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Clinical Trials/NCT05361226
NCT05361226
Completed
Not Applicable

The Accuracy of Static Computer-aided Implant Surgery Compared With Conventional Laboratory-guided Implant Surgery for Single-tooth Replacement: A Randomized Controlled Trial

Mahidol University1 site in 1 country40 target enrollmentJuly 9, 2019
ConditionsDental Implant

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Implant
Sponsor
Mahidol University
Enrollment
40
Locations
1
Primary Endpoint
The accuracy of implant placement
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

To compare the static computer-aided implant surgery (s-CAIS) and conventional laboratory-guided implant surgery (c-LIS) in terms of accuracy for single tooth replacement in posterior areas.

Detailed Description

There was still a lack of evidence in randomized clinical studies about the accuracy measurement comparing digital and laboratory workflows with tooth-supported templates for single implant cases in the posterior regions. Therefore, this present study's primary investigation was to perform accuracy measurement comparing digital and laboratory workflows with tooth-supported templates for single implant cases in the posterior regions. The secondary investigation was to find the effect of several factors on the accuracy of implant placement in these areas.

Registry
clinicaltrials.gov
Start Date
July 9, 2019
End Date
October 30, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients had a partially edentulous ridge in the premolar-molar region with existing two-sided interproximal as well as antagonistic contacts
  • Patients had healthy periodontal status and adequate keratinized gingiva at the edentulous space

Exclusion Criteria

  • - Patients have any local and systemic diseases considered as contraindications for dental implant treatment.

Outcomes

Primary Outcomes

The accuracy of implant placement

Time Frame: Three months after implant placement

Patients were called back to record the actual implant position with the the intraoral scanner (Trios 3, 3Shape, Copenhagen, Denmark). The surface scans were then exported as an STL file and were imported to coDiagnostiX software. Those postoperative surface scans were merged with the preoperative surface scan in each group protocols. The "Treatment evaluation tool" function tool was used to measure the accuracy of the implant placement which measured the amount of deviation of the placed implant from the planned position. The outcomes were generated into three main parameters which were Angular deviation, Coronal global deviation and Apical global deviation. Angular deviation = the amount of angle(°), in which the actually placed implant deviated from the virtually planned implant in 3D. Coronal/ Apical global deviation = the amount of distance(mm), in which the actually placed implant deviated from the virtually planned implant at the coronal/ apical position in 3D.

Secondary Outcomes

  • Factors influencing the accuracy of implant placement(Three months after implant placement)

Study Sites (1)

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