Dental Implants, Surgery, Computer-Assisted
Conditions
Keywords
Dental Implants, Surgery, Computer-Assisted, Fully edentulous
Brief 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.
Interventions
PROCEDUREDouble 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.
Sponsors
Adrià Jorba García
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apex depth deviation | The day of the surgery | 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). |
| Platform 3D deviation | The day of the surgery | 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). |
| APex 3D deviation | The day of the surgery | 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). |
| Platform 2D deviation | The day of the surgery | 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). |
| Angular deviation | The day of the surgery | Angular deviation between the virtual planed position of the implant and the final implant position. Measured in degrees |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | Seven postoperative days. | 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. |
| Analgesic medication consumption record | Seven postoperative days. | The patient will be asked to record all the analgesic medication intake during the first 7 postoperative days. |
| Patient-reported outcome measures (PROMs). | Seven postoperative days. | 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. |
Countries
Spain
Outcome results
None listed