Evaluating bone loss around 30-day loaded dental implants
Evaluation of the Marginal Bone Level of Titanium Implants Produced by Additive Manufacture, in 30 and 90 Days: Randomized Within-subject Clinical Trial of 1-year Non-inferiority
This study is testing if dental implants made with 3D printing can be safely used after 30 days instead of waiting 90 days for people who have missing teeth in the back of their mouth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Sao Paulo Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (São Paulo) |
| Trial ID | NCT05627037 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the non-inferiority of dental implants produced by additive manufacturing when loaded after 30 days compared to those loaded after 90 days. The study will involve partially edentulous patients in the posterior mandible or maxilla, with each participant receiving two implants in the same arch. Over the course of one year, the trial will monitor changes in marginal bone levels and osseointegration success through scheduled follow-up visits at baseline, 30 days, 90 days, 6 months, and 1 year.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 70 in good general health requiring dental implants in the posterior mandible or maxilla.
Not a fit: Patients with uncontrolled diabetes, a history of chemotherapy, or those who smoke may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to faster loading times for dental implants without compromising bone health.
How similar studies have performed: Previous studies have shown promising results with similar approaches in dental implant loading times, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients treated and referred by the Dental Clinic of the School of Dentistry of the University of São Paulo; * Individuals over 18 years and under 70 years of age; * Good general health; * signed Informed Consent Form; * Need for rehabilitation with dental implants in areas of mandible or posterior maxilla (premolars and/or molars); * bacterial plaque index ≤ 20% (Silness \& Loe, 1964); * bleeding rate of ≤ 20% (Loe \& Silness, 1963); * Sufficient alveolar bone volume for an implant of: * Length: 8 or 10mm * Diameter: 3.5mm, 4. 00mm or 4. 5mm * Bone quality type I-III; * No associated bone regeneration. Exclusion Criteria: * Pregnant and lactating women; * Uncontrolled diabetes; * History of chemotherapy or radiotherapy in the last 5 years; * Radiotherapy in areas of the head and neck; * Use of immunosuppressants, bisphosphonate or prolonged use of corticosteroids; * Smokers; * Alcohol or drug abuse; * Untreated periodontitis; * History of previous bone increase in the implant installation region; * Presence of residual roots at the site receiving the implant; * Bone density type IV * Individuals with connective tissue disorders or metabolic diseases; * Postmenopausal osteoporosis or other systemic diseases that may affect bone metabolism; * Need for guided bone regeneration at the time of implant installation.
Where this trial is running
São Paulo
- School of Dentistry - University of São Paulo — São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Giuseppe A Romito, PhD — University of São Paulo, Brazil
- Study coordinator: Giuseppe A Romito, PhD
- Email: garomito@usp.br
- Phone: +5511 30917833
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.