Skip to main content
OpenTrials
Completed

NCT Number: NCT05512845

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Surgery, Computer-Assisted Dental Implants

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinica Perio&Implant

Alicante, 03007, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Dynamic and static computer assisted surgery

Primary outcomes

  1. Angular deviation

    Time frame: The day of the surgery

    Angular deviation between the virtual planed position of the implant and the final implant position. Measured in degrees

  2. Platform 3D deviation

    Time frame: 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).

  3. APex 3D deviation

    Time frame: 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).

  4. Platform 2D deviation

    Time frame: 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).

  5. Apex depth deviation

    Time frame: 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 outcomes

  1. Patient-reported outcome measures (PROMs).

    Time frame: Seven postoperative days.

    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.

  2. Patient-reported outcome measures (PROMs).

    Time frame: Seven postoperative days.

    Patients perception during the surgery will be assessed using a designed questionnaire (Likert scale)

  3. Postoperative pain

    Time frame: 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.

  4. Analgesic medication consumption record

    Time frame: Seven postoperative days.

    The patient will be asked to record all the analgesic medication intake during the first 7 postoperative days.

Sponsors and collaborators

Lead sponsor

Adrià Jorba García

Other

Registry information

Acronym: DoubleFactor

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 23, 2022
Registry last updated
Aug 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.