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The Accuracy of s-CAIS Compared With c-LIS

M

Mahidol University

Status

Completed

Conditions

Dental Implant

Treatments

Other: Accuracy measurement

Study type

Interventional

Funder types

Other

Identifiers

NCT05361226
2019/DT071-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

25+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

s-CAIS (static computer aided implant surgery)
Experimental group
Description:
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.
Treatment:
Other: Accuracy measurement
c-LIS (conventional laboratory-guided implant surgery)
Active Comparator group
Description:
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.
Treatment:
Other: Accuracy measurement

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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