The Accuracy of s-CAIS Compared With c-LIS

April 28, 2022 updated by: Mahidol University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Ratchathewi, Bangkok, Thailand, 10400
        • Faculty of Dentistry, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: s-CAIS (static computer aided implant surgery)
For the s-CAIS group, Cone Beam Computed Tomography (CBCT) and full-arch optical scan were performed to provide digital information for implant planning software (coDiagnostix 9, Dental Wings GmbH, Chemnitz, Germany). The virtual implant was set on a three dimensional (3D) virtual jaws according to the prosthetically driven protocol by one postgraduate dentist and was confirmed by one experienced dentist. Static surgical template covering on occlusal part of 4 teeth anteroposteriorly was then fabricated via 3D printing machine (surgical guide resin, Form 2, Formlabs, Somerville, Massachusetts, USA). This surgical template would be used during surgery.
Other: Accuracy measurement
Three months following the implant placement, patients were called back to the implant clinic to record the actual implant position with the digital impression technique. Full mouth scans were done by using the intraoral scanner (Trios 3, 3Shape, Copenhagen, Denmark). The surface scans were then exported as an STL file and were imported to coDiagnostiX software. 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.
Active Comparator: c-LIS (conventional laboratory-guided implant surgery)

For the c-LIS group, a radiographic template (ORTHO Plast, prominent®, Chonburi, Thailand) was fabricated covering on occlusal part of 4 teeth anteroposteriorly according to diagnostic wax-up on the study model. A radiographic marker (gutta percha) was then filled in the created hole of the template and for used while taking CBCT image to verify marker position.

Next, a study model was scanned by laboratory surface scan (D900m, 3Shape, Copenhagen, Denmark). The STL file was imported to 3D printing devices and the resin model was fabricated (Dental LT clear resin, Form 2, Formlabs, Somerville, Massachusetts, USA).

Next, the same template that had been used for CBCT was used to place implant replicas in a resin model. The position of the implant replicas in the models were assumed as pre-operative planned implant position.
Other: Accuracy measurement
Three months following the implant placement, patients were called back to the implant clinic to record the actual implant position with the digital impression technique. Full mouth scans were done by using the intraoral scanner (Trios 3, 3Shape, Copenhagen, Denmark). The surface scans were then exported as an STL file and were imported to coDiagnostiX software. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Three months after implant placement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Factors influencing the accuracy of implant placement
Time Frame: Three months after implant placement
Various factors influencing the accuracy of implant placement were also analyzed including the type of arch (Maxilla vs. Mandible), side of the arch (Left vs. Right), implant location (Premolar vs. Molar), implant diameter (WN vs. RN), implant length (8 vs. 10 mm), ridge morphology (Broad (≥8mm) vs. Narrow (˂8mm), cortical bone thickness and cortical interference. The thickness of the cortical bone was evaluated at the center of the implant after the planned implant position was completely set in the coDiagnostiX program. If any parts of the planned implant involving against any cortical bone walls, it would count as having a cortical interference.
Three months after implant placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2019

Primary Completion (Actual)

July 30, 2020

Study Completion (Actual)

October 30, 2020

Study Registration Dates

First Submitted

April 10, 2022

First Submitted That Met QC Criteria

April 28, 2022

First Posted (Actual)

May 4, 2022

Study Record Updates

Last Update Posted (Actual)

May 4, 2022

Last Update Submitted That Met QC Criteria

April 28, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2019/DT071-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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