An observational study in Surgery, Computer-Assisted and Dental Implants, sponsored by Adrià Jorba García. Completed at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-23.
Sponsored by Adrià Jorba García · Observational
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.
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.
244 studies on the registry are indexed under Mouth, Edentulous; 37 are open to participants now.
This study's enrollment of 10 is below the median of 39 across 52 observational studies indexed under Mouth, Edentulous.
Browse Mouth, Edentulous studies →Adrià Jorba García is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
All consecutive edentulous patients or with terminal dentition treated with full arch implant supported prostheses based on the All-on-four® concept and the computer assisted surgery "double factor" technique will be included in the trial.
Exclusion Criteria:
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.
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.
Also known as: Dynamic and static computer assisted surgery
Angular deviation
Angular deviation between the virtual planed position of the implant and the final implant position. Measured in degrees
Time frame: The day of the surgery
Platform 3D deviation
global deviation at the platform of the dental implant between the virtual planned position and the final position of the dental implant measured in the 3 axes of the space (3D deviation). Measured in millimeters (mm).
Time frame: The day of the surgery
APex 3D deviation
global deviation at the apex of the dental implant between the virtual planned position and the final position of the dental implant measured in the 3 axes of the space (3D deviation). Measured in millimeters (mm).
Time frame: The day of the surgery
Platform 2D deviation
Lateral deviation at the platform of the dental implant between the virtual planned position and the final position of the dental implant measured in 2 axes of the space (x and y, 2D deviation). Measured in millimeters (mm).
Time frame: The day of the surgery
Apex depth deviation
Depth deviation of the apex of the dental implant between the virtual planned position and the final position of the dental implant in the Z-axis. Measured in millimeters (mm).
Time frame: The day of the surgery
Patient-reported outcome measures (PROMs).
Patients perception of their functional well-being and health status during the dental implant treatment with a the "double factor" technique. We will use OHIP-14 (Oral Health Impact Profile) questionnaire.
Time frame: Seven postoperative days.
Patient-reported outcome measures (PROMs).
Patients perception during the surgery will be assessed using a designed questionnaire (Likert scale)
Time frame: Seven postoperative days.
Postoperative pain
A registration of the postoperative pain using a Visual Analog Scale (VAS) from 0mm to 100mm, meaning 0mm no pain and 100mm the maximum pain.
Time frame: Seven postoperative days.
Analgesic medication consumption record
The patient will be asked to record all the analgesic medication intake during the first 7 postoperative days.
Time frame: Seven postoperative days.
Plan to share: No
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Adrià Jorba García