Dental implant produced by additive manufactureDental implant produced by additive manufacture
Dental implant produced by additive manufacture: In a split-mouth setup, each participant will receive two implants in the posterior region of the mandible or maxilla. After implant insertion, one implant will be randomly allocated to receive Temporary restoration after 30 days and definitive restoration after 90 days
Dental implant produced by additive manufacture: In a split-mouth setup, each participant will receive two implants in the posterior region of the mandible or maxilla. After implant insertion, one implant will receive definitive restoration after 90 days
Study 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
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Marginal Bone Loss (MBL) — 1 year Digital periapical radiographs will be taken at the implant installation (baseline) after 1 year. The radiographs will be taken using the parallelism technique with a positioner that supports the digital sensor in order to standardize the radiographs.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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