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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill Identifier:
First received: August 14, 2014
Last updated: May 2, 2017
Last verified: May 2017
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: Participant
Primary Purpose: Treatment
Official Title: Fabrication of a Definitive Cad/Cam Titanium Abutment Prior to Guided Surgery: a Pilot Study.

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 ]
    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 ]
    measurement of the soft tissue response based on the condition of the peri-implant mucosa using bleeding on probing

Enrollment: 28
Actual Study Start Date: October 2014
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: May 2017 (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


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 identifier: NCT02218541

United States, North Carolina
Graduate Prosthodontic Clinic, Dept. of Prosthodontics, UNC School of Dentistry
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Principal Investigator: Ingeborg De Kok, DDS University of North Carolina School of Dentistry
  More Information

Responsible Party: University of North Carolina, Chapel Hill Identifier: NCT02218541     History of Changes
Other Study ID Numbers: 13-2376
Study First Received: August 14, 2014
Last Updated: May 2, 2017 processed this record on May 22, 2017