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NCT Number: NCT06404385

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Valencia, 46010, Spain

About this study

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]).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

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

Treatment and study plan

Static computer-assisted guided surgery with analogic guide

Procedure

coDiagnostix9® planning software

Other names: Conventional laboratory surgical guide, gonyX®

Static computer-assisted guided surgery with CAD-CAM surgical guide

Procedure

coDiagnostix9® planning software

Other names: CAD-CAM surgical guide

Primary outcomes

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

    Time frame: 1 week post-operative

    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

  2. Accuracy in implants: angular deviation

    Time frame: 1 weel post-operatiive

    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.

Secondary outcomes

  1. Intraoperative complications

    Time frame: Intra-operative

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

  2. Postoperative complications

    Time frame: One month after implant placement

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

  3. Implant success

    Time frame: One year of implant loading

    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

  4. Peri-implant marginal bone loss

    Time frame: One year of implant loading

    Radiographic assessment of the marginal bone loss around the implants

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
May 8, 2024
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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