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

Primary Purpose

Single Edentulous Space

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
abutment margin 0.5 mm subgingival
abutment margin 1.5 mm subgingival
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Single Edentulous Space

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Graduate Prosthodontic Clinic, Dept. of Prosthodontics, UNC School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

abutment margin 0.5 mm subgingival

abutment margin 1.5 mm subgingival

Arm Description

when fabricating an abutment to support the crown, the margin will be placed 0.5 mm below the gumline

when fabricating the abutment to support the crown, the margin will be placed 1.5 mm below the gumline

Outcomes

Primary Outcome Measures

Number of Participants With Abutment Margin Exposure > 0
Margin exposure of the abutment between groups at 6 months post surgery.

Secondary Outcome Measures

Number of Participants With a Soft Tissue Response of Bleeding
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.
Number of Participants With Provisional Crown Fit at Delivery
To assess if the Provisional Crown was able to be cemented at time of abutment connection was reported as 'Yes' or 'No.'

Full Information

First Posted
August 14, 2014
Last Updated
July 26, 2018
Sponsor
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT02218541
Brief Title
Fabrication of a Definitive Cad/Cam Titanium Abutment Prior to Guided Surgery: a Pilot Study.
Official Title
Fabrication of a Definitive Cad/Cam Titanium Abutment Prior to Guided Surgery: a Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Single Edentulous Space

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
abutment margin 0.5 mm subgingival
Arm Type
Other
Arm Description
when fabricating an abutment to support the crown, the margin will be placed 0.5 mm below the gumline
Arm Title
abutment margin 1.5 mm subgingival
Arm Type
Other
Arm Description
when fabricating the abutment to support the crown, the margin will be placed 1.5 mm below the gumline
Intervention Type
Device
Intervention Name(s)
abutment margin 0.5 mm subgingival
Intervention Type
Device
Intervention Name(s)
abutment margin 1.5 mm subgingival
Primary Outcome Measure Information:
Title
Number of Participants With Abutment Margin Exposure > 0
Description
Margin exposure of the abutment between groups at 6 months post surgery.
Time Frame
up to 6 months post surgery
Secondary Outcome Measure Information:
Title
Number of Participants With a Soft Tissue Response of Bleeding
Description
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.
Time Frame
6 months post surgery
Title
Number of Participants With Provisional Crown Fit at Delivery
Description
To assess if the Provisional Crown was able to be cemented at time of abutment connection was reported as 'Yes' or 'No.'
Time Frame
8 weeks post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingeborg De Kok, DDS
Organizational Affiliation
University of North Carolina School of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Graduate Prosthodontic Clinic, Dept. of Prosthodontics, UNC School of Dentistry
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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