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

August 29, 2025 updated by: Berta García Mira, University of Valencia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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]).

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Valencia
      • Valencia, Valencia, Spain, 46010
        • University of Valencia. Faculty of Medecine and Dentistry. CLINICA ODONTOLOGICA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional surgical guide
Implants (Straumann®) placed with an analogic laboratory surgical guide
Procedure: Static computer-assisted guided surgery with analogic guide
coDiagnostix9® planning software
Other Names:
  • Conventional laboratory surgical guide
  • gonyX®
Experimental: Computer aided design - computer aided manufacturing (CAD-CAM) surgical guide
Implants (Straumann®) placed with static computer-assisted implant surgery
Procedure: Static computer-assisted guided surgery with CAD-CAM surgical guide
coDiagnostix9® planning software
Other Names:
  • CAD-CAM surgical guide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 week post-operative
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.
1 weel post-operatiive

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative complications
Time Frame: Intra-operative
Surgical guide fitting, retention, drill access, guide fracture, I
Intra-operative
Postoperative complications
Time Frame: One month after implant placement
Infection, bleeding, edema, neurological alterations, pain, swelling
One month after implant placement
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
One year of implant loading
Peri-implant marginal bone loss
Time Frame: One year of implant loading
Radiographic assessment of the marginal bone loss around the implants
One year of implant loading

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Investigators

  • Study Director: MIGUEL PEÑARROCHA-DIAGO, Phd, DDS, University of Valencia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2012

Primary Completion (Actual)

December 17, 2019

Study Completion (Actual)

December 17, 2019

Study Registration Dates

First Submitted

April 29, 2024

First Submitted That Met QC Criteria

May 3, 2024

First Posted (Actual)

May 8, 2024

Study Record Updates

Last Update Posted (Estimated)

September 5, 2025

Last Update Submitted That Met QC Criteria

August 29, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H20190402125847

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patients' personal data will not be published, however, the results of the scientific study will be published in a scientific dental journal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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