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

NCT06404385 | Completed

• 1 other identifier: H20190402125847
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dental Implant; Computer-assisted

Keywords

accuracy; computer-assisted surgery; computer-aided design; analogic; dental implants

Outcome Measures

Primary Outcomes (2)

• 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

  1 week post-operative

• 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.

  1 weel post-operatiive

Secondary Outcomes (4)

• Intraoperative complications

  Intra-operative

• Postoperative complications

  One month after implant placement

• Implant success

  One year of implant loading

• Peri-implant marginal bone loss

  One year of implant loading

Study Arms (2)

Conventional surgical guide

ACTIVE COMPARATOR

Implants (Straumann®) placed with an analogic laboratory surgical guide

Procedure: Static computer-assisted guided surgery with analogic guide

Computer aided design - computer aided manufacturing (CAD-CAM) surgical guide

EXPERIMENTAL

Implants (Straumann®) placed with static computer-assisted implant surgery

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

Interventions

Static computer-assisted guided surgery with analogic guide PROCEDURE

coDiagnostix9® planning software

Also known as: Conventional laboratory surgical guide, gonyX®

Conventional surgical guide

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

coDiagnostix9® planning software

Also known as: CAD-CAM surgical guide

Computer aided design - computer aided manufacturing (CAD-CAM) surgical guide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

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

Valencia, Valencia, 46010, Spain

Location

Related Publications (11)

• 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.

  PMID: 37099571 BACKGROUND

• 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.

  PMID: 28632253 BACKGROUND

• 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.

  PMID: 36716792 BACKGROUND

• 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.

  PMID: 31381178 BACKGROUND

• 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.

  PMID: 30589502 BACKGROUND

• 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.

  PMID: 34218450 BACKGROUND

• 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.

  PMID: 33359299 BACKGROUND

• 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.

  PMID: 36625374 BACKGROUND

• 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.

  PMID: 28363503 BACKGROUND

• 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.

  PMID: 33504723 BACKGROUND

• 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.

  PMID: 39578942 DERIVED

Study Officials

• MIGUEL PEÑARROCHA-DIAGO, Phd, DDS

  University of Valencia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: single-blind
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Stomatology

Model Details: A prospective, controlled, examiner- and statistician-blinded, parallel-arm quasi-experimental study

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 8, 2024
• Study Start: September 11, 2012
• Primary Completion: December 17, 2019
• Study Completion: December 17, 2019
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)