This trial is active, not recruiting.

Condition single edentulous space
Treatments abutment margin .5mm subgingival, abutment margin 1.5mm subgingival
Sponsor University of North Carolina, Chapel Hill
Start date October 2014
End date April 2017
Trial size 28 participants
Trial identifier NCT02218541, 13-2376


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose treatment
Masking participant
when fabricating an abutment to support the crown, the margin will be placed .5mm below the gumline
abutment margin .5mm subgingival
when fabricating the abutment to support the crown, the margin will be placed 1.5mm below the gumline
abutment margin 1.5mm subgingival

Primary Outcomes

Abutment margin exposure
time frame: up to 6 months post surgery

Secondary Outcomes

soft tissue response
time frame: 8 weeks post surgery, 3 months post surgery, 6 months post surgery

Eligibility Criteria

All participants from 18 years up to 99 years old.

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

Additional Information

Official title Fabrication of a Definitive Cad/Cam Titanium Abutment Prior to Guided Surgery: a Pilot Study.
Principal investigator Ingeborg De Kok, DDS
Trial information was received from ClinicalTrials.gov and was last updated in April 2017.
Information provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill.