The Accuracy of s-CAIS Compared With c-LIS

NCT05361226 | Completed DMC

• 1 other identifier: 2019/DT071-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implant

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The accuracy of 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 Outcomes (1)

• Factors influencing the accuracy of implant placement

  Three months after implant placement

Study Arms (2)

s-CAIS (static computer aided implant surgery)

EXPERIMENTAL

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

c-LIS (conventional laboratory-guided implant surgery)

ACTIVE COMPARATOR

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

Interventions

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.

c-LIS (conventional laboratory-guided implant surgery); s-CAIS (static computer aided implant surgery)

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Dentistry, Mahidol University

Ratchathewi, Bangkok, 10400, Thailand

Location

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MeSH Terms

Interventions

Dimensional Measurement Accuracy

Intervention Hierarchy (Ancestors)

Reproducibility of Results; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Evaluation Studies as Topic; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 10, 2022
• First Posted: May 4, 2022
• Study Start: July 9, 2019
• Primary Completion: July 30, 2020
• Study Completion: October 30, 2020
• Last Updated: May 4, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)