Marginal Bone Level Around Titanium Implants Produced by Additive Manufacture (NCT05627037) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Marginal Bone Level Around Titanium Implants Produced by Additive Manufacture
Brazil75 participantsStarted 2022-11-02
Plain-language summary
The aim of this study will be to evaluate the non-inferiority of implants produced by additive manufacture loaded in 30 days when compared with those loaded in 90 days, in relation to marginal bone loss, after 01 (one) year of follow-up
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.