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

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.

Study Overview

• Status: Completed
• Conditions: Dental Implants; Surgery, Computer-Assisted
• Intervention / Treatment: Procedure: Double Factor technique

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 Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain, 03007
    • Clinica Perio&Implant

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.; Other Names: Dynamic and static computer assisted surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angular deviation	Angular deviation between the virtual planed position of the implant and the final implant position. Measured in degrees	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).	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).	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).	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).	The day of the surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Adrià Jorba García
• Investigators: Principal Investigator: Adrià Jorba-García, DDS, MS, University of Barcelona; Study Chair: Carmen Pomares-Puig, MD, DDS, University of Valencia; Study Chair: M Angeles Sánchez-Garcés, MD, MS, PhD, University of Barcelona

Publications and helpful links

General Publications

• Vercruyssen M, Fortin T, Widmann G, Jacobs R, Quirynen M. Different techniques of static/dynamic guided implant surgery: modalities and indications. Periodontol 2000. 2014 Oct;66(1):214-27. doi: 10.1111/prd.12056.
• Pomares-Puig C, Sanchez-Garces MA, Jorba-Garcia A. Dynamic and static computer-guided surgery using the double-factor technique for completely edentulous patients: A dental technique. J Prosthet Dent. 2022 Nov;128(5):852-857. doi: 10.1016/j.prosdent.2021.02.022. Epub 2021 Mar 31.
• Pomares C. A retrospective study of edentulous patients rehabilitated according to the 'all-on-four' or the 'all-on-six' immediate function concept using flapless computer-guided implant surgery. Eur J Oral Implantol. 2010 Summer;3(2):155-63. Erratum In: Eur J Oral Implantol. 2011 Summer;4(2):125. Pomares Puig, Carmen [corrected to Pomares, Carmen].
• Jorba-Garcia A, Gonzalez-Barnadas A, Camps-Font O, Figueiredo R, Valmaseda-Castellon E. Accuracy assessment of dynamic computer-aided implant placement: a systematic review and meta-analysis. Clin Oral Investig. 2021 May;25(5):2479-2494. doi: 10.1007/s00784-021-03833-8. Epub 2021 Feb 26.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: August 18, 2022
• First Submitted That Met QC Criteria: August 20, 2022
• First Posted (Actual): August 23, 2022

Study Record Updates

• Last Update Posted (Actual): August 23, 2022
• Last Update Submitted That Met QC Criteria: August 20, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Dental Implants; Surgery, Computer-Assisted; Fully edentulous
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: Double Factor

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No