Clinical trial NCT05512845: The Double Factor Technique: a Computer-guided Implant Surgery Technique for Fully Edentulous Patients
Official title: The Double Factor Technique: a Computer-guided Implant Surgery Technique for Fully Edentulous Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery, Computer-Assisted
Dental Implants
Keywords: Dental Implants
Surgery, Computer-Assisted
Fully edentulous
Lead sponsor: University of Barcelona
Sponsor class: OTHER
First posted: 2022-08-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Angular deviation
timeFrame: The day of the surgery
measure: Platform 3D deviation
timeFrame: The day of the surgery
measure: APex 3D deviation
timeFrame: The day of the surgery
measure: Platform 2D deviation
timeFrame: The day of the surgery
measure: Apex depth deviation
timeFrame: The day of the surgery
Secondary outcomes:
measure: Patient-reported outcome measures (PROMs).
timeFrame: Seven postoperative days.
measure: Patient-reported outcome measures (PROMs).
timeFrame: Seven postoperative days.
measure: Postoperative pain
timeFrame: Seven postoperative days.
measure: Analgesic medication consumption record
timeFrame: Seven postoperative days.
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Clinica Perio&Implant
Study officials:
affiliation: University of Barcelona
name: Adrià Jorba-García, DDS, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Valencia
name: Carmen Pomares-Puig, MD, DDS
role: STUDY_CHAIR
affiliation: University of Barcelona
name: M Angeles Sánchez-Garcés, MD, MS, PhD
role: STUDY_CHAIR
References:
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.
citation: 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.
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.
citation: 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.