NCT05512845

The Double Factor Technique: a Computer-guided Implant Surgery Technique for Fully Edentulous Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: Adrià Jorba García · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To overcome the limitations of the current dynamic and static Computer Assisted surgery protocols in fully edentulous patients, and combine the advantages of both approaches, a new technique has been developed, referred to as the "double factor" technique. This study consists in a single arm observational prospective clinical study and the aim was to assess the accuracy and patient's perception and quality of life of the "double factor" technique in treating fully edentulous patients.

Detailed description

This is a prospective observational clinical study. Each patient enrolled in this study will be treated using the "all on four concept" using the double factor technique. Preoperative virtual planification of dental implants on a pre-acquired cone beam computed tomography (CBCT) will be performed for each patient using the same system. During the surgical phase, four dental implant will be placed in a fully guided approach using "the double factor technique. This technique merges the static and dynamic computer-guided surgical approach in the same surgery. Then after the surgical procedure a PROMs questionnaire will be asked to the patients. Finally, a postoperative CBCT will be performed and overlapped with the preoperative CBCT (with the implants planification) and implant position deviations between the planned and final position will be measured. The study devices are CE- (Conformité Européenne, meaning European Conformity) marked products and used within their intended use.

Conditions

• Surgery, Computer-Assisted
• Dental Implants

Interventions

Type	Name	Description
PROCEDURE	Double Factor technique	The "double factor" computer assisted surgery technique, involves the combination of the static and dynamic computer assisted surgery protocols to place dental implants in the same surgery.

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-03-01
• Completion: 2022-03-31
• First posted: 2022-08-23
• Last updated: 2022-08-23

Locations

1 site across 1 country: Spain