Surgery, Computer-AssistedDoubleFactorNCT05512845
The Double Factor Technique: a Computer-guided Implant Surgery Technique for Fully Edentulous Patients
An observational study of Surgery, Computer-Assisted and Dental Implants, run by Adrià Jorba García at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgery, Computer-Assisted, Dental Implants
- What is being tested?
- Double Factor technique
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2021to 31 Mar 2022
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Partially edentulous patients
- Systemic or local conditions that contraindicates dental implant surgery
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Surgery, Computer-Assisted, Dental Implants
- Being tested
- Double Factor technique
- Keywords
- Dental Implants, Surgery, Computer-Assisted, Fully edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double Factor techniqueProcedure or surgery
Also called Dynamic and static computer assisted surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Double Factor technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angular deviation
Angular deviation between the virtual planed position of the implant and the final implant position. Measured in degrees
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: The day of the surgery
Secondary outcomes (4)
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.
Measured: Seven postoperative days.
Patient-reported outcome measures (PROMs).
Patients perception during the surgery will be assessed using a designed questionnaire (Likert scale)
Measured: 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.
Measured: 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.
Measured: Seven postoperative days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start1 Sep 2021
- Primary completion1 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Surgery, Computer-AssistedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Adrià Jorba García
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Adrià Jorba García, University of Barcelona
- Investigators
- Adrià Jorba-García, DDS, MS, Principal investigator, University of BarcelonaCarmen Pomares-Puig, MD, DDS, Study chair, University of ValenciaM Angeles Sánchez-Garcés, MD, MS, PhD, Study chair, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05512845
- Sponsor's protocol ID
- Double Factor
- Acronym
- DoubleFactor
- Status last verified
- Aug 2022
- First submitted
- 18 Aug 2022
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25123770Pomares-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.
PubMed 33810850Pomares 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.
PubMed 20623040Jorba-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.
PubMed 33635397
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Double Factor Technique: a Computer-guided Implant Surgery Technique for Fully Edentulous Patients
- ClinicalTrials.gov ID
- NCT05512845
- Acronym / sponsor ID
- DoubleFactor / Double Factor
- Conditions
- Surgery, Computer-Assisted, Dental Implants
- Keywords
- Dental Implants, Surgery, Computer-Assisted, Fully edentulous
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Adrià Jorba GarcíaUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 23 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Double factor group | – | Procedure: Double Factor techniquePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Partially edentulous patients
- Systemic or local conditions that contraindicates dental implant surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Double Factor techniqueAlso: Dynamic and static computer assisted surgeryThe "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. | Procedure or surgery | Double factor group |
Primary outcome
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
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).
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).
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).
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).
4 secondary outcomes
Patient-reported outcome measures (PROMs).
Time frame: Seven postoperative days.
Patient-reported outcome measures (PROMs).
Time frame: Seven postoperative days.
Postoperative pain
Time frame: Seven postoperative days.
Analgesic medication consumption record
Time frame: Seven postoperative days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Background: PubMed 25123770Vercruyssen 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.
- Background: PubMed 33810850Pomares-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.
- Background: PubMed 20623040Pomares 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.
- Background: PubMed 33635397Jorba-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrià Jorba-García, DDS, MS principal investigator
University of Barcelona
Carmen Pomares-Puig, MD, DDS study chair
University of Valencia
M Angeles Sánchez-Garcés, MD, MS, PhD study chair
University of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, Computer-Assisted and Dental Implants, run by Adrià Jorba García at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angular deviation (time frame: The day of the surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05512845, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.