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

Adrià Jorba García

Status: Completed

Conditions: Dental Implants; Surgery, Computer-Assisted

Treatments: Procedure: Double Factor technique

Study type: Observational

Funder types: Other

Identifiers

NCT05512845

Double Factor

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Fully edentulous patients or with terminal dentition that requires an implant supported rehabilitation
• Healthy patients ASA I and II (American Society of Anesthesiologists classification)
• Over 18 years old patients

Exclusion criteria

• Partially edentulous patients
• Systemic or local conditions that contraindicates dental implant surgery

Trial design

10 participants in 1 patient group

Double factor group

Description:

Patients treated with full arch implant supported prostheses based on the All-on-four® concept. All implants were placed using the "double factor" computer assisted surgery technique, which involves combination of the static and dynamic computer assisted surgery protocols.

Treatment:

Procedure: Double Factor technique