Comparing hybrid and fully etched dental implants for stability
A Triple-blinded Non-inferiority Multicentre Randomized Controlled Trial Comparing Hybrid and Fully Etched Implants.Part 1. Implant Stability.
This study is testing whether hybrid dental implants are more stable than fully etched implants in patients who are missing some teeth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | University of Milan Academic / other |
| Locations | 1 site (Milan, MI) |
| Trial ID | NCT06100120 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the stability of hybrid dental implants compared to fully etched implants in partially edentulous patients. It is a randomized, triple-blinded, multicenter trial involving 128 participants who will receive either hybrid or fully etched implants. The primary outcome is to measure secondary stability using resonance frequency analysis two months after implant placement, with follow-up assessments for up to six months. The study will be conducted across 16 private practices, ensuring a rigorous and controlled environment for data collection.
Who should consider this trial
Good fit: Ideal candidates are partially edentulous patients over 20 years old who require at least one fixed partial denture supported by implants.
Not a fit: Patients who are pregnant, have uncontrolled systemic conditions, or are current smokers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of hybrid implants, potentially leading to improved dental implant options for patients.
How similar studies have performed: Previous studies have shown promising results in comparing different types of dental implants, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Partially edentulous patients who need at least one fixed partial denture supported by 1 or 2 implants; * Men and women over 20 years old; * Periodontally stable patients * Sufficient 3D bone availability * Ideal 3D implant placement: MD: minimum tooth-implant distance of 1.5 mm and minimum inter-implant distance of 3 mm; at least 1.5 mm of buccal plate thickness; the implants should be placed equicrestally or 1 mm subcrestally in such a way that the machined part remains completely submerged; the distance between the implant neck and the adjacent dentition should be less than 6mm; straight implants (0 to 20 degrees from the adjacent tooth long axis or 70 to 90 degrees from the ridge parallelism); Exclusion Criteria: * Pregnant or lactating women; * Uncontrolled systemic conditions; * Patients on drugs known to interfere with the bone metabolism; * Current smokers; * Simultaneous/staged regenerative procedures; * Immediate loading; * Immediate implants; * Short implants (\< 8 mm) or narrow implant (diameter \<3.3 mm);
Where this trial is running
Milan, MI
- Clinica Odontoiatrica IRCCS Ospedale Maggiore Policlinico — Milan, Mi, Italy (Recruiting)
Study contacts
- Principal investigator: Giulio Rasperini, DDS — University of Milan
- Study coordinator: Giulio Rasperini, DDS
- Email: giulio.rasperini@unimi.it
- Phone: +393358130194
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.