Accuracy of Static Guided Implant Surgery: 3D-printed vs Milled Surgical Guides

NCT06819995 | Recruiting

• 1 other identifier: 24/716-EC_X
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Dear Patient, You are invited to participate in a clinical study. To understand the study, please carefully review the following information. If you have any questions, feel free to ask the dentist leading the study. Dental implants are an effective, long-term solution for replacing missing teeth. They replace the root of a lost or unsalvageable tooth, supporting a crown or prosthesis to restore function and aesthetics. Proper placement is crucial for implants to function and last. Guided implant surgery is a technique that improves precision using customized surgical guides created from patient records, such as radiographs and scans. These guides act as templates to ensure accurate implant placement, optimizing functionality, aesthetics, and minimizing complications. There are two main methods for fabricating surgical guides: milling, which cuts material into shape, and 3D printing, which builds material layer by layer. This study aims to evaluate the differences in accuracy and long-term outcomes between implants placed using guides created by these two methods. Both clinical results (appearance and function) and radiographic results (bone integration) will be assessed to determine the best method for guide fabrication. You were selected for this study because you require dental implant rehabilitation. After clinical and radiographic evaluations, we determined you are a suitable candidate for implant placement to restore your dental function and aesthetics. If you choose to participate, the following steps will be taken:

• Anesthesia-related risks, such as allergic reactions, prolonged numbness, or local tissue damage.
• Surgical risks, including pain, swelling, bleeding, infection, temporary or permanent numbness, and damage to adjacent teeth or roots.
• Implant failure, either during initial bone integration or later, requiring additional treatment or replanning.
• Risks of material failure, such as fractures or loosening of prosthetic components. By participating, you will avoid costs for the implants, healing abutments, and surgical guides (approximate savings: €800-€1,200). However, you will be responsible for surgery (€60), prosthetic components (€250 each), and final restorations (€350 per crown). Participation also includes close monitoring of your implants for one year, allowing for early detection and management of complications at no cost. Participation is voluntary. If you decide not to participate, it will not affect your care. You may also withdraw from the study at any time without penalty, although clinical follow-ups are recommended to monitor your treatment outcomes. Your data will be handled anonymously and securely, in compliance with data protection laws (e.g., Spain's Organic Law 3/2018). Data will be used solely for research purposes and not for commercial gain. Identifiable information will not be published, and your rights to access, correct, or delete your data will be upheld. If you have questions, you may contact the research team by phone or email. You may also consult your dentist or the Ethics Committee. A copy of this document is available for your records. Thank you for considering participation in this study.

Conditions

Dental Implant; Guided Surgery Accuracy

Keywords

Dental implant; Guided surgery; Surgical guide; 3D printing; Milling

Outcome Measures

Primary Outcomes (1)

• Angular deviation

  The discrepancy between the planned and actual placed implants will be measured to determine the accuracy of implant placement by superimposition of the virtual plan for the implant position and the postoperative scan. Angular deviation will be reported in degrees and will be measured from the most coronal point of the implant shoulder to the implant apex. All measurements will be performed by the same researcher, and in cases of more than one implant placed on the same patient the measurements will be performed separately. Measurements will be obtained digitally.

  From planned implant position (presurgical digital plan) to final implant position (taken 3 months after implant placement, when performing the digital impression for the definitive crown)

Secondary Outcomes (22)

• Probing Depth (PD)

  From the loading visit, to 6 and 12 month follow-up visits

• Bleeding on Probing (BoP)

  From the loading visit, to 6 and 12 month follow-up visits

• Suppuration on Probing (SUP)

  From the loading visit, to 6 and 12 month follow-up visits

• Keratinized Mucosa Width (KMW)

  From the loading visit, to 6 and 12 month follow-up visits

• Implant survival

  6 and 12 month follow up visits

Study Arms (2)

3-D printed guide

ACTIVE COMPARATOR

Patients will receive guided dental implants by means of a 3D-printed static surgical guide.

Procedure: Static guided implant placement with a 3D printed guide

Milled guide

EXPERIMENTAL

Patients will receive guided dental implants by means of a milled static surgical guide.

Procedure: Static guided implant placement with a milled guide

Interventions

Static guided implant placement with a 3D printed guide PROCEDURE

3D-printed guides (E-Guide resin, EnvisionTEC®, Germany) (D4K Pro printer, EnvisionTEC®, Germany) performed by acommercial manufacturing center (Archimedes, Spain). All guides will be designed with guide sleeves. Finally, the guide will be post-processed and sterilized according to the manufacturer's recommendations.

Also known as: 3D-printed sCAIS

3-D printed guide

Static guided implant placement with a milled guide PROCEDURE

Milled guides (anaxCAM PMMA Clear blanks, Anaxdent, Germany) (CORiTEC 150i PRO miller, Imes-icore®, Germany). All guides will be designed with guide sleeves. Finally, the guide will be post-processed and sterilized according to the manufacturer's recommendations.

Also known as: Milled sCAIS

Milled guide

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients with one to four missing teeth, where dental implants are planned and where a tooth-supported or tooth-mucosal supported surgical guides can be fabricated. Free-ended situations will be allowed.
• Edentulous sites with at least 3 months of healing after tooth extraction.
• Staged hard and soft tissue augmentation will be permitted. In cases of previous bone augmentation (e.g. staged horizontal bone regeneration or lateral sinus lift), a minimum healing period of 6 months should be respected. In cases of previous soft tissue augmentation procedures, a minimum healing period of 2 months should be respected. Simultaneous close sinus lift procedures will be allowed when there is a minimum posterior bone height of 6 mm.
• Implants should be surrounded by at least 1.5 mm of bone.
• Periodontally healthy patients or with stable periodontal conditions after periodontal therapy. Periodontitis will be defined according to the EFP-AAP 2017 World Workshop Classification (Papapanou PN, Sanz M, et al., 2018): interdental CAL is detectable at ≥2 non-adjacent teeth or buccal or oral CAL ≥3 mm with pocketing ≥3 mm is detectable at ≥2 teeth, but the observed CAL cannot be ascribed to non-periodontitis-related causes such as 1) gingival recession of traumatic origin; 2) dental caries extending in the cervical area of the tooth; 3) the presence of CAL on the distal aspect of a second molar and associated with malposition or extraction of a third molar, 4) an endodontic lesion draining through the marginal periodontium; and 5) the occurrence of a vertical root fracture.
• Aged 21 years and over and able to sign an informed consent form.
• Enough available bone assessed on CBCT to place Klockner Vega implants of diameters ranging from 3.5 to 4.5 mm and lengths between 8 and 12 mm.

You may not qualify if:

• Systemic
• Completely edentulous patients or patients requiring mucosal- or bone-supported surgical guides.
• Compromised general health (ASA IV-VI patients).
• Systemic diseases which could influence the outcome of therapy (uncontrolled diabetes mellitus, bone disorders, etc.).
• Pregnant or nursing women.
• Chronic use of corticosteroids, nonsteroidal anti-inflammatory drugs (NSAID), or immune-modulator drugs (any type and dose).
• Patients who need medications that affect bone metabolism (bisphosphonates, any type and dose).
• Chronic diseases of the oral mucosa.
• Smokers of \>10 cigarettes/day.
• \>25% plaque index at the time of re-evaluation after non-surgical periodontal therapy and OHI
• Unable to attend all study visits.
• Need of simultaneous bone augmentation after implant placement to treat dehiscence and fenestration type defects or to augment bone contour (\<1.5 mm of bone all around the implant circumference).
• During surgery
• Lack of primary stability assessed by hand testing after implant placement.
• Less of 2 mm of keratinized mucosa, both at the lingual and buccal sites.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Klockner Implant System: collaborator

Study Sites (1)

Facultad de Odontología, Universidad Complutense de Madrid

Madrid, 28040, Spain

RECRUITING

Related Publications (15)

• Yi C, Li S, Wen A, Wang Y, Zhao Y, Zhang Y. Digital versus radiographic accuracy evaluation of guided implant surgery: an in vitro study. BMC Oral Health. 2022 Nov 24;22(1):540. doi: 10.1186/s12903-022-02585-5.

  PMID: 36424579 BACKGROUND

• Younes F, Cosyn J, De Bruyckere T, Cleymaet R, Bouckaert E, Eghbali A. A randomized controlled study on the accuracy of free-handed, pilot-drill guided and fully guided implant surgery in partially edentulous patients. J Clin Periodontol. 2018 Jun;45(6):721-732. doi: 10.1111/jcpe.12897. Epub 2018 May 10.

  PMID: 29608793 BACKGROUND

• Tang T, Liao L, Huang Z, Gu X, Zhang X. Accuracy of the evaluation of implant position using a completely digital registration method compared with a radiographic method. J Prosthet Dent. 2019 Dec;122(6):537-542. doi: 10.1016/j.prosdent.2018.11.020. Epub 2019 Apr 9.

  PMID: 30979434 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

• Lo Russo L, Guida L, Mariani P, Ronsivalle V, Gallo C, Cicciu M, Laino L. Effect of Fabrication Technology on the Accuracy of Surgical Guides for Dental-Implant Surgery. Bioengineering (Basel). 2023 Jul 24;10(7):875. doi: 10.3390/bioengineering10070875.

  PMID: 37508902 BACKGROUND

• Chai J, Liu X, Schweyen R, Setz J, Pan S, Liu J, Zhou Y. Accuracy of implant surgical guides fabricated using computer numerical control milling for edentulous jaws: a pilot clinical trial. BMC Oral Health. 2020 Oct 21;20(1):288. doi: 10.1186/s12903-020-01283-4.

  PMID: 33087073 BACKGROUND

• Frizzera F, Calazans NNN, Pascoal CH, Martins ME, Mendonca G. Flapless Guided Implant Surgeries Compared with Conventional Surgeries Performed by Nonexperienced Individuals: Randomized and Controlled Split-Mouth Clinical Trial. Int J Oral Maxillofac Implants. 2021 Jul-Aug;36(4):755-761. doi: 10.11607/jomi.8722.

  PMID: 34411217 BACKGROUND

• Abduo J, Lau D. Accuracy of static computer-assisted implant placement in anterior and posterior sites by clinicians new to implant dentistry: in vitro comparison of fully guided, pilot-guided, and freehand protocols. Int J Implant Dent. 2020 Mar 11;6(1):10. doi: 10.1186/s40729-020-0205-3.

  PMID: 32157478 BACKGROUND

• Magrin GL, Rafael SNF, Passoni BB, Magini RS, Benfatti CAM, Gruber R, Peruzzo DC. Clinical and tomographic comparison of dental implants placed by guided virtual surgery versus conventional technique: A split-mouth randomized clinical trial. J Clin Periodontol. 2020 Jan;47(1):120-128. doi: 10.1111/jcpe.13211. Epub 2019 Nov 14.

  PMID: 31628873 BACKGROUND

• Tattan M, Chambrone L, Gonzalez-Martin O, Avila-Ortiz G. Static computer-aided, partially guided, and free-handed implant placement: A systematic review and meta-analysis of randomized controlled trials. Clin Oral Implants Res. 2020 Oct;31(10):889-916. doi: 10.1111/clr.13635. Epub 2020 Jul 26.

  PMID: 32654230 BACKGROUND

• Schwarz F, Ramanauskaite A. It is all about peri-implant tissue health. Periodontol 2000. 2022 Feb;88(1):9-12. doi: 10.1111/prd.12407.

  PMID: 35103327 BACKGROUND

• Romandini M, Ruales-Carrera E, Sadilina S, Hammerle CHF, Sanz M. Minimal invasiveness at dental implant placement: A systematic review with meta-analyses on flapless fully guided surgery. Periodontol 2000. 2023 Feb;91(1):89-112. doi: 10.1111/prd.12440. Epub 2022 Jul 30.

  PMID: 35906928 BACKGROUND

• Papaspyridakos P, Chen CJ, Singh M, Weber HP, Gallucci GO. Success criteria in implant dentistry: a systematic review. J Dent Res. 2012 Mar;91(3):242-8. doi: 10.1177/0022034511431252. Epub 2011 Dec 8.

  PMID: 22157097 BACKGROUND

• Chackartchi T, Romanos GE, Parkanyi L, Schwarz F, Sculean A. Reducing errors in guided implant surgery to optimize treatment outcomes. Periodontol 2000. 2022 Feb;88(1):64-72. doi: 10.1111/prd.12411.

  PMID: 35103317 BACKGROUND

• Albrektsson T, Wennerberg A. On osseointegration in relation to implant surfaces. Clin Implant Dent Relat Res. 2019 Mar;21 Suppl 1:4-7. doi: 10.1111/cid.12742. Epub 2019 Feb 28.

  PMID: 30816639 BACKGROUND

Study Officials

• Mariano Sanz, DDS, PHD, DrHC

  Facultad de Odontología, Departamento de Especialidades Clínicas Odontológicas, Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ignacio Sanz-Sánchez, DDS, MSc, PHD

CONTACT

+ 34 ‭690845240‬; ignaciosanz@ucm.es

Juan Ernesto Del Rosal, DDS

CONTACT

‭+34 722 319 532‬; juanerde@ucm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Each patient will be randomized into the milled or 3D-printed group according to a balanced distribution system via a computer-generated table of random numbers. Allocation concealment will be kept during the surgery by means of opaque envelopes so that the patient is blinded, and it will be kept until the moment of data analysis by an independent researcher not involved in the execution of the clinical interventions. Opaque sealed envelopes will be opened at the milling center once the 3D implant planning has finished, been checked, and sent.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm, double-blind (examiner, and patient), single-center parallel randomized controlled trial

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: February 11, 2025
• Study Start: February 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 26, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)