EdentulismNCT07364006
Accuracy of Metal Sleeve-Free Fully Guided Implant Surgery
A study testing Standard Drilling Channel Metal Sleeve-Free Surgical Guide and Reduced drilling channel Metal Sleeve-Free Surgical Guide in people with Edentulism, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
This clinical trial aims to evaluate the in vivo accuracy of fully guided dental implant surgery using 3D-printed surgical guides without metal sleeves. The study is designed as a split-mouth clinical trial and will be conducted in partially or fully edentulous adult patients requiring complete-arch rehabilitation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edentulism
- What is being tested?
- Standard Drilling Channel Metal Sleeve-Free Surgical Guide and Reduced drilling channel Metal Sleeve-Free Surgical Guide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Partially or fully edentulous patients requiring fixed complete-arch rehabilitation with dental implants.
- Patients classified as ASA I or ASA II.
- Adult patients aged 18 years or older.
- Ability to understand the study procedures and provide written informed consent.
Who cannot join
- Patients classified as ASA III or ASA IV.
- Patients with medical conditions that contraindicate dental implant surgery.
- Inability or unwillingness to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Solange J Vasquez Ramos, DDS, MSc contact
Spain1 site, 1 recruiting
- Recruiting
Universidad Complutense de Madrid
Madrid, Madrid, 28040
Miguel A Gomez Polo, DDS, PhD, mgomezpo@ucm.es
Juan Ballesteros, DDS, MSc
About this study
Official title: Evaluation of Accuracy in Fully Guided Dental Implant Surgery Using 3D-Printed Surgical Guides Without Metal Sleeves: A Split-Mouth In Vivo Study
This clinical trial aims to evaluate the in vivo accuracy of fully guided dental implant surgery using 3D-printed surgical guides without metal sleeves. The study is designed as a split-mouth clinical trial and will be conducted in partially or fully edentulous adult patients requiring complete-arch rehabilitation with dental implants.
The primary objective of the study is to assess the accuracy of implant placement by comparing the virtually planned implant positions with the actual clinical positions achieved after guided surgery. Accuracy will be evaluated by analyzing linear and angular deviations between planned and placed implants.
Read more
Participants will undergo a fully guided implant placement procedure using metal sleeve-free surgical guides. Two different drilling channel diameters (standard and reduced) will be randomly assigned in a split-mouth manner. Postoperative intraoral scans and cone-beam computed tomography (CBCT) scans with scan bodies will be obtained to register the final implant positions.
The planned and achieved implant positions will be compared using three-dimensional analysis software to quantify deviations and determine whether the use of metal sleeve-free guides and reduced drilling diameters influences implant placement accuracy.
Read the detailed description
Background. Computer-guided implant surgery is associated with a known loss of accuracy when compared with virtual implant planning, due to the influence of multiple clinical and technical factors. Deviations between planned and actual implant positions remain a relevant issue in guided implant surgery. Accuracy is commonly assessed by comparing virtually planned implant positions with postoperative implant positions using linear and angular deviation measurements. From a clinical perspective, improving the accuracy of guided implant placement is particularly relevant in complete-arch rehabilitations, where small deviations may affect prosthetic fit and clinical outcomes. Metal sleeves incorporated into surgical guides may contribute to mechanical tolerance between the drilling instrument and the guide, and reducing this tolerance could potentially improve accuracy.
Justification. Despite the widespread use of guided implant surgery, limited in vivo evidence exists regarding the effect of eliminating metal sleeves from surgical guides on implant placement accuracy. Additionally, the influence of reducing the drilling channel diameter on implant deviation relative to virtual planning has not been sufficiently evaluated. This study aims to determine whether the elimination of metal sleeves and the reduction of drilling channel diameter improve the accuracy of guided implant surgery. The findings may help clarify whether the use of metal sleeves is necessary and whether reducing the drilling channel diameter compared with manufacturer standards may decrease implant deviation by minimizing the gap between the drill and the guide.
Study Design. This study is designed as a prospective, single-center, interventional split-mouth clinical trial. An intraindividual comparison will be performed between two guided surgery conditions within the same patient.
Participants. The study population will consist of 15 partially or fully edentulous patients requiring fixed complete-arch rehabilitation with dental implants. Eligible participants will be patients classified as ASA I or II. Patients classified as ASA III or IV will be excluded. All participants will be required to meet the predefined inclusion criteria, none of the exclusion criteria, and will be required to provide written informed consent prior to participation.
Intervention. Virtual implant planning will be performed using guided surgery software by aligning DICOM data from cone-beam computed tomography scans with STL files of the maxillae obtained through intraoral scanning. A virtual diagnostic wax-up of the immediate-loading provisional restoration will be created to guide prosthetically driven implant planning. Following virtual planning, two drilling conditions will be randomly assigned in a split-mouth manner. On one side, drilling channels will be designed with the standard diameter recommended by the manufacturer for use with metal sleeves (4.85 mm). On the contralateral side, drilling channels will be designed with a reduced diameter of 4.83 mm. Surgical guides will be digitally designed, exported as STL files, and fabricated using three-dimensional printing technology with biocompatible surgical guide resin at a resolution of 35 microns. The guides will be sterilized in an autoclave at 134 °C for 5 minutes. Dental implants will be placed using the guided surgical templates.
Outcomes Assessment. After implant placement, postoperative intraoral scans with scan bodies will be obtained, and cone-beam computed tomography scans with scan bodies will be performed following a standardized imaging protocol. The planned and postoperative datasets will be compared to evaluate differences between virtual implant planning and actual implant placement. Measurements will be performed using reverse engineering software to calculate linear and angular deviations between planned and placed implants.
Statistical Analysis. Once data collection is completed, statistical analysis will be performed. Data normality will be assessed, and a chi-square test will be used to evaluate differences between the study conditions.
- Conditions
- Edentulism
- Being tested
- Standard Drilling Channel Metal Sleeve-Free Surgical Guide, Reduced drilling channel Metal Sleeve-Free Surgical Guide
- Keywords
- Guided implant surgery, Dental implants, Surgical guide accuracy, Metal sleeve-free surgical guides, 3D-printed surgical guides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Drilling Channel Metal Sleeve-Free Surgical GuideDevice
Fully guided dental implant surgery performed using 3D-printed surgical guides without metal sleeves. The guides are designed based on virtual implant planning and used to place dental implants with a standard drilling channel diameter in a split-mouth design.
Reduced drilling channel Metal Sleeve-Free Surgical GuideDevice
Fully guided dental implant surgery performed using 3D-printed surgical guides without metal sleeves. The guides are designed based on virtual implant planning and used to place dental implants with reduced drilling channel diameter in a split-mouth design.
| Study group | Role | What they receive |
|---|---|---|
| Standard Drilling Diameter | Experimental | Implant placement using metal sleeve-free 3D-printed surgical guides with a standard drilling channel diameter (4.85 mm). Receives: Device: Standard Drilling Channel Metal Sleeve-Free Surgical Guide |
| Reduced Drilling Diameter | Experimental | Implant placement using metal sleeve-free 3D-printed surgical guides with a reduced drilling channel diameter (4.83 mm). Receives: Device: Reduced drilling channel Metal Sleeve-Free Surgical Guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Drilling Channel Diameter on Implant Placement Accuracy
Implant placement accuracy will be compared between implants placed using fully guided surgical guides with a standard drilling channel diameter (4.85 mm) and those placed using a reduced drilling channel diameter (4.83 mm). Linear deviations at the coronal and apical implant levels, as well as angular deviations of the implant axis, relative to the virtual implant planning will be measured to determine whether differences in accuracy exist between both drilling conditions.
Measured: Immediately after implant placement
Secondary outcomes (1)
Deviation Between Planned and Actual Implant Positions
The linear and angular deviations between the virtually planned implant positions and the actual implant positions achieved after fully guided implant surgery will be evaluated to describe overall implant placement accuracy.
Measured: Immediately after implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 Oct 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for EdentulismStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- Split-mouth design with intraindividual comparison of two drilling channel diameters using metal sleeve-free surgical guides.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel Gómez Polo, Universidad Complutense de Madrid
- Investigators
- Juan Ballesteros, DDs, MSc, Principal investigator, Universidad Complutense de Madrid Juan Ballesteros- Martinez, DDs, MScMiguel A Gómez Polo, DDS, PhD, Study chair, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07364006
- Sponsor's protocol ID
- 24/764-E
- Status last verified
- Jan 2026
- First submitted
- 10 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gomez-Polo M, Ballesteros J, Padilla PP, Pulido PP, Revilla-Leon M, Ortega R. Merging intraoral scans and CBCT: a novel technique for improving the accuracy of 3D digital models for implant-supported complete-arch fixed dental prostheses. Int J Comput Dent. 2021 Jun 4;24(2):117-123.
PubMed 34085497Chen Z, Li J, Ceolin Meneghetti P, Galli M, Mendonca G, Wang HL. Does guided level (fully or partially) influence implant placement accuracy at post-extraction sockets and healed sites? An in vitro study. Clin Oral Investig. 2022 Aug;26(8):5449-5458. doi: 10.1007/s00784-022-04512-y. Epub 2022 May 2.
PubMed 35499656Pessoa R, Siqueira R, Li J, Saleh I, Meneghetti P, Bezerra F, Wang HL, Mendonca G. The Impact of Surgical Guide Fixation and Implant Location on Accuracy of Static Computer-Assisted Implant Surgery. J Prosthodont. 2022 Feb;31(2):155-164. doi: 10.1111/jopr.13371. Epub 2021 May 10.
PubMed 33904640Shah NP, Khanna A, Pai AR, Sheth VH, Raut SR. An evaluation of virtually planned and 3D-printed stereolithographic surgical guides from CBCT and digital scans: An in vitro study. J Prosthet Dent. 2022 Sep;128(3):436-442. doi: 10.1016/j.prosdent.2020.12.035. Epub 2021 Feb 12.
PubMed 33583616El Kholy K, Janner SFM, Schimmel M, Buser D. The influence of guided sleeve height, drilling distance, and drilling key length on the accuracy of static Computer-Assisted Implant Surgery. Clin Implant Dent Relat Res. 2019 Feb;21(1):101-107. doi: 10.1111/cid.12705. Epub 2018 Dec 27.
PubMed 30589502Hernandez-Margarit P, Palacios-Banuelos R, Roig M, Altuna P, Blasi A. Digital workflow for designing an interim implant-supported restoration with an optimal emergence profile in an open-source software program. J Prosthet Dent. 2024 Nov;132(5):857-862. doi: 10.1016/j.prosdent.2022.10.013. Epub 2022 Dec 6.
PubMed 36494239Derksen W, Wismeijer D, Flugge T, Hassan B, Tahmaseb A. The accuracy of computer-guided implant surgery with tooth-supported, digitally designed drill guides based on CBCT and intraoral scanning. A prospective cohort study. Clin Oral Implants Res. 2019 Oct;30(10):1005-1015. doi: 10.1111/clr.13514. Epub 2019 Sep 9.
PubMed 31330566Adams CR, Ammoun R, Deeb GR, Bencharit S. Influence of Metal Guide Sleeves on the Accuracy and Precision of Dental Implant Placement Using Guided Implant Surgery: An In Vitro Study. J Prosthodont. 2023 Jan;32(1):62-70. doi: 10.1111/jopr.13503. Epub 2022 Mar 22.
PubMed 35257456Abduo J, Lau D. Effect of Manufacturing Technique on the Accuracy of Surgical Guides for Static Computer-Aided Implant Surgery. Int J Oral Maxillofac Implants. 2020 Sep/Oct;35(5):931-938. doi: 10.11607/jomi.8186.
PubMed 32991643Henprasert P, Dawson DV, El-Kerdani T, Song X, Couso-Queiruga E, Holloway JA. Comparison of the Accuracy of Implant Position Using Surgical Guides Fabricated by Additive and Subtractive Techniques. J Prosthodont. 2020 Jul;29(6):534-541. doi: 10.1111/jopr.13161. Epub 2020 May 6.
PubMed 32147893Putra RH, Yoda N, Astuti ER, Sasaki K. The accuracy of implant placement with computer-guided surgery in partially edentulous patients and possible influencing factors: A systematic review and meta-analysis. J Prosthodont Res. 2022 Jan 11;66(1):29-39. doi: 10.2186/jpr.JPR_D_20_00184. Epub 2021 Jan 26.
PubMed 33504723Oh KC, Park JM, Shim JS, Kim JH, Kim JE, Kim JH. Assessment of metal sleeve-free 3D-printed implant surgical guides. Dent Mater. 2019 Mar;35(3):468-476. doi: 10.1016/j.dental.2019.01.001. Epub 2019 Jan 23.
PubMed 30685109Kernen F, Kramer J, Wanner L, Wismeijer D, Nelson K, Flugge T. A review of virtual planning software for guided implant surgery - data import and visualization, drill guide design and manufacturing. BMC Oral Health. 2020 Sep 10;20(1):251. doi: 10.1186/s12903-020-01208-1.
PubMed 32912273
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Accuracy in Fully Guided Dental Implant Surgery Using 3D-Printed Surgical Guides Without Metal Sleeves: A Split-Mouth In Vivo Study
- ClinicalTrials.gov ID
- NCT07364006
- Acronym / sponsor ID
- 24/764-E
- Conditions
- Edentulism
- Keywords
- Guided implant surgery, Dental implants, Surgical guide accuracy, Metal sleeve-free surgical guides, 3D-printed surgical guides
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 23 Jan 2026 (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 clinical trial aims to evaluate the in vivo accuracy of fully guided dental implant surgery using 3D-printed surgical guides without metal sleeves. The study is designed as a split-mouth clinical trial and will be conducted in partially or fully edentulous adult patients requiring complete-arch rehabilitation with dental implants.
The primary objective of the study is to assess the accuracy of implant placement by comparing the virtually planned implant positions with the actual clinical positions achieved after guided surgery. Accuracy will be evaluated by analyzing linear and angular deviations between planned and placed implants.
Participants will undergo a fully guided implant placement procedure using metal sleeve-free surgical guides. Two different drilling channel diameters (standard and reduced) will be randomly assigned in a split-mouth manner. Postoperative intraoral scans and cone-beam computed tomography (CBCT) scans with scan bodies will be obtained to register the final implant positions.
The planned and achieved implant positions will be compared using three-dimensional analysis software to quantify deviations and determine whether the use of metal sleeve-free guides and reduced drilling diameters influences implant placement accuracy.
Detailed description
Background. Computer-guided implant surgery is associated with a known loss of accuracy when compared with virtual implant planning, due to the influence of multiple clinical and technical factors. Deviations between planned and actual implant positions remain a relevant issue in guided implant surgery. Accuracy is commonly assessed by comparing virtually planned implant positions with postoperative implant positions using linear and angular deviation measurements. From a clinical perspective, improving the accuracy of guided implant placement is particularly relevant in complete-arch rehabilitations, where small deviations may affect prosthetic fit and clinical outcomes. Metal sleeves incorporated into surgical guides may contribute to mechanical tolerance between the drilling instrument and the guide, and reducing this tolerance could potentially improve accuracy.
Justification. Despite the widespread use of guided implant surgery, limited in vivo evidence exists regarding the effect of eliminating metal sleeves from surgical guides on implant placement accuracy. Additionally, the influence of reducing the drilling channel diameter on implant deviation relative to virtual planning has not been sufficiently evaluated. This study aims to determine whether the elimination of metal sleeves and the reduction of drilling channel diameter improve the accuracy of guided implant surgery. The findings may help clarify whether the use of metal sleeves is necessary and whether reducing the drilling channel diameter compared with manufacturer standards may decrease implant deviation by minimizing the gap between the drill and the guide.
Study Design. This study is designed as a prospective, single-center, interventional split-mouth clinical trial. An intraindividual comparison will be performed between two guided surgery conditions within the same patient.
Participants. The study population will consist of 15 partially or fully edentulous patients requiring fixed complete-arch rehabilitation with dental implants. Eligible participants will be patients classified as ASA I or II. Patients classified as ASA III or IV will be excluded. All participants will be required to meet the predefined inclusion criteria, none of the exclusion criteria, and will be required to provide written informed consent prior to participation.
Intervention. Virtual implant planning will be performed using guided surgery software by aligning DICOM data from cone-beam computed tomography scans with STL files of the maxillae obtained through intraoral scanning. A virtual diagnostic wax-up of the immediate-loading provisional restoration will be created to guide prosthetically driven implant planning. Following virtual planning, two drilling conditions will be randomly assigned in a split-mouth manner. On one side, drilling channels will be designed with the standard diameter recommended by the manufacturer for use with metal sleeves (4.85 mm). On the contralateral side, drilling channels will be designed with a reduced diameter of 4.83 mm. Surgical guides will be digitally designed, exported as STL files, and fabricated using three-dimensional printing technology with biocompatible surgical guide resin at a resolution of 35 microns. The guides will be sterilized in an autoclave at 134 °C for 5 minutes. Dental implants will be placed using the guided surgical templates.
Outcomes Assessment. After implant placement, postoperative intraoral scans with scan bodies will be obtained, and cone-beam computed tomography scans with scan bodies will be performed following a standardized imaging protocol. The planned and postoperative datasets will be compared to evaluate differences between virtual implant planning and actual implant placement. Measurements will be performed using reverse engineering software to calculate linear and angular deviations between planned and placed implants.
Statistical Analysis. Once data collection is completed, statistical analysis will be performed. Data normality will be assessed, and a chi-square test will be used to evaluate differences between the study conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Split-mouth design with intraindividual comparison of two drilling channel diameters using metal sleeve-free surgical guides.
| Arm | Type | Receives |
|---|---|---|
| Standard Drilling Diameter | Experimental | Device: Standard Drilling Channel Metal Sleeve-Free Surgical GuideImplant placement using metal sleeve-free 3D-printed surgical guides with a standard drilling channel diameter (4.85 mm). |
| Reduced Drilling Diameter | Experimental | Device: Reduced drilling channel Metal Sleeve-Free Surgical GuideImplant placement using metal sleeve-free 3D-printed surgical guides with a reduced drilling channel diameter (4.83 mm). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Partially or fully edentulous patients requiring fixed complete-arch rehabilitation with dental implants.
- Patients classified as ASA I or ASA II.
- Adult patients aged 18 years or older.
- Ability to understand the study procedures and provide written informed consent.
Key exclusion criteria (3 listed)
- Patients classified as ASA III or ASA IV.
- Patients with medical conditions that contraindicate dental implant surgery.
- Inability or unwillingness to provide informed consent.
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 |
|---|---|---|
| Standard Drilling Channel Metal Sleeve-Free Surgical GuideFully guided dental implant surgery performed using 3D-printed surgical guides without metal sleeves. The guides are designed based on virtual implant planning and used to place dental implants with a standard drilling channel diameter in a split-mouth design. | Device | Standard Drilling Diameter |
| Reduced drilling channel Metal Sleeve-Free Surgical GuideFully guided dental implant surgery performed using 3D-printed surgical guides without metal sleeves. The guides are designed based on virtual implant planning and used to place dental implants with reduced drilling channel diameter in a split-mouth design. | Device | Reduced Drilling Diameter |
Primary outcome
Effect of Drilling Channel Diameter on Implant Placement Accuracy
Time frame: Immediately after implant placement
Implant placement accuracy will be compared between implants placed using fully guided surgical guides with a standard drilling channel diameter (4.85 mm) and those placed using a reduced drilling channel diameter (4.83 mm). Linear deviations at the coronal and apical implant levels, as well as angular deviations of the implant axis, relative to the virtual implant planning will be measured to determine whether differences in accuracy exist between both drilling conditions.
1 secondary outcome
Deviation Between Planned and Actual Implant Positions
Time frame: Immediately after implant placement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Background: PubMed 34085497Gomez-Polo M, Ballesteros J, Padilla PP, Pulido PP, Revilla-Leon M, Ortega R. Merging intraoral scans and CBCT: a novel technique for improving the accuracy of 3D digital models for implant-supported complete-arch fixed dental prostheses. Int J Comput Dent. 2021 Jun 4;24(2):117-123.
- Background: PubMed 35499656Chen Z, Li J, Ceolin Meneghetti P, Galli M, Mendonca G, Wang HL. Does guided level (fully or partially) influence implant placement accuracy at post-extraction sockets and healed sites? An in vitro study. Clin Oral Investig. 2022 Aug;26(8):5449-5458. doi: 10.1007/s00784-022-04512-y. Epub 2022 May 2.
- Background: PubMed 33904640Pessoa R, Siqueira R, Li J, Saleh I, Meneghetti P, Bezerra F, Wang HL, Mendonca G. The Impact of Surgical Guide Fixation and Implant Location on Accuracy of Static Computer-Assisted Implant Surgery. J Prosthodont. 2022 Feb;31(2):155-164. doi: 10.1111/jopr.13371. Epub 2021 May 10.
- Background: PubMed 33583616Shah NP, Khanna A, Pai AR, Sheth VH, Raut SR. An evaluation of virtually planned and 3D-printed stereolithographic surgical guides from CBCT and digital scans: An in vitro study. J Prosthet Dent. 2022 Sep;128(3):436-442. doi: 10.1016/j.prosdent.2020.12.035. Epub 2021 Feb 12.
- Background: PubMed 30589502El Kholy K, Janner SFM, Schimmel M, Buser D. The influence of guided sleeve height, drilling distance, and drilling key length on the accuracy of static Computer-Assisted Implant Surgery. Clin Implant Dent Relat Res. 2019 Feb;21(1):101-107. doi: 10.1111/cid.12705. Epub 2018 Dec 27.
- Background: PubMed 36494239Hernandez-Margarit P, Palacios-Banuelos R, Roig M, Altuna P, Blasi A. Digital workflow for designing an interim implant-supported restoration with an optimal emergence profile in an open-source software program. J Prosthet Dent. 2024 Nov;132(5):857-862. doi: 10.1016/j.prosdent.2022.10.013. Epub 2022 Dec 6.
- Background: PubMed 31330566Derksen W, Wismeijer D, Flugge T, Hassan B, Tahmaseb A. The accuracy of computer-guided implant surgery with tooth-supported, digitally designed drill guides based on CBCT and intraoral scanning. A prospective cohort study. Clin Oral Implants Res. 2019 Oct;30(10):1005-1015. doi: 10.1111/clr.13514. Epub 2019 Sep 9.
- Background: PubMed 35257456Adams CR, Ammoun R, Deeb GR, Bencharit S. Influence of Metal Guide Sleeves on the Accuracy and Precision of Dental Implant Placement Using Guided Implant Surgery: An In Vitro Study. J Prosthodont. 2023 Jan;32(1):62-70. doi: 10.1111/jopr.13503. Epub 2022 Mar 22.
- Background: PubMed 32991643Abduo J, Lau D. Effect of Manufacturing Technique on the Accuracy of Surgical Guides for Static Computer-Aided Implant Surgery. Int J Oral Maxillofac Implants. 2020 Sep/Oct;35(5):931-938. doi: 10.11607/jomi.8186.
- Background: PubMed 32147893Henprasert P, Dawson DV, El-Kerdani T, Song X, Couso-Queiruga E, Holloway JA. Comparison of the Accuracy of Implant Position Using Surgical Guides Fabricated by Additive and Subtractive Techniques. J Prosthodont. 2020 Jul;29(6):534-541. doi: 10.1111/jopr.13161. Epub 2020 May 6.
- Background: PubMed 33504723Putra RH, Yoda N, Astuti ER, Sasaki K. The accuracy of implant placement with computer-guided surgery in partially edentulous patients and possible influencing factors: A systematic review and meta-analysis. J Prosthodont Res. 2022 Jan 11;66(1):29-39. doi: 10.2186/jpr.JPR_D_20_00184. Epub 2021 Jan 26.
- Background: PubMed 30685109Oh KC, Park JM, Shim JS, Kim JH, Kim JE, Kim JH. Assessment of metal sleeve-free 3D-printed implant surgical guides. Dent Mater. 2019 Mar;35(3):468-476. doi: 10.1016/j.dental.2019.01.001. Epub 2019 Jan 23.
- Individual participant dataSharing planned: Undecided
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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.
Solange J Vasquez Ramos, DDS, MSc contact
Juan Ballesteros, DDs, MSc principal investigator
Universidad Complutense de Madrid Juan Ballesteros- Martinez, DDs, MSc
Miguel A Gómez Polo, DDS, PhD study chair
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Drilling Channel Metal Sleeve-Free Surgical Guide and Reduced drilling channel Metal Sleeve-Free Surgical Guide in people with Edentulism, run by Universidad Complutense de Madrid 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 3 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: looking for participants now, as of the sponsor's last update on 23 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miguel A Gómez Polo, DDS, PhD (+34659390001, mgomezpo@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Drilling Channel Diameter on Implant Placement Accuracy (time frame: Immediately after implant placement). 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 NCT07364006, which also lists 13 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 Jan 2026.