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Fabrication of a Definitive Cad/Cam Titanium Abutment Prior to Guided Surgery: a Pilot Study.

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by University of North Carolina, Chapel Hill
Sponsor:
Information provided by (Responsible Party):
Ingeborg De Kok, DDS, MS, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT02218541
First received: August 14, 2014
Last updated: August 15, 2014
Last verified: August 2014
  Purpose

The study will involve placing a dental implant through a guided surgery protocol developed using 3D CT technology. Because the implant position is planned digitally using the CT data from the patient, this allows investigation of an abutment that supports the implant crown and soft tissues to be fabricated prior to implant placement. In doing so, this makes the protocol for patient care simpler and faster. In fabricating the the abutment prior to surgery, the investigators will design the abutments at different heights below the gumline to see an optimal margin height for fabrication of the abutment prior to surgery. The study hypothesis is that more often the abutment margin placed just slightly below (.5mm) the gumline will be visible about half of the time while the abutment margin placed further under the gumline (1.5mm) will be visible only about 10% of the time. The optimal outcome is that at delivery and follow-up, the abutment margin will not show intraorally.


Condition Intervention
Single Edentulous Space
Device: abutment margin .5mm subgingival
Device: abutment margin 1.5mm subgingival

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Abutment margin exposure [ Time Frame: up to 6 months post surgery ] [ Designated as safety issue: No ]
    to compare differences in margin exposure of the abutment between groups at baseline to 6 months post surgery


Secondary Outcome Measures:
  • soft tissue response [ Time Frame: 8 weeks post surgery, 3 months post surgery, 6 months post surgery ] [ Designated as safety issue: No ]
    measurement of the soft tissue response based on the condition of the peri-implant mucosa using bleeding on probing


Estimated Enrollment: 30
Study Start Date: August 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
abutment margin .5mm subgingival
when fabricating an abutment to support the crown, the margin will be placed .5mm below the gumline
Device: abutment margin .5mm subgingival
abutment margin 1.5mm subgingival
when fabricating the abutment to support the crown, the margin will be placed 1.5mm below the gumline
Device: abutment margin 1.5mm subgingival

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • partially edentulous with single edentulous space
  • edentulous site where previous tooth has been extracted for at least two months
  • minimum of 20 teeth present
  • able to tolerate dental implant surgical and restorative procedures
  • consent to participate in clinical trial

Exclusion Criteria:

  • asa class 3+
  • present drug use
  • is pregnant or plans to become pregnant
  • patients in need of lateral window sinus graft
  • patients in need of grafting prior to implant placement
  • patients in need of extensive grafting at time of implant placement
  • tooth is present or extracted within the last 2 months
  • history of IV bisphosphonate use or oral bisphosphonate use contraindicating dental implant therapy
  • untreated caries or periodontal disease
  • severe bruxism
  • smoker within past 6 months
  • unlikely to be able to comply with study procedures according to investigators
  • known allergy to any materials used in dental implant surgery
  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: NCT02218541

Contacts
Contact: William P Scruggs, DDS 919-537-3947 wscruggs@unc.edu

Locations
United States, North Carolina
Graduate Prosthodontic Clinic, Dept. of Prosthodontics, UNC School of Dentistry Not yet recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: William P Scruggs, DDS    919-537-3947    wscruggs@unc.edu   
Sub-Investigator: William P Scruggs, DDS         
Sub-Investigator: Lyndon F Cooper, DDS PhD         
Sponsors and Collaborators
Ingeborg De Kok, DDS, MS
Investigators
Principal Investigator: Ingeborg De Kok, DDS University of North Carolina School of Dentistry
  More Information

No publications provided

Responsible Party: Ingeborg De Kok, DDS, MS, Principal Investigator, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02218541     History of Changes
Other Study ID Numbers: 13-2376
Study First Received: August 14, 2014
Last Updated: August 15, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 25, 2014