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

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.

Study Overview

• Status: Completed
• Conditions: Single Edentulous Space
• Intervention / Treatment: Device: abutment margin 0.5 mm subgingival; Device: abutment margin 1.5 mm subgingival

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Graduate Prosthodontic Clinic, Dept. of Prosthodontics, UNC School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Abutment Margin Exposure > 0	Margin exposure of the abutment between groups at 6 months post surgery.	up to 6 months post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months post surgery
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.'	8 weeks post surgery

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Ingeborg De Kok, DDS, University of North Carolina School of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: August 14, 2014
• First Submitted That Met QC Criteria: August 15, 2014
• First Posted (Estimate): August 18, 2014

Study Record Updates

• Last Update Posted (Actual): July 27, 2018
• Last Update Submitted That Met QC Criteria: July 26, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: 13-2376