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

NCT ID: NCT02218541

Last Updated: 2018-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2017-05-31

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.

Conditions

Single Edentulous Space

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: OTHER

abutment margin 0.5 mm subgingival

Intervention Type: DEVICE

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

Group Type: OTHER

abutment margin 1.5 mm subgingival

Intervention Type: DEVICE

Interventions

abutment margin 0.5 mm subgingival

Intervention Type: DEVICE

abutment margin 1.5 mm subgingival

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ingeborg De Kok, DDS

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina School of Dentistry

Locations

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

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

13-2376

Identifier Type: -

Identifier Source: org_study_id