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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-03-31

Brief Summary

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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.

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Detailed Description

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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

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Surgery, Computer-Assisted Dental Implants

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Double factor group

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.

Double Factor technique

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Dynamic and static computer assisted surgery

Eligibility Criteria

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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