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NCT Number: NCT05627037

Marginal Bone Level Around Titanium Implants Produced by Additive Manufacture

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dentistry - University of São Paulo

São Paulo, 05508-900, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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

  1. 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)

    • Absence of persistent subjective complaints, such as pain, foreign body sensation and/or dysesthesia.
    • Absence of a recurrent peri-implant infection with suppuration.
    • Absence of mobility.
    • Absence of a continuous radiolucency around the implant.
    • 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
  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Plenum (M3 Health Industria e Comercio de Produtos Médicos)

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Nov 25, 2022
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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