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RECRUITING

NCT06819995

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

Sponsor: Universidad Complutense de Madrid

View on ClinicalTrials.gov

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.

Official title: Accuracy of Static Guided Implant Surgery: 3D-printed vs Milled Surgical Guides, a Randomized Clinical Trial

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-02-15

Completion Date

2026-12-31

Last Updated

2025-03-26

Healthy Volunteers

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.

Inclusion Criteria: * 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. Exclusion Criteria: 1. 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). 2. 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. * Lack of guide adjustment verified through the fitting windows.

Locations (1)

Facultad de Odontología, Universidad Complutense de Madrid

Madrid, Spain