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

NCT03814655 | Completed

• 1 other identifier: MINEC 2/2019
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Partially Edentulous Maxilla; Partially Edentulous Mandible

Keywords

Dental implants; digital workflow; guided surgery

Outcome Measures

Primary Outcomes (1)

• Accuracy of dental implant insertion

  Accuracy is described, by the International Organization for Standardization (ISO) standard 5725-1, through the use of two parameters: trueness and precision. Trueness refers to the deviation between the actual dimension of the measured object and the resulting measurement, while precision indicates how closely repeated the measurements in a set are.

  6 weeks

Study Arms (2)

Full digital workflow

EXPERIMENTAL

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).

Procedure: Full digital workflow

Partially digital workflow

ACTIVE COMPARATOR

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).

Procedure: Partially digital workflow

Interventions

Full digital workflow PROCEDURE

Dental implants will be inserted usig a surgical guide performed after prosthetically driven treatment planning. The workflow will be full digital.

Full digital workflow

Partially digital workflow PROCEDURE

Dental implants will be inserted usig a surgical guide performed after prosthetically driven treatment planning. The workflow will be partially digital.

Partially digital workflow

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Concordia Dent Srl: lead
• Carol Davila University of Medicine and Pharmacy: collaborator
• MINEC: collaborator

Study Sites (2)

Concordia Dent Clinic

Bucharest, 041335, Romania

Location

"Carol Davila"University of Medicine and Pharmacy

Bucharest, Romania

Location

Related Publications (5)

• Seelbach P, Brueckel C, Wostmann B. Accuracy of digital and conventional impression techniques and workflow. Clin Oral Investig. 2013 Sep;17(7):1759-64. doi: 10.1007/s00784-012-0864-4. Epub 2012 Oct 21.

  PMID: 23086333 BACKGROUND

• Mehl A, Ender A, Mormann W, Attin T. Accuracy testing of a new intraoral 3D camera. Int J Comput Dent. 2009;12(1):11-28. English, German.

  PMID: 19213357 BACKGROUND

• Pinto A, Raffone C. Postextraction computer-guided implant surgery in partially edentate patients with metal restorations: a case report. Oral Implantol (Rome). 2017 Apr 10;10(1):71-77. doi: 10.11138/orl/2017.10.1.071. eCollection 2017 Jan-Mar.

  PMID: 28757938 BACKGROUND

• Joda T, Ferrari M, Braegger U. A digital approach for one-step formation of the supra-implant emergence profile with an individualized CAD/CAM healing abutment. J Prosthodont Res. 2016 Jul;60(3):220-3. doi: 10.1016/j.jpor.2016.01.005. Epub 2016 Feb 9.

  PMID: 26868927 BACKGROUND

• Cristache CM, Gurbanescu S. Accuracy Evaluation of a Stereolithographic Surgical Template for Dental Implant Insertion Using 3D Superimposition Protocol. Int J Dent. 2017;2017:4292081. doi: 10.1155/2017/4292081. Epub 2017 May 7.

  PMID: 28555157 BACKGROUND

Study Officials

• Corina Marilena Cristache, DMD, PhD

  Carol Davila University of Medicine and Pharmacy

  PRINCIPAL INVESTIGATOR

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: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer, DMD, PhD, Dr. Habil., Oral and Maxillofacial Surgeon, Project responsable

Model Details: 54 partially edentulous patients filling the inclusion criteria and with signed consent form are expected to be enrolled in this RCT. Each patient will be randomly assigned to one of the following protocol for dental implant insertion: * Full digital workflow (n=27 patients/sites), * Partially digital workflow (n=27 patients/sites).

Study Record Dates

• First Submitted: January 20, 2019
• First Posted: January 24, 2019
• Study Start: July 1, 2019
• Primary Completion: February 15, 2020
• Study Completion: July 13, 2020
• Last Updated: July 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

RO (2)