Clinical trial NCT05627037: Marginal Bone Level Around Titanium Implants Produced by Additive Manufacture
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Implants
Keywords: implant, osseointegration
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Plenum (M3 Health Industria e Comercio de Produtos Médicos)
First posted: 2022-11-25
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split-Mouth Study Model
Primary purpose: TREATMENT

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

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, 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 outcomes:
measure: Marginal Bone Loss (MBL)
timeFrame: 1 year
Secondary outcomes:
measure: Implant success rate
timeFrame: 1 year
measure: Modified Plaque Index (mPI)
timeFrame: 1 year
measure: Modified Bleeding Index (mBI)
timeFrame: 1 year
measure: Pocket probing depth (PPD)
timeFrame: 1 year
measure: clinical attachment level (CAL)
timeFrame: 1 year
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: School of Dentistry - University of São Paulo
Study officials:
affiliation: University of São Paulo, Brazil
name: Giuseppe A Romito, PhD
role: PRINCIPAL_INVESTIGATOR
References: