Clinical Trial: Accuracy of Dental Implant Placement Using Two Different CBCT-derived Templates

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Accuracy of Dental Implant Placement Using Two Different CBCT-derived Templates: a Randomized Controlled Clinical Trial

Brief Summary: The main purpose of the present study is to evaluate the dental implant placement using two different CBCT-derived templates and to study the related factors that affect accuracy so as to support the further clinical application of the technique. Thirty patients with partial edentulous denture are recruited. They are randomized to two groups. A radiographic guide is prepared before CT/CBCT scan. The CT/CBCT scan DICOM files are loaded in a planning program and converted into 3D computer images. A surgical template is fabricated through this virtual planning. After 6 weeks, if the implants are judged stable, the patient has the option of replacing the fixed prosthesis. Patients are recalled for oral hygiene maintenance and prosthetic controls every 6 months for the entire duration of the study.

Detailed Summary:
Sponsor: Sun Yat-sen University

Current Primary Outcome: Position changes between the planned and achieved implant position [ Time Frame: Change from preoperative to postoperative within 1 week ]

Accuracy analysis. The linear and angular deviations between the planned and achieved implant position are analyzed.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Implant and prosthesis survival [ Time Frame: Up to 18 months after baseline ]
    Implant and prosthesis survival will be determined at 6 months，12months and 18 months
  • Radiographic bone level [ Time Frame: Up to 18 months after baseline ]
    Radiographic bone level will be recorded at 6 months，12months and 18 months
  • The incidence of biological and mechanical complications [ Time Frame: Up to 18 months after baseline ]
    The incidence of biological and mechanical complications will be recorded at baseline, 6 months，12months and 18 months
  • Probing depth [ Time Frame: Up to 18 months after baseline ]
    Probing depth will be recorded at 6 months，12months and 18 months
  • Modified plaque index [ Time Frame: Up to 18 months after baseline ]
    Modified plaque index will be recorded at 6 months，12months and 18 months
  • Modified bleeding index [ Time Frame: Up to 18 months after baseline ]
    Modified bleeding index will be recorded at 6 months，12months and 18 months
  • Gingival index [ Time Frame: Up to 18 months after baseline ]
    Gingival index will be recorded at 6 months，12months and 18 months


Original Secondary Outcome: Same as current

Information By: Sun Yat-sen University

Dates:
Date Received: May 4, 2016
Date Started: August 2016
Date Completion: February 2018
Last Updated: August 15, 2016
Last Verified: May 2016