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

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ClinicalTrials.gov Identifier: NCT02218541
Recruitment Status : Completed
First Posted : August 18, 2014
Results First Posted : July 27, 2018
Last Update Posted : July 27, 2018
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
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 or disease Intervention/treatment Phase
Single Edentulous Space Device: abutment margin 0.5 mm subgingival Device: abutment margin 1.5 mm subgingival Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Fabrication of a Definitive Cad/Cam Titanium Abutment Prior to Guided Surgery: a Pilot Study.
Actual Study Start Date : October 2014
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Arm Intervention/treatment
abutment margin 0.5 mm subgingival
when fabricating an abutment to support the crown, the margin will be placed 0.5 mm below the gumline
Device: abutment margin 0.5 mm subgingival
abutment margin 1.5 mm subgingival
when fabricating the abutment to support the crown, the margin will be placed 1.5 mm below the gumline
Device: abutment margin 1.5 mm subgingival



Primary Outcome Measures :
  1. Number of Participants With Abutment Margin Exposure > 0 [ Time Frame: up to 6 months post surgery ]
    Margin exposure of the abutment between groups at 6 months post surgery.


Secondary Outcome Measures :
  1. Number of Participants With a Soft Tissue Response of Bleeding [ Time Frame: 6 months post surgery ]
    To assess the condition of the peri-implant mucosa, those with a soft tissue response of bleeding upon probing were counted. Fisher's exact test will be used after the site has been evaluated for presence of bleeding or not.

  2. Number of Participants With Provisional Crown Fit at Delivery [ Time Frame: 8 weeks post surgery ]
    To assess if the Provisional Crown was able to be cemented at time of abutment connection was reported as 'Yes' or 'No.'



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02218541


Locations
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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
Investigators
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Principal Investigator: Ingeborg De Kok, DDS University of North Carolina School of Dentistry
  Study Documents (Full-Text)

Documents provided by University of North Carolina, Chapel Hill:
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02218541    
Other Study ID Numbers: 13-2376
First Posted: August 18, 2014    Key Record Dates
Results First Posted: July 27, 2018
Last Update Posted: July 27, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases