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The Accuracy of s-CAIS Compared With c-LIS

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05361226
Enrollment
40
Registered
2022-05-04
Start date
2019-07-09
Completion date
2020-10-30
Last updated
2022-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implant

Keywords

Clinical Research, static computer aided implant surgery, accuracy, Dental implant

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.

Interventions

OTHERAccuracy 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.

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

Forty participants were allocated to two study groups via the coin-tossing technique.

Eligibility

Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The accuracy of implant placementThree months after implant placementPatients 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

MeasureTime frameDescription
Factors influencing the accuracy of implant placementThree months after implant placementVarious 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.

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026