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

Completed

• Conditions: Surgery, Computer-Assisted; Dental Implants
• Interventions: Procedure: Double Factor technique

• Registration Number: NCT05512845
• Lead Sponsor: Adrià Jorba García

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.

Study Timeline

• Study Start: 2021-09-01
• Primary Completion: 2022-03-01
• Study Completion: 2022-03-31
• Status Verified: 2022-08
• Study First Submitted: 2022-08-18
• Study First Submitted QC: 2022-08-20
• Last Update Submitted: 2022-08-20
• Study First Posted: 2022-08-23
• Last Update Posted: 2022-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Double factor group	Double Factor technique	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.

Primary Outcome Measures

Name	Time	Method
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
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).
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).

Secondary Outcome Measures

Name	Time	Method
Patient-reported outcome measures (PROMs).	Seven postoperative days.	Patients perception during the surgery will be assessed using a designed questionnaire (Likert scale)
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.

Trial Locations

Locations (1)

Clinica Perio&Implant; 🇪🇸 Alicante, Spain