Marginal Bone Level Around Titanium Implants Produced by Additive Manufacture

NCT05627037 | Active Not Recruiting DMC

• 1 other identifier: 59844422.4.0000.0075
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Conditions

Dental Implants

Keywords

implant, osseointegration

Outcome Measures

Primary Outcomes (1)

• Marginal Bone Loss (MBL)

  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.

  1 year

Secondary Outcomes (5)

• Implant success rate

  1 year

• Modified Plaque Index (mPI)

  1 year

• Modified Bleeding Index (mBI)

  1 year

• Pocket probing depth (PPD)

  1 year

• clinical attachment level (CAL)

  1 year

Study Arms (2)

Loading in 30 days

EXPERIMENTAL

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.

Device: Dental implant produced by additive manufacture

Loading in 90 days

ACTIVE COMPARATOR

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

Device: Dental implant produced by additive manufacture

Interventions

Dental implant produced by additive manufacture DEVICE

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

Loading in 30 days

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Plenum (M3 Health Industria e Comercio de Produtos Médicos): collaborator

Study Sites (1)

School of Dentistry - University of São Paulo

São Paulo, 05508-900, Brazil

Location

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Giuseppe A Romito, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: either the operator or the patient will be blinded for the primary outcome
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Split-Mouth Study Model

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 25, 2022
• Study Start: November 2, 2022
• Primary Completion: November 2, 2023
• Study Completion: November 2, 2025
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)