Edentulous MouthNCT06255522
Clinical and Anatomical Factors Influencing Accuracy in Fully Guided Implant Placement.
A study testing Fully guided implant placement in people with Edentulous Mouth, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
The importance of the stability of hard and soft tissues has been shown to be of paramount importance for long-term implant success. To reach optimal functional and aesthetic outcomes, implant placement must be planned accordingly to prosthetic needs and design. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous Mouth
- What is being tested?
- Fully guided implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2024to 30 Nov 2024
- Phase
- Interventional
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients between 25 to 60 years old.
- Periodontally stable patients. Adequate oral hygiene with less than 15% Full Mouth Plaque Score (FMPS).
- Patients who need dental implant treatment without simultaneous regeneration.
- Ability to follow instructions and availability to attend for regular compliance during the entire study.
- With presence of partial edentulism (at least 6 remaining teeth distributed in the dental arch to support the guide).
Who cannot join
- Active infections
- Untreated periodontal disease
- Heavy smokers (>10 cigarettes per day)
- Drug / Alcohol dependency
- Medical condition contraindicating implants dependency
- Patients under bisphosphonate therapy
- Limited mouth opening
- Edentulous patients or with les than 6 teeth.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Clínica Blasi Barcelona
Barcelona, 08021
Gonzalo Blasi, DDS, MS, blasigonzalo@gmail.com
Ricardo Palacios-Bañuelos, DDS, MSc
About this study
Official title: Clinical and Anatomical Factors Influencing Accuracy in Fully Guided Implant Placement
The importance of the stability of hard and soft tissues has been shown to be of paramount importance for long-term implant success. To reach optimal functional and aesthetic outcomes, implant placement must be planned accordingly to prosthetic needs and design. Prosthetically driven implant placement is based on a diagnostic prosthetic set-up that is followed by precise implant planification and placement using CBCT and intraoral scanning.
The aim of this research is to evaluate how the clinical and anatomical factors can influence the 3D position of guided surgery.
Read the detailed description
After assessing the fulfillment of the inclusion criteria, pre-operative cone beam computed tomography (CBCT) (Newtom, Cefla S.C.) and intraoral digital impressions (Trios®, 3Shape Dental Systems, Denmark) will be obtained for each patient to achieve a digital wax-up and a presurgical plan for the exact position of the implants by a single calibrated operator (RP).
Every patient could have a maximum of four implants to be placed (one per quadrant), in those cases, each implant will be placed with its own surgical guide.
The digital imaging and communications in medicine (DICOM) files will be imported to a guided-surgery planning software (Codiagnostix, Dental wings) to perform an implant planning based on the digital wax up; in this step the assessment of the mucosal thickness will be performed using the STL and the DICOM files superimposed. The measurement will be taken from the crestal bone until the soft tissue surface (mm).
Furthermore, a surgical guide will be designed, and 3D printed (SprintRay Pro S; SprintRay Inc) with implant guide resin (SprintRay EU Surgical Guide Clear; SprintRay Inc) by RP for the surgical procedure, supported by the whole dental arch, and reinforced with one bar across the arch.
Through guided surgery, previously planned and designed based on CBCT study and CAD/CAM scanning, placement of Conelog Progressive line implants (Biohorizons Camlog, Iberia) will be performed in maxilla or mandibula in a one stage surgery by a 8 years' experience operator (GB).
Implant placement will be fully guided and a postoperative CBCT in ECO mode (35μSv) will be taken after the implant placement to assess the final position.
Both CBCT will be aligned (pre-op scan and post-op scan) to make calculations by a single evaluator (AB) included the following: (1) angle: angle deviation measured in degrees; (2) base: deviation at implant shoulder in millimeters; (3) tip: deviation at implant apex in millimeters; (4) 3D offset: global deviation in 3D directions in millimeters; (5) mesiodistal deviation in millimeters: (+) deviated to the distal direction and (-) deviated to the mesial direction; (6) buccolingual deviation in millimeters: direction: (+) deviated to lingual direction and (-) deviated to buccal direction; and (7) apicocoronally deviation in millimeters: direction: ( +) deviated in the apical direction. and (-) deviated in the coronal direction.
- Conditions
- Edentulous Mouth
- Being tested
- Fully guided implant placement
- Keywords
- Fully guided implant placement, Accuracy
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fully guided implant placementProcedure or surgery
Through guided surgery, previously planned and designed based on CBCT study and CAD/CAM scanning, implant placement of Conelog Progressive line implants (Biohorizons Camlog, Iberia) will be performed in maxilla or mandibula in a one stage surgery. Postoperative CBCT in ECO mode (35μSv) will be taken after the implant placement to assess the final position and comparing with the initial digital planning.
| Study group | Role | What they receive |
|---|---|---|
| Fully guided implant placement | Experimental | Through guided surgery implant placement will be performed in maxilla or mandibula in a one stage surgery. The final position will be compare with the initial digital implant planning. Receives: Procedure: Fully guided implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of fully guided implant placement
Both CBCT will be aligned (pre-op scan and post-op scan) to make calculations by a single evaluator (AB) included the following: (1) angle: angle deviation measured in degrees; (2) base: deviation at implant shoulder in millimeters; (3) tip: deviation at implant apex in millimeters; (4) 3D offset: global deviation in 3D directions in millimeters; (5) mesiodistal deviation in millimeters: (+) deviated to the distal direction and (-) deviated to the mesial direction; (6) buccolingual deviation in millimeters: direction: (+) deviated to lingual direction and (-) deviated to buccal direction; and (7) apicocoronally deviation in millimeters: direction: ( +) deviated in the apical direction. and (-) deviated in the coronal direction.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start1 Mar 2024
- Primary completion31 Oct 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous MouthStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gonzalo Blasi, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255522
- Sponsor's protocol ID
- REST-ECL-2023-08
- Status last verified
- May 2024
- First submitted
- 22 Nov 2023
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Anatomical Factors Influencing Accuracy in Fully Guided Implant Placement
- ClinicalTrials.gov ID
- NCT06255522
- Acronym / sponsor ID
- REST-ECL-2023-08
- Conditions
- Edentulous Mouth
- Keywords
- Fully guided implant placement, Accuracy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 13 Feb 2024 (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.
The importance of the stability of hard and soft tissues has been shown to be of paramount importance for long-term implant success. To reach optimal functional and aesthetic outcomes, implant placement must be planned accordingly to prosthetic needs and design. Prosthetically driven implant placement is based on a diagnostic prosthetic set-up that is followed by precise implant planification and placement using CBCT and intraoral scanning.
The aim of this research is to evaluate how the clinical and anatomical factors can influence the 3D position of guided surgery.
Detailed description
After assessing the fulfillment of the inclusion criteria, pre-operative cone beam computed tomography (CBCT) (Newtom, Cefla S.C.) and intraoral digital impressions (Trios®, 3Shape Dental Systems, Denmark) will be obtained for each patient to achieve a digital wax-up and a presurgical plan for the exact position of the implants by a single calibrated operator (RP).
Every patient could have a maximum of four implants to be placed (one per quadrant), in those cases, each implant will be placed with its own surgical guide.
The digital imaging and communications in medicine (DICOM) files will be imported to a guided-surgery planning software (Codiagnostix, Dental wings) to perform an implant planning based on the digital wax up; in this step the assessment of the mucosal thickness will be performed using the STL and the DICOM files superimposed. The measurement will be taken from the crestal bone until the soft tissue surface (mm).
Furthermore, a surgical guide will be designed, and 3D printed (SprintRay Pro S; SprintRay Inc) with implant guide resin (SprintRay EU Surgical Guide Clear; SprintRay Inc) by RP for the surgical procedure, supported by the whole dental arch, and reinforced with one bar across the arch.
Through guided surgery, previously planned and designed based on CBCT study and CAD/CAM scanning, placement of Conelog Progressive line implants (Biohorizons Camlog, Iberia) will be performed in maxilla or mandibula in a one stage surgery by a 8 years' experience operator (GB).
Implant placement will be fully guided and a postoperative CBCT in ECO mode (35μSv) will be taken after the implant placement to assess the final position.
Both CBCT will be aligned (pre-op scan and post-op scan) to make calculations by a single evaluator (AB) included the following: (1) angle: angle deviation measured in degrees; (2) base: deviation at implant shoulder in millimeters; (3) tip: deviation at implant apex in millimeters; (4) 3D offset: global deviation in 3D directions in millimeters; (5) mesiodistal deviation in millimeters: (+) deviated to the distal direction and (-) deviated to the mesial direction; (6) buccolingual deviation in millimeters: direction: (+) deviated to lingual direction and (-) deviated to buccal direction; and (7) apicocoronally deviation in millimeters: direction: ( +) deviated in the apical direction. and (-) deviated in the coronal direction.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fully guided implant placement | Experimental | Procedure: Fully guided implant placementThrough guided surgery implant placement will be performed in maxilla or mandibula in a one stage surgery. The final position will be compare with the initial digital implant planning. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients between 25 to 60 years old.
- Periodontally stable patients. Adequate oral hygiene with less than 15% Full Mouth Plaque Score (FMPS).
- Patients who need dental implant treatment without simultaneous regeneration.
- Ability to follow instructions and availability to attend for regular compliance during the entire study.
- With presence of partial edentulism (at least 6 remaining teeth distributed in the dental arch to support the guide).
Key exclusion criteria (8 listed)
- Active infections
- Untreated periodontal disease
- Heavy smokers (>10 cigarettes per day)
- Drug / Alcohol dependency
- Medical condition contraindicating implants dependency
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 |
|---|---|---|
| Fully guided implant placementThrough guided surgery, previously planned and designed based on CBCT study and CAD/CAM scanning, implant placement of Conelog Progressive line implants (Biohorizons Camlog, Iberia) will be performed in maxilla or mandibula in a one stage surgery. Postoperative CBCT in ECO mode (35μSv) will be taken after the implant placement to assess the final position and comparing with the initial digital planning. | Procedure or surgery | Fully guided implant placement |
Primary outcome
Accuracy of fully guided implant placement
Time frame: Baseline
Both CBCT will be aligned (pre-op scan and post-op scan) to make calculations by a single evaluator (AB) included the following: (1) angle: angle deviation measured in degrees; (2) base: deviation at implant shoulder in millimeters; (3) tip: deviation at implant apex in millimeters; (4) 3D offset: global deviation in 3D directions in millimeters; (5) mesiodistal deviation in millimeters: (+) deviated to the distal direction and (-) deviated to the mesial direction; (6) buccolingual deviation in millimeters: direction: (+) deviated to lingual direction and (-) deviated to buccal direction; and (7) apicocoronally deviation in millimeters: direction: ( +) deviated in the apical direction. and (-) deviated in the coronal direction.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fully guided implant placement in people with Edentulous Mouth, run by Universitat Internacional de Catalunya 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 9 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marta Valles, DDS, MSc, PhD (+34619747903, mvalles@uic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of fully guided implant placement (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2024.