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NCT02218541 · ClinicalTrials.gov registry record · NA

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

A NA study of Single Edentulous Space, sponsored by University of North Carolina, Chapel Hill.

Completed
Registry status
NA
Development phase
22
Enrollment target
1
Study location

NCT02218541: Completed NA study of Single Edentulous Space, sponsored by University of North Carolina, Chapel Hill.

NCT02218541 is a NA study of Single Edentulous Space that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 22 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02218541, a NA study of Single Edentulous Space, has completed, sponsored by University of North Carolina, Chapel Hill.

COMPLETED
Registry status
NA
Development phase
22 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

Margin exposure of the abutment between groups at 6 months post surgery.

Conditions Studied

Interventions

  • DEVICE abutment margin 0.5 mm subgingival
  • DEVICE abutment margin 1.5 mm subgingival

Study Locations (1)

North Carolina

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

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2014-10
Est. Completion 2017-05
Phase NA

What the finished NCT02218541 record still lists

NCT02218541 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 1 condition, with Single Edentulous Space appearing as the primary indexed condition, and to 2 interventions - of which abutment margin 0.5 mm subgingival is the first listed.

NCT02218541 reports a single indexed study location in North Carolina.

Frequently Asked Questions

What is clinical trial NCT02218541 about?

NCT02218541 is a clinical study titled "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 fa...

What is the current status of trial NCT02218541?

This trial is currently completed. It is a NA study. The enrollment target is 22 participants. The study started on 2014-10. Estimated completion is 2017-05.

What conditions does trial NCT02218541 study?

This clinical trial studies the following conditions: Single Edentulous Space.

What interventions are being tested in trial NCT02218541?

The interventions under investigation include: abutment margin 0.5 mm subgingival (DEVICE), abutment margin 1.5 mm subgingival (DEVICE).

Who is sponsoring clinical trial NCT02218541?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02218541 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT02218541's enrollment target sits among peer trials

22 1756th of 2000 higher than 239 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02218541, the US trial registry maintained by the National Library of Medicine. NCT02218541 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.