Marginal Bone Level Around Titanium Implants Produced by Additive Manufacture

University of Sao Paulo

Status

Active, not recruiting

Conditions

Dental Implants

Treatments

Device: Dental implant produced by additive manufacture

Study type

Interventional

Funder types

Other

Identifiers

NCT05627037

59844422.4.0000.0075

Details and patient eligibility

About

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

Full 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

Enrollment

75 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

75 participants in 2 patient groups

Loading in 30 days

Experimental group

Description:

Implant allocated to the study arm will be restored with a temporary restoration after 30 days of implant placement, that will be replaced with definitive restoration after 90 days of implant placement.

Treatment:

Device: Dental implant produced by additive manufacture

Loading in 90 days

Active Comparator group

Description:

Implant allocated to the study arm will be restored directly with the definitive restoration after 90 days of implant placement.

Treatment:

Device: Dental implant produced by additive manufacture