Accuracy of Computer Guided Implant Surgery

Jaw, Edentulous Clinical Trial

— STIMPLANTSRG  

Official title:

Accuracy of Computer Guided Implant Surgery With the Use of R2Gate Stereolitographic Template

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02418117
• Other study ID #: 613/15
• Status: Completed
• Phase: N/A
• First received: April 9, 2015
• Last updated: January 26, 2016
• Start date: July 2015
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Concordia Dent Srl
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: State Institute for Drug Control
• Study type: Interventional

Clinical Trial Summary

The investigators' aim is to evaluate the accuracy of the stereolitographic template comparing the final implant insertion to the planned implant position at coronal and apical level.

Clinical relevance:

• To identify factors influencing the surgical template imprecision.

• To overcome risk factors for surgical template imprecision.

• To suggest improvements for highly accuracy of the surgical template especially for immediate loading and avoiding the injury of anatomical structures.

Description:

Initial examination, panoramic radiograph to be performed and impression for stone models to be taken to all enrolled patients. For diagnosis accuracy, impression of the surgical site and the opposite arch is mandatory.

For fully edentulous and extensive edentulous subjects - Class III and IV according to the American College of Prosthodontists - ACP - a visible light cure record bases with occlusal rims will be manufactured for bite registration.

CBCT will be taken with a R2 tray filled with impression material or with record basis in centric relation (CR).

CBCT will be performed using same CT machine with a specific setup and alignment to allow accuracy and reproducibility.

A series of axially sliced image data will be obtained and exported to a personal computer in DICOM (Digital Imaging and Communications in Medicine) format.

Models, occlusal rims and R2 trays will be scanned and imported as STL (Stereo Lithography) files.

On the scan models, a virtual wax-up will be designed with the use of 3Shape CAD (Computer Aided Design) software and saved as STL file.

Matching CT and models scan data DICOM files obtained from CBCT and STL files will be imported in a treatment plan software R2GATE version 1.0.3 (Megagen Implant, Korea) and implant insertion will be planned according to the final restoration and bone anatomy.

AnyRidge Megagen implants will be used with length and diameters required by the clinical cases.

A stereolitographic template manufactured by DDX Europa, after final decision of treatment plan, will be used for dental implants insertion using a minimally invasive flapless approach.

To assess accuracy of the surgical template, a new CBCT with specific set-up and alignment after implant insertion will be performed.

Matching post-op CT with the planed position of the implants will be performed using the R2GATE software and measurements between the location of implants on CT at the time of planning and after implantation will be made at the coronal and apical levels to determine the distance between the implant and the planned position buccal, oral, mesial and distal by two independent researchers. Angulation between the implant position and the planned position at coronal and apical level will be also measured.

Statistical analysis will be performed. Teeth supported, mucosal supported and teeth-mucosal supported surgical stereolitographic template will be analyzed separately.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• fully or partially edentulous patients,

• good general healty with no contraindications for implant surgery,

• acceptance of dental implant treatment,

• acceptance of at least 2 CBCT (one at treatment planning and one after surgery)

Exclusion Criteria:

• limited bone volume with stadial bone graft requirement,

• limited mouth opening (imposible to use the surgical stent),

• parkinson desease (imposible to perform an accurate CBCT)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Jaw, Edentulous

Intervention

Other:
• Stereolitographic template
Flapless (atraumatic) dental implants insertion with the aid of a stereolitographic template.

Locations

Country	Name	City	State
Romania	Concordia Dent Clinic	Bucharest

Sponsors (3)

Lead Sponsor	Collaborator
Concordia Dent Srl	Carol Davila University of Medicine and Pharmacy, MEGAGEN DENTAL IMPLANT ROMANIA

Country where clinical trial is conducted

Romania, 

References & Publications (4)

Beretta M, Poli PP, Maiorana C. Accuracy of computer-aided template-guided oral implant placement: a prospective clinical study. J Periodontal Implant Sci. 2014 Aug;44(4):184-93. doi: 10.5051/jpis.2014.44.4.184. Epub 2014 Aug 28. — View Citation

Van Assche N, Vercruyssen M, Coucke W, Teughels W, Jacobs R, Quirynen M. Accuracy of computer-aided implant placement. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:112-23. doi: 10.1111/j.1600-0501.2012.02552.x. Review. — View Citation

Vasak C, Kohal RJ, Lettner S, Rohner D, Zechner W. Clinical and radiological evaluation of a template-guided (NobelGuide™) treatment concept. Clin Oral Implants Res. 2014 Jan;25(1):116-23. doi: 10.1111/clr.12038. Epub 2012 Sep 18. — View Citation

Yatzkair G, Cheng A, Brodie S, Raviv E, Boyan BD, Schwartz Z. Accuracy of computer-guided implantation in a human cadaver model. Clin Oral Implants Res. 2015 Oct;26(10):1143-9. doi: 10.1111/clr.12482. Epub 2014 Sep 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurements of accuracy after implants placement at coronal and apical level	Measurements between the location of implants on CT at the time of planning and after implantation will be made at the coronal and apical levels to determine the distance between the implant and the planned position buccal, oral, mesial and distal.	average 10 days	No