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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dental Implants
- Sponsor
- University of Sao Paulo
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Marginal Bone Loss (MBL)
- Status
- Active, not recruiting
- Last Updated
- 10 months ago
Overview
Brief 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
Detailed Description
This randomized Split-mouth clinical study of non-inferiority will monitor for one year partially edentulous patients in the posterior region of the mandible or maxilla, rehabilitated with 2 implants (AM) in the same Arch to evaluate the success rate of the implant, one loaded at 30 days after installation and the other at 90 days. Changes in marginal bone level and osseointegration success will be evaluated, with visits and data collection in 0 days (baseline), 30 days, 90 days, 6 months and 1 year
Investigators
Giuseppe Alexandre Romito
Professor
University of Sao Paulo
Eligibility 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,
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;
- •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
Outcomes
Primary Outcomes
Marginal Bone Loss (MBL)
Time Frame: 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.
Secondary Outcomes
- Implant success rate(1 year)
- Modified Bleeding Index (mBI)(1 year)
- Modified Plaque Index (mPI)(1 year)
- Pocket probing depth (PPD)(1 year)
- clinical attachment level (CAL)(1 year)