Using 3D printed root-shaped implants for immediate dental implantation
A Clinical Exploratory Study of Root Analogy Implant
NA · The Dental Hospital of Zhejiang University School of Medicine · NCT06449391
This study is testing if 3D printed dental implants that fit better can help people get their teeth replaced right away with fewer complications and better results.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 20 Years to 60 Years |
| Sex | All |
| Sponsor | The Dental Hospital of Zhejiang University School of Medicine (other) |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06449391 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of 3D printed personalized root-shaped implants for immediate dental implantation, aiming to address complications arising from traditional implants that do not fit well with extraction sockets. The study utilizes laser melting printing technology to create titanium implants that are designed to enhance osseointegration and reduce surgical time. Participants will undergo immediate implantation procedures, with the goal of improving outcomes such as reduced waiting times and better aesthetic results. The research is backed by previous studies demonstrating the implants' effectiveness in animal models.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20-60 with good oral hygiene and specific dental conditions suitable for immediate implantation.
Not a fit: Patients with moderate to severe periodontitis or missing adjacent teeth in the target area may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the efficiency and outcomes of immediate dental implant procedures for patients.
How similar studies have performed: Previous studies have shown promising results with similar 3D printed implant technologies, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age:20-60 years old, gender unlimited * Good oral hygiene * No systemic diseases * There are irreparable residual roots, no obvious apical periodontitis, no looseness greater than degree II, and the tooth position includes four quadrant anterior teeth and premolars * Root length greater than 10 mm, and no significant bone resorption at the alveolar crest * There is no significant displacement of adjacent teeth and no significant elongation of opposing teeth * The bone density of the target implant area is Class II and Class III * The lateral bone wall of the lips (cheeks), palate (tongue) is intact and larger than 1mm * The subjects are able to understand the purpose of the experiment, willing to -cooperate with surgical treatment and follow-up, voluntarily participate in the experiment, and sign an informed consent form. Exclusion Criteria: * Patients with moderate to severe periodontitis * Missing proximal and distal adjacent teeth in the target residual root * Residual roots with root adhesion * The target implant area has a bone density of Class I or IV * Acute infectious disease or metabolic bone disease activity period * Patients with diabetes history and poor blood glucose control (fasting blood glucose ≥ 8.8 mmol/L L) * Patients with liver and kidney dysfunction (AST, ALT ≥ 1.5 times ULNULN, creatinine ≥ 1.5 times ULNULN) * Individuals with a history of osteoporosis * Individuals with a history of malignant tumors or other serious illnesses who are not suitable for surgery * Individuals with mental disorders and lack of autonomous behavior ability Pregnant women, lactating or menstruating women, and women with pregnancy plans within six months * Various possible causes of imaging artifacts in the surgical area * Receiving medication that may affect bone metabolism (such as bisphosphonates) within the past 3 months * The researchers estimate poor compliance or other factors that are not suitable for conducting this experiment.
Where this trial is running
Hangzhou, Zhejiang
- The Affiliated Stomatology Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (RECRUITING)
Study contacts
- Study coordinator: Yixu Chen
- Email: 11818293@zju.edu.cn
- Phone: +86 571 8721 9287
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dental Implantation, Dental Implants, Osseointegration, root analogy implant, Immediate implantation