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

NCT05512845 | Completed

• 1 other identifier: Double Factor
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery, Computer-Assisted; Dental Implants

Keywords

Dental Implants; Surgery, Computer-Assisted; Fully edentulous

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Patient-reported outcome measures (PROMs).

  Seven postoperative days.

• Patient-reported outcome measures (PROMs).

  Seven postoperative days.

• Postoperative pain

  Seven postoperative days.

• Analgesic medication consumption record

  Seven postoperative days.

Study Arms (1)

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

Interventions

Double Factor technique 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.

Also known as: Dynamic and static computer assisted surgery

Double factor group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Partially edentulous patients
• Systemic or local conditions that contraindicates dental implant surgery

Sponsors & Collaborators

• Adrià Jorba García: lead

Study Sites (1)

Clinica Perio&Implant

Alicante, 03007, Spain

Location

Related Publications (4)

• 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.

  PMID: 25123770 BACKGROUND

• 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.

  PMID: 33810850 BACKGROUND

• 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.

  PMID: 20623040 BACKGROUND

• 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.

  PMID: 33635397 BACKGROUND

Study Officials

• Adrià Jorba-García, DDS, MS

  University of Barcelona

  PRINCIPAL INVESTIGATOR

• Carmen Pomares-Puig, MD, DDS

  University of Valencia

  STUDY CHAIR

• M Angeles Sánchez-Garcés, MD, MS, PhD

  University of Barcelona

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 23, 2022
• Study Start: September 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 31, 2022
• Last Updated: August 23, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)