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Completed

NCT Number: NCT05361226

The Accuracy of s-CAIS Compared With c-LIS

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.

Completed

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Key information

Conditions

Dental Implant

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Mahidol University

Ratchathewi, Bangkok, 10400, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Accuracy measurement

Other

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.

Primary outcomes

  1. 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

  1. 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.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 4, 2022
Registry last updated
May 4, 2022

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.

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