Marginal Bone Level Around Titanium Implants Produced by Additive Manufacture

June 16, 2025 updated by: Giuseppe Alexandre Romito, University of Sao Paulo

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05508-900
        • School of Dentistry - University of São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Loading in 30 days
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
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
Device: 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
Active Comparator: Loading in 90 days
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
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
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant success rate
Time Frame: 1 year

The success rate or failure of each implant in clinical and radiographic findings will be classified using the success criteria defined by Buser et al. (1990)

  1. Absence of persistent subjective complaints, such as pain, foreign body sensation and/or dysesthesia.
  2. Absence of a recurrent peri-implant infection with suppuration.
  3. Absence of mobility.
  4. Absence of a continuous radiolucency around the implant.
  5. Possibility for restoration. These criteria will be monitored at 0 days (baseline), 30 days, 90 days, 6 months, and the final endpoint is one year
1 year
Modified Plaque Index (mPI)
Time Frame: 1 year

Modified Plaque Index (Mombelli, Van Oosten Et.Al 1987):

Scoring Criteria:

Score 0: No detection of plaque Score 1:Plaque only recognized by running a probe across the smooth marginal surface of the implant Score 2: Plaque can be seen by the naked eye. Score 3: Abundance of soft matter. The changes in Modified Plaque Index (mPI) will be monitored at 0 days (baseline), 30 days, 90 days, 6 months, and the final endpoint is one year
1 year
Modified Bleeding Index (mBI)
Time Frame: 1 year

Modified Sulcus Bleeding Index (Mombelli, Van Oosten Et.Al 1987):

Scoring Criteria:

Score 0: No bleeding when probe is passed along the gingival margin. Score 1: Isolated bleeding, spots present. Score 2: Blood forms a confluent red line on margins. Score 3: Heavy or profuse bleeding. The changes in Modified Bleeding Index (mBI) will be monitored by a blinded calibrated examiner at 0 days (baseline), 30 days, 90 days, 6 months, and the final endpoint is one year
1 year
Pocket probing depth (PPD)
Time Frame: 1 year
Pocket Probing Depth (PPD) will be measured by a blinded calibrated Examiner, and The changes in Pocket Probing Depth (PPD) will be monitored at 0 days (baseline), 30 days, 90 days, 6 months, and the final endpoint is one year
1 year
clinical attachment level (CAL)
Time Frame: 1 year
Clinical attachment level (CAL) will be measured by a blinded calibrated Examiner, and The changes in clinical attachment level (CAL) will be monitored at 0 days (baseline), 30 days, 90 days, 6 months, and the final endpoint is one year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Plenum (M3 Health Industria e Comercio de Produtos Médicos)

Investigators

  • Principal Investigator: Giuseppe A Romito, PhD, University of São Paulo, Brazil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2022

Primary Completion (Actual)

November 2, 2023

Study Completion (Estimated)

November 2, 2025

Study Registration Dates

First Submitted

October 31, 2022

First Submitted That Met QC Criteria

November 23, 2022

First Posted (Actual)

November 25, 2022

Study Record Updates

Last Update Posted (Actual)

June 19, 2025

Last Update Submitted That Met QC Criteria

June 16, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 59844422.4.0000.0075

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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