Clinical trial NCT03814655: Evaluation of the Accuracy of Full Digital Workflow for Guided Implant Surgery Using the R2 Gate Software
Official title: Evaluation of the Accuracy of Full Digital Workflow for Guided Implant Surgery Using the R2 Gate Software - a Randomized Clinical Trial (RCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Partially Edentulous Maxilla
Partially Edentulous Mandible
Keywords: Dental implants
digital workflow
guided surgery
Lead sponsor: Concordia Dent Srl
Sponsor class: OTHER
Collaborators: name: Carol Davila University of Medicine and Pharmacy
name: MINEC
First posted: 2019-01-24
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Accuracy of dental implant insertion
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Concordia Dent Clinic
city: Bucharest
country: Romania
facility: "Carol Davila"University of Medicine and Pharmacy
Study officials:
affiliation: Carol Davila University of Medicine and Pharmacy
name: Corina Marilena Cristache, DMD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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.
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.
citation: 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.