Partially Edentulous PatientsNCT06417788
Dynamic Guided Implant Surgery VS Static Guided Surgery.
A study testing Dental implant placement and Static guided implant placement in people with Partially Edentulous Patients and Bone Crest of at Least 10 mm Length and 6 mm Width, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
This study aims to evaluate if dynamic-guided surgery is an accurate system for placing dental implants. Researchers will assess the dental implant accuracy of the dynamic guided system compared to the static pilot guide. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Partially Edentulous Patients, Bone Crest of at Least 10 mm Length and 6 mm Width, Patients of at Least 18 Years Old
- What is being tested?
- Dental implant placement and Static guided implant placement
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 30 May 2024to 30 Jun 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older,
- ASA type 1 or 2,
- Full mouth plaque scores up to 25% (O'LEARY TJ. The plaque control record 1972;43:38), -Partially edentulous with at least one missing tooth
- Having a bone crest of at least 10mm in length and 6mm in width.
Who cannot join
- medical conditions contraindicating surgery,
- untreated periodontal disease or caries
- the need for bone augmentation
- acute local infections
- history of head/neck radiation.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
Marques Guasch, +447453802813, jmarques@uic.es
Gargallo Albiol, +34637434270, jgargallo@uic.es
About this study
Official title: Dynamic Guided Implant Surgery VS Static Guided Surgery. A Pilot Randomized Clinical Trial.
This study aims to evaluate if dynamic-guided surgery is an accurate system for placing dental implants.
Researchers will assess the dental implant accuracy of the dynamic guided system compared to the static pilot guide.
Participants will:
- Receive implant treatment that will be placed by a dynamic or static pilot drill guided system.
- Receive post-operative radiological exam for comparative (on the same appointment).
- Conditions
- Partially Edentulous Patients, Bone Crest of at Least 10 mm Length and 6 mm Width, Patients of at Least 18 Years Old
- Being tested
- Dental implant placement, Static guided implant placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implant placementDevice
Also called dynamic guided implant placement
Dental implant placement guided by Navident® (ClaroNav Inc., Toronto, Canada)
Static guided implant placementProcedure or surgery
Also called control group
Dental implant placement guided by a stereolithographic pilot drill guide.
| Study group | Role | What they receive |
|---|---|---|
| Test group or Dynamic guided group | Experimental | in this arm, the position and angulation of the implant in the patient's mouth will be guided by a dynamic guided system. Receives: Device: Dental implant placement |
| Control group or Static guided group | Active comparator | In this arm, the position and angulation of the implant in the patient's mouth will be guided by a stereolitographic pilot drill guide. Receives: Procedure: Static guided implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant placement accuracy at the implant platform level
Implant placement accuracy compared with the implant planning. Expressed in mm.
Measured: The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes.
Implant placement accuracy at the implant apex level
Implant placement accuracy compared with the implant planning. Expressed in mm.
Measured: The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes.
Implant placement accuracy at an angular evel
Implant placement accuracy compared with the implant planning. Expressed in degrees.
Measured: The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes.
Implant placement accuracy at the vertical plane.
Implant placement accuracy compared with the implant planning. Expressed in mm.
Measured: The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start30 May 2024 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Partially Edentulous PatientsStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients who need dental implants and fulfill the inclusion criteria will be randomly allocated to test group (dynamic guided system) or control group (static stereolithographic pilot drill guided system)
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordi Marquès Guasch, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417788
- Sponsor's protocol ID
- CIR-ECL-2018-09
- Status last verified
- May 2024
- First submitted
- 13 May 2024
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to publish the IPD.
Publications
Somogyi-Ganss E, Holmes HI, Jokstad A. Accuracy of a novel prototype dynamic computer-assisted surgery system. Clin Oral Implants Res. 2015 Aug;26(8):882-890. doi: 10.1111/clr.12414. Epub 2014 May 19.
PubMed 24837492Van Assche N, Vercruyssen M, Coucke W, Teughels W, Jacobs R, Quirynen M. Accuracy of computer-aided implant placement. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:112-23. doi: 10.1111/j.1600-0501.2012.02552.x.
PubMed 23062136Hultin M, Svensson KG, Trulsson M. Clinical advantages of computer-guided implant placement: a systematic review. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:124-35. doi: 10.1111/j.1600-0501.2012.02545.x.
PubMed 23062137Block MS, Emery RW, Lank K, Ryan J. Implant Placement Accuracy Using Dynamic Navigation. Int J Oral Maxillofac Implants. 2017 Jan/Feb;32(1):92-99. doi: 10.11607/jomi.5004. Epub 2016 Sep 19.
PubMed 27643585D'haese J, Ackhurst J, Wismeijer D, De Bruyn H, Tahmaseb A. Current state of the art of computer-guided implant surgery. Periodontol 2000. 2017 Feb;73(1):121-133. doi: 10.1111/prd.12175.
PubMed 28000275Sun TM, Lan TH, Pan CY, Lee HE. Dental implant navigation system guide the surgery future. Kaohsiung J Med Sci. 2018 Jan;34(1):56-64. doi: 10.1016/j.kjms.2017.08.011. Epub 2017 Dec 8.
PubMed 29310817Block MS, Emery RW. Static or Dynamic Navigation for Implant Placement-Choosing the Method of Guidance. J Oral Maxillofac Surg. 2016 Feb;74(2):269-77. doi: 10.1016/j.joms.2015.09.022. Epub 2015 Sep 30.
PubMed 26452429O'Leary TJ, Drake RB, Naylor JE. The plaque control record. J Periodontol. 1972 Jan;43(1):38. doi: 10.1902/jop.1972.43.1.38. No abstract available.
PubMed 4500182Hendrix JM, Garmon EH. American Society of Anesthesiologists Physical Status Classification System. 2025 Feb 11. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK441940/
PubMed 28722969
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Guided Implant Surgery VS Static Guided Surgery. A Pilot Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06417788
- Acronym / sponsor ID
- CIR-ECL-2018-09
- Conditions
- Partially Edentulous Patients, Bone Crest of at Least 10 mm Length and 6 mm Width, Patients of at Least 18 Years Old
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 30 May 2024 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 16 May 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.
This study aims to evaluate if dynamic-guided surgery is an accurate system for placing dental implants.
Researchers will assess the dental implant accuracy of the dynamic guided system compared to the static pilot guide.
Participants will:
- Receive implant treatment that will be placed by a dynamic or static pilot drill guided system.
- Receive post-operative radiological exam for comparative (on the same appointment).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Patients who need dental implants and fulfill the inclusion criteria will be randomly allocated to test group (dynamic guided system) or control group (static stereolithographic pilot drill guided system)
| Arm | Type | Receives |
|---|---|---|
| Test group or Dynamic guided group | Experimental | Device: Dental implant placementin this arm, the position and angulation of the implant in the patient's mouth will be guided by a dynamic guided system. |
| Control group or Static guided group | Active comparator | Procedure: Static guided implant placementIn this arm, the position and angulation of the implant in the patient's mouth will be guided by a stereolitographic pilot drill guide. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older,
- ASA type 1 or 2,
- Full mouth plaque scores up to 25% (O'LEARY TJ. The plaque control record 1972;43:38), -Partially edentulous with at least one missing tooth
- Having a bone crest of at least 10mm in length and 6mm in width.
Key exclusion criteria (5 listed)
- medical conditions contraindicating surgery,
- untreated periodontal disease or caries
- the need for bone augmentation
- acute local infections
- history of head/neck radiation.
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 |
|---|---|---|
| Dental implant placementAlso: dynamic guided implant placementDental implant placement guided by Navident® (ClaroNav Inc., Toronto, Canada) | Device | Test group or Dynamic guided group |
| Static guided implant placementAlso: control groupDental implant placement guided by a stereolithographic pilot drill guide. | Procedure or surgery | Control group or Static guided group |
Primary outcome
Implant placement accuracy at the implant platform level
Time frame: The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes.
Implant placement accuracy compared with the implant planning. Expressed in mm.
Implant placement accuracy at the implant apex level
Time frame: The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes.
Implant placement accuracy compared with the implant planning. Expressed in mm.
Implant placement accuracy at an angular evel
Time frame: The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes.
Implant placement accuracy compared with the implant planning. Expressed in degrees.
Implant placement accuracy at the vertical plane.
Time frame: The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes.
Implant placement accuracy compared with the implant planning. Expressed in mm.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Background: PubMed 24837492Somogyi-Ganss E, Holmes HI, Jokstad A. Accuracy of a novel prototype dynamic computer-assisted surgery system. Clin Oral Implants Res. 2015 Aug;26(8):882-890. doi: 10.1111/clr.12414. Epub 2014 May 19.
- Background: PubMed 23062136Van Assche N, Vercruyssen M, Coucke W, Teughels W, Jacobs R, Quirynen M. Accuracy of computer-aided implant placement. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:112-23. doi: 10.1111/j.1600-0501.2012.02552.x.
- Background: PubMed 23062137Hultin M, Svensson KG, Trulsson M. Clinical advantages of computer-guided implant placement: a systematic review. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:124-35. doi: 10.1111/j.1600-0501.2012.02545.x.
- Background: PubMed 27643585Block MS, Emery RW, Lank K, Ryan J. Implant Placement Accuracy Using Dynamic Navigation. Int J Oral Maxillofac Implants. 2017 Jan/Feb;32(1):92-99. doi: 10.11607/jomi.5004. Epub 2016 Sep 19.
- Background: PubMed 28000275D'haese J, Ackhurst J, Wismeijer D, De Bruyn H, Tahmaseb A. Current state of the art of computer-guided implant surgery. Periodontol 2000. 2017 Feb;73(1):121-133. doi: 10.1111/prd.12175.
- Background: PubMed 29310817Sun TM, Lan TH, Pan CY, Lee HE. Dental implant navigation system guide the surgery future. Kaohsiung J Med Sci. 2018 Jan;34(1):56-64. doi: 10.1016/j.kjms.2017.08.011. Epub 2017 Dec 8.
- Background: PubMed 26452429Block MS, Emery RW. Static or Dynamic Navigation for Implant Placement-Choosing the Method of Guidance. J Oral Maxillofac Surg. 2016 Feb;74(2):269-77. doi: 10.1016/j.joms.2015.09.022. Epub 2015 Sep 30.
- Background: PubMed 4500182O'Leary TJ, Drake RB, Naylor JE. The plaque control record. J Periodontol. 1972 Jan;43(1):38. doi: 10.1902/jop.1972.43.1.38. No abstract available.
- Background: PubMed 28722969Hendrix JM, Garmon EH. American Society of Anesthesiologists Physical Status Classification System. 2025 Feb 11. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK441940/
- Individual participant dataSharing planned: Yes. Plan to publish the IPD.
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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 Dental implant placement and Static guided implant placement in people with Partially Edentulous Patients and Bone Crest of at Least 10 mm Length and 6 mm Width, 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 4 inclusion and 5 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 22 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant placement accuracy at the implant platform level (time frame: The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes.). The study lists 4 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 NCT06417788, which also lists 9 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 22 May 2024.