Evaluation of the Accuracy of Full Digital Workflow for Guided Implant Surgery Using the R2 Gate Software (DIGIMPLGD)

Concordia Dent

Status: Completed

Conditions: Partially Edentulous Maxilla; Partially Edentulous Mandible

Treatments: Procedure: Partially digital workflow; Procedure: Full digital workflow

Study type: Interventional

Funder types: Other

Identifiers

NCT03814655

MINEC 2/2019

Details and patient eligibility

About

The primary aim of the present study is to compare the accuracy of a full digital workflow for dental implants insertion to a partially digital workflow, for a limited edentulous space (1 to 3 dental units), in the maxilla or mandible.

Full description

Improvements of dental digital technologies are nowadays enabling clinicians to take the digital impressions of the dental arches, therefore avoiding the use of conventional impression materials. Digital impression procedures are claimed to be an approach to improve the accuracy of dental restorations by minimizing the error prone to conventional impression and gypsum model casting, enabling a high degree of standardization. Patients often prefer intraoral scan when compared to the traditional impression. Digital impression is also recommended when patients have remaining teeth that are extremely mobile or misaligned, due to the risk of exfoliation during the conventional impression procedure.

Despite its poor scientific and clinical evidence, the use of digital technologies into the daily practice registers a rapidly growing.

The precision of digital impressions depends on two different parameters: the resolution of the optical scanning system, and the precision of the matching algorithm which may significantly influence the precision of full arch scans. In order to minimize the effect of matching artifacts, only small parts of the dental arch in close vicinity of the teeth are recommended to be scanned.

For prosthetic restoration purpose, several studies regarding the accuracy of digital vs analogue impression have been performed, but none comparing the accuracy of digital vs partially digital workflow for prosthetically driven guided dental implant insertion.

Enrollment: 54 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Kennedy Class III partially edentulism with 3 or less missing teeth,
• Good general health with no contraindications for implant surgery,
• Acceptance of dental implant treatment,
• Acceptance of 1 or 2 CBCTs.

Exclusion criteria

• Limited bone volume with stadial bone graft requirement,
• Limited mouth opening (impossible to use the surgical stent),
• Parkinson disease (impossible to perform an accurate CBCT).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 2 patient groups

Full digital workflow

Experimental group

Description:

1. Intraoral scan of the partially edentulous site, antagonists and occlusion registration. Radiopaque tray customization over the partially edentulous arch. 2. CBCT with customized radiopaque tray. 3. Merging files in R2 Gate software and implant planning. 4. Guided implant insertion with immediate loading, if possible. Megagen dental implants will be inserted. 5. Digital impression for final screw-retained crown/bridge. 6. Assessment of accuracy by comparing stl files (planned and postimplant insertion).

Treatment:

Procedure: Full digital workflow

Partially digital workflow

Active Comparator group

Description:

1. Impression of the edentulous arch and antagonist, occlusion registration. Radiopaque tray customization over the edentulous arch. 2. CBCT with customized radiopaque tray. 3. Stone models alone, maximum intercuspal position and customized radiopaque tray will be scanned using a desktop scanner. 4. Merging files (CBCT and model stl) in R2 Gate software and implant planning. 5. Guided implant insertion with immediate loading, if possible. Megagen dental implants will be inserted. 6. Classic impression in customized tray with Impregum. 7. Functional models will be scanned using the same desktop scanner. 8. Final screw-retained crown/bridge manufacturing. 9. Assessment of accuracy by comparing stl files (planned and postimplant insertion).

Treatment:

Procedure: Partially digital workflow