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OpenTrials
Completed

NCT Number: NCT02218541

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.

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Key information

Conditions

Single Edentulous Space

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

abutment margin 0.5 mm subgingival

Device

abutment margin 1.5 mm subgingival

Device

Primary outcomes

  1. Number of Participants With Abutment Margin Exposure > 0

    Time frame: up to 6 months post surgery

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

Secondary outcomes

  1. Number of Participants With a Soft Tissue Response of Bleeding

    Time frame: 6 months post surgery

    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.

  2. Number of Participants With Provisional Crown Fit at Delivery

    Time frame: 8 weeks post surgery

    To assess if the Provisional Crown was able to be cemented at time of abutment connection was reported as 'Yes' or 'No.'

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 18, 2014
Registry last updated
Jul 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.