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

Partially Edentulous Mandible Clinical Trial

— DIGIMPLGD  

Official title:

Evaluation of the Accuracy of Full Digital Workflow for Guided Implant Surgery Using the R2 Gate Software - a Randomized Clinical Trial (RCT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03814655
• Other study ID #: MINEC 2/2019
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: July 13, 2020

Study information

• Verified date: July 2020
• Source: Concordia Dent Srl
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 13, 2020
• Est. primary completion date: February 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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).

Related Conditions & MeSH terms

• Mouth, Edentulous
• Partially Edentulous Mandible
• Partially Edentulous Maxilla

Intervention

Procedure:
• Full digital workflow
Dental implants will be inserted usig a surgical guide performed after prosthetically driven treatment planning. The workflow will be full digital.
• Partially digital workflow
Dental implants will be inserted usig a surgical guide performed after prosthetically driven treatment planning. The workflow will be partially digital.

Locations

Country	Name	City	State
Romania	"Carol Davila"University of Medicine and Pharmacy	Bucharest
Romania	Concordia Dent Clinic	Bucharest

Sponsors (3)

Lead Sponsor	Collaborator
Concordia Dent Srl	Carol Davila University of Medicine and Pharmacy, MINEC

Country where clinical trial is conducted

Romania, 

References & Publications (5)

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. — View Citation

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. — View Citation

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

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. — View Citation

Seelbach P, Brueckel C, Wöstmann 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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