digital photography system that allows for increased measurement accuracy and precision, specifically with the Canfield Dental Camera, Canfield Imaging Systems.

  Delivery, and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery

Secondary Outcomes (2)

• Submarginal Buccal-lingual Thickness (Millimeters) in the Peri-implant Transition Zone Relative to a Fixed Reference Point After Prosthesis Delivery

  Baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery

• Keratinized Mucosa Width (Millimeters) at the Midfacial Aspect of the Implant Site.

  Baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery

Study Arms (2)

Divergent Abutment

ACTIVE COMPARATOR

Divergent Transition Profile

Device: Divergent Transition Profile

Concave Abutment

EXPERIMENTAL

Concave Transition Profile

Device: Concave Transition Profile

Interventions

Concave Transition Profile DEVICE

An Atlantis abutment is delivered with a concave transition profile.

Concave Abutment

Divergent Transition Profile DEVICE

An Atlantis abutment is delivered with a linear transition profile

Divergent Abutment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Christopher Barwacz: lead

Study Sites (1)

University of Iowa College of Dentistry

Iowa City, Iowa, 52242, United States

Location

Results Point of Contact

• Title: Dr. Christopher Barwacz
• Organization: University of Iowa College of Dentistry

chris-barwacz@uiowa.edu

3193843002

Study Officials

• Christopher A Barwacz, DDS

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 3, 2013
• First Posted: June 6, 2013
• Study Start: December 30, 2013
• Primary Completion: October 3, 2018
• Study Completion: October 3, 2018
• Last Updated: June 14, 2022
• Results First Posted: June 14, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)