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Dental ImplantNCT06404385

Accuracy of Static Computer-assisted Implant Surgery in Distal Free-end Scenarios

A study testing Static computer-assisted guided surgery with analogic guide and Static computer-assisted guided surgery with CAD-CAM surgical guide in people with Dental Implant and Computer-assisted, run by University of Valencia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Technological advances have influenced the approach to implant treatment. One of the fields presently experiencing rapid development is static computer-assisted guided surgery (sCAIS), which allows transfer of the virtual implant planning to the mouth of the patient, based on the use of a surgical guide. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Dental Implant, Computer-assisted
What is being tested?
Static computer-assisted guided surgery with analogic guide and Static computer-assisted guided surgery with CAD-CAM surgical guide
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteSpain
Study dates
11 Sep 2012to 17 Dec 2019
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Indication of fixed prosthesis over at least two consecutive implants.
  • Sufficient residual crest for placing at least two implants 4.1 mm in diameter and 8 mm in length.
  • Mature bone and healthy soft tissues.
  • Implants placed via fully guided surgery.
  • Age > 18 years.
  • Good general health.
Show all 10Show fewer
  • Non-smokers or smokers of < 10 cigarettes/day (pipe smokers excluded).
  • Oral hygiene index < 3 and bleeding index < 25%.
  • Pre- and post- CBCT scan for analysis of accuracy.
  • Periapical radiographs at loading and after one year.

Who cannot join

  • Contraindications to implant therapy
  • Locations with acute infection.
  • Pregnant or nursing women.
  • Lack of follow-up.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • University of Valencia. Faculty of Medecine and Dentistry. CLINICA ODONTOLOGICA

    Valencia, Valencia, 46010

Other trials in Spain

About this study

Official title: Prospective Clinical Study on the Accuracy of Static Computer-assisted Implant Surgery in Patients Rehabilitated With Distal Free-end Implants. Conventional Versus CAD-CAM Surgical Guides

Technological advances have influenced the approach to implant treatment. One of the fields presently experiencing rapid development is static computer-assisted guided surgery (sCAIS), which allows transfer of the virtual implant planning to the mouth of the patient, based on the use of a surgical guide. In sCAIS there is a deviation between the virtually planned implant position and the actual position of the implant placed during surgery. A recent review analyzed only fully guided implants and recorded a mean coronal horizontal deviation (CHD) of 1.12 mm (standard deviation [SD] = 0.08), a mean apical horizontal deviation (AHD) of 1.41 mm (SD = 0.1), a mean vertical deviation (VD) of 0.12 mm (SD = 0.23), and a mean angular deviation (AD) of 3.58º (SD = 0.2).

The aim of the present study was to compare the accuracy of CAD-CAM and conventional guides in candidates for distal free-end implant treatment, and to analyze the effects of possible confounding factors inherent to the patient or the surgical technique employed.A prospective, controlled and blinded quasi-experimental study was carried out involving 27 patients with 76 implants distributed into two groups according to the surgical guide manufacturing approach used: conventional (control group [CG]) or CAD-CAM (test group [TG]). The implants were planned virtually with the planning software, and the surgical guides were manufactured. Fully guided implant placement was carried out, and the deviations were measured along with other secondary variables as potential confounding factors.

Read the detailed description

Planning of the implants is made in the ideal prosthetic position based on a previous CAD-CAM (computer aided design - computer aided manufacturing) wax-up. sCAIS facilitates correct prosthetic emergence and therefore contributes to secure optimum esthetic and biological outcomes, affording long-term stability of the soft and hard tissues.

These surgical guides can be manufactured using CAD-CAM or conventional technologies in the laboratory, employing drilling machines or mechanical positioners. In the case of the conventional guide manufactured in the laboratory, the technician creates a radiological guide that is then converted into a surgical guide - the whole process being analogic, except for planning of the implants. At present, and with the development of digital workflows, CAD-CAM procedures are used for both the design and manufacture of the surgical guide, using different processes. This simplifies the workflow, which can reduce the costs of smaller rehabilitations.

Clinical studies on accuracy published in the literature are heterogeneous, with differences in the systems used, the surgical technique, the type of surgical guide support or the type of edentulism involved.These data justify further research in humans, focusing on fully sCAIS, in order to reduce heterogeneity. Furthermore, a review of the literature revealed a lack of clinical publications on the accuracy of CAD-CAM surgical guides compared to conventional guides. Therefore, the aim of the present study was to compare the accuracy of CAD-CAM and conventional guides in candidates for distal free-end implant treatment, and to analyze the effects of possible confounding factors inherent to the patient or the surgical technique employed. Intra- and postoperative complications of the surgical technique were also evaluated, as well as implant success and peri-implant marginal bone loss. Hence, the null hypothesis of the study was the absence of any difference in accuracy between both guides.

A prospective, controlled, examiner- and statistician-blinded, parallel-arm quasi-experimental study was carried out at the University of Valencia (Valencia, Spain). Two groups were established according to the surgical guide design involved: conventional (control group [CG]) or CAD-CAM (test group [TG]).

Being tested
Static computer-assisted guided surgery with analogic guide, Static computer-assisted guided surgery with CAD-CAM surgical guide
Keywords
accuracy, computer-assisted surgery, computer-aided design, analogic, dental implants

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Static computer-assisted guided surgery with analogic guideProcedure or surgery

    Also called Conventional laboratory surgical guide, gonyX®

    coDiagnostix9® planning software

  • Static computer-assisted guided surgery with CAD-CAM surgical guideProcedure or surgery

    Also called CAD-CAM surgical guide

    coDiagnostix9® planning software

Study groups in NCT06404385
Study groupRoleWhat they receive
Conventional surgical guideActive comparatorImplants (Straumann®) placed with an analogic laboratory surgical guide
Receives: Procedure: Static computer-assisted guided surgery with analogic guide
Computer aided design - computer aided manufacturing (CAD-CAM) surgical guideExperimentalImplants (Straumann®) placed with static computer-assisted implant surgery
Receives: Procedure: Static computer-assisted guided surgery with CAD-CAM surgical guide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accuracy in implants: vertical, apical and coronal horizontal deviations

    New CBCT scans were obtained in all patients after implant placement . The coDiagnostix9® application was used to match the pre- and postoperative CBCT images and to compare the axis positions of the planned and placed implants. The vertical, apical and coronal horizontal deviations in millimeters (VD, AHD and CHD), were recorded between the long axis of the virtual planned and actual placed implant. Measured in millimeters

    Measured: 1 week post-operative

  2. Accuracy in implants: angular deviation

    New CBCT scans were obtained in all patients after implant placement . The coDiagnostix9® application was used to match the pre- and postoperative CBCT images and to compare the axis positions of the planned and placed implants. The angular deviation in degrees (AD), was recorded between the long axis of the virtual planned and actual placed implant. Measured in degrees.

    Measured: 1 weel post-operatiive

Secondary outcomes (4)

  1. Intraoperative complications

    Surgical guide fitting, retention, drill access, guide fracture, I

    Measured: Intra-operative

  2. Postoperative complications

    Infection, bleeding, edema, neurological alterations, pain, swelling

    Measured: One month after implant placement

  3. Implant success

    Success is defined as no permanent peri implant radiographic translucency, no sign of peri-implant infection with putrid secretion, absence of persistent pain, dysesthesia, and/or foreign-body feeling

    Measured: One year of implant loading

  4. Peri-implant marginal bone loss

    Radiographic assessment of the marginal bone loss around the implants

    Measured: One year of implant loading

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2024
  2. Study start11 Sep 2012
  3. Primary completion17 Dec 2019
  4. Study completion17 Dec 2019

Resources

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
Non-randomised
Intervention model
Parallel groups
Model description
A prospective, controlled, examiner- and statistician-blinded, parallel-arm quasi-experimental study
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06404385
Sponsor's protocol ID
H20190402125847
Status last verified
Aug 2025
First submitted
29 Apr 2024
Last updated
5 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Patients' personal data will not be published, however, the results of the scientific study will be published in a scientific dental journal.

Publications

  • Balaguer-Marti JC, Canet-Lopez A, Penarrocha-Diago M, Romeo-Rubio M, Penarrocha-Diago M, Garcia-Mira B. Influence of Splint Support on the Precision of Static Totally Guided Dental Implant Surgery: A Systematic Review and Network Meta-analysis. Int J Oral Maxillofac Implants. 2023 Jan-Feb;38(1):157-168. doi: 10.11607/jomi.9796.

    PubMed 37099571

  • Bover-Ramos F, Vina-Almunia J, Cervera-Ballester J, Penarrocha-Diago M, Garcia-Mira B. Accuracy of Implant Placement with Computer-Guided Surgery: A Systematic Review and Meta-Analysis Comparing Cadaver, Clinical, and In Vitro Studies. Int J Oral Maxillofac Implants. 2018 January/February;33(1):101-115. doi: 10.11607/jomi.5556. Epub 2017 Jun 20.

    PubMed 28632253

  • Chen X, Yang Z, Wang Y, Fu G. Fixation Pins Increase the Accuracy of Implant Surgery in Free-End Models: An In Vitro Study. J Oral Maxillofac Surg. 2023 May;81(5):593-601. doi: 10.1016/j.joms.2022.12.017. Epub 2023 Jan 28.

    PubMed 36716792

  • El Kholy K, Lazarin R, Janner SFM, Faerber K, Buser R, Buser D. Influence of surgical guide support and implant site location on accuracy of static Computer-Assisted Implant Surgery. Clin Oral Implants Res. 2019 Nov;30(11):1067-1075. doi: 10.1111/clr.13520. Epub 2019 Aug 20.

    PubMed 31381178

  • El 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 30589502

  • Kessler A, Le V, Folwaczny M. Influence of the tooth position, guided sleeve height, supporting length, manufacturing methods, and resin E-modulus on the in vitro accuracy of surgical implant guides in a free-end situation. Clin Oral Implants Res. 2021 Sep;32(9):1097-1104. doi: 10.1111/clr.13804. Epub 2021 Jul 17.

    PubMed 34218450

  • Khorsandi D, Fahimipour A, Abasian P, Saber SS, Seyedi M, Ghanavati S, Ahmad A, De Stephanis AA, Taghavinezhaddilami F, Leonova A, Mohammadinejad R, Shabani M, Mazzolai B, Mattoli V, Tay FR, Makvandi P. 3D and 4D printing in dentistry and maxillofacial surgery: Printing techniques, materials, and applications. Acta Biomater. 2021 Mar 1;122:26-49. doi: 10.1016/j.actbio.2020.12.044. Epub 2020 Dec 26.

    PubMed 33359299

  • Le V, Kessler A, Folwaczny M. Influence of DLP and SLA printer technology on the accuracy of surgical guides for implant dentistry in free-end situations. Int J Comput Dent. 2023 Sep 26;26(3):217-226. doi: 10.3290/j.ijcd.b3774115.

    PubMed 36625374

  • Matta RE, Bergauer B, Adler W, Wichmann M, Nickenig HJ. The impact of the fabrication method on the three-dimensional accuracy of an implant surgery template. J Craniomaxillofac Surg. 2017 Jun;45(6):804-808. doi: 10.1016/j.jcms.2017.02.015. Epub 2017 Feb 20.

    PubMed 28363503

  • Putra 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 33504723

  • Berta GM, Luigi C, Miguel PD, Carlos BJ. Prospective Clinical Study on the Accuracy of Static Computer-Assisted Implant Surgery in Patients With Distal Free-End Implants. Conventional Versus CAD-CAM Surgical Guides. Clin Oral Implants Res. 2025 Mar;36(3):314-324. doi: 10.1111/clr.14384. Epub 2024 Nov 23.

    PubMed 39578942

Questions about this trial

What is this clinical trial studying?

A study testing Static computer-assisted guided surgery with analogic guide and Static computer-assisted guided surgery with CAD-CAM surgical guide in people with Dental Implant and Computer-assisted, run by University of Valencia 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 10 inclusion and 4 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 5 Sep 2025. 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?

Accuracy in implants: vertical, apical and coronal horizontal deviations (time frame: 1 week post-operative). The study lists 2 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 NCT06404385, which also lists 11 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 5 Sep 2025.

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