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

Dental Implants Clinical Trial

— DoubleFactor  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05512845
• Other study ID #: Double Factor
• Status: Completed
• Start date: September 1, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: August 2022
• Source: University of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 31, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Implants
• Mouth, Edentulous
• Surgery, Computer-Assisted

Intervention

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.

Locations

Country	Name	City	State
Spain	Clinica Perio&Implant	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Adrià Jorba García

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Jorba-García A, González-Barnadas A, Camps-Font O, Figueiredo R, Valmaseda-Castellón 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. Review. — View Citation

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]. — View Citation

Pomares-Puig C, Sánchez-Garcés MA, Jorba-García A. Dynamic and static computer-guided surgery using the double-factor technique for completely edentulous patients: A dental technique. J Prosthet Dent. 2021 Mar 30. pii: S0022-3913(21)00105-0. doi: 10.1016/j.prosdent.2021.02.022. [Epub ahead of print] — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.
Secondary	Patient-reported outcome measures (PROMs).	Patients perception during the surgery will be assessed using a designed questionnaire (Likert scale)	Seven postoperative days.
Secondary	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.
Secondary	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.