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

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:

1. A thorough examination of your dental health, including radiographs and photographs.
2. Planning and guided surgery performed at the Postgraduate Program in Periodontics.
3. Random assignment to receive either a 3D-printed or milled surgical guide. This assignment will be computer-generated and remain unknown until the study concludes.
4. Surgery under local anesthesia, lasting 1-2 hours, followed by suture removal after 7 days and follow-ups at 2 and 3 weeks to monitor healing.
5. At 3 months, clinical and radiographic evaluations will be performed, and digital impressions will be taken to assess differences between planned and final implant positions. The impressions will also be used to fabricate your final prosthesis, which will be placed approximately one month later.
6. Follow-ups at 6 and 12 months after prosthesis placement will assess implant stability and overall outcomes. The study will conclude after this final evaluation.

Participation involves certain risks:

* 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

Interventions

PROCEDURE

Static guided implant placement with a 3D printed guide

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.

PROCEDURE

Static guided implant placement with a milled guide

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.

Sponsors & Collaborators

• Klockner Implant System

  collaborator UNKNOWN

• Universidad Complutense de Madrid

  lead OTHER

Principal Investigators

• Mariano Sanz, DDS, PHD, DrHC · Facultad de Odontología, Departamento de Especialidades Clínicas Odontológicas, Universidad Complutense de Madrid

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-15

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• Spain

Study Locations