About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.).

Trial design

Design model

Parallel

Treatments tested in this trial

Static guided implant placement with a 3D printed guide
Procedure/Surgery
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.
Static guided implant placement with a milled guide
Procedure/Surgery
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.

Treatment groups

48 Participants

are divided into 2 treatment groups

Group A: 3-D printed guideActive comparator 1 intervention

Group B: Milled guideExperimental treatment 1 intervention

Trial outcomes

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.

Time frame

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

1

Probing Depth (PD)

This measurement will be performed using a UNC15 calibrated plastic probe (Colorvue™, HuFriedy®, Chicago, IL, USA) at 6 sites per implant by a calibrated examiner at loading and 6- and 12-months visits. Defined as the distance in mm between the bottom of the probeable pocket and the margin of the peri-implant mucosa.

Time frame

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

2

Bleeding on Probing (BoP)

This measurement will be performed using a UNC15 calibrated plastic probe (Colorvue™, HuFriedy®, Chicago, IL, USA) at 6 sites per implant by a calibrated examiner at loading and 6- and 12-months visits. Evaluated dichotomously as the presence or absence of bleeding within 15 seconds after gentle probing (about 20 g).

Time frame

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

3

Suppuration on Probing (SUP)

This measurement will be performed using a UNC15 calibrated plastic probe (Colorvue™, HuFriedy®, Chicago, IL, USA) at 6 sites per implant by a calibrated examiner at loading and 6- and 12-months visits. Evaluated dichotomously as the presence or absence of suppuration after probing.

Time frame

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

4

Keratinized Mucosa Width (KMW)

This measurement will be performed using a UNC15 calibrated plastic probe (Colorvue™, HuFriedy®, Chicago, IL, USA) at 6 sites per implant by a calibrated examiner at loading and 6- and 12-months visits. Measured as the distance in mm from the mid-buccal and mid-lingual mucosal margin to the mucosal junction.

Time frame

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

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts