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NCT Number: NCT06576284

A 36-month Analysis of the Clinical Performance of Individualized CAD/CAM-produced Dental Implants: a Cohort Study

The goal of this prospective cohort study is to evaluate the clinical performance of a new generation of customized CAD/CAM pre-fabricated root-analog dental implants over a 36-month period. The main questions it aims to answer are:

1. Are these novel implants safe, effective, and clinically viable for 36 months? 2. Do these drilling-free implants result in better post-operative outcomes compared to traditional implant techniques? Twelve patients receiving these customized implants immediately after tooth extraction will undergo clinical and radiographic examinations at 12, 24, and 36 months after prosthesis installation. The study will assess peri-implant tissue health, post-operative comfort, bone preservation, tissue integration, and implant survival rates.

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Key information

Conditions

Tooth Loss Dental Implant Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Received a personalized dental implant using the iDENTICAL Dental Implant System during the previous interventional phase;
  • Completed the 12-month follow-up period after implant placement in the previous interventional phase;
  • Available for follow-up evaluations during the 36 months of the observational study.

Exclusion criteria

  • Occurrence of serious complications (implant loss, infection, etc.) during the previous interventional phase;
  • Development of uncontrolled medical conditions during the follow-up period;
  • Inability to attend scheduled follow-up visits;
  • Refusal to participate in the observational study.

Treatment and study plan

Primary outcomes

  1. Radiographic success

    Time frame: 12 months, 24 months and 36 months

    Radiographic success, defined as the absence of peri-implant radiolucency and lack of progressive loss (> 1.7 mm) of marginal bone level (MBL) over the 36 months following implant restoration.

Secondary outcomes

  1. Linear horizontal changes of peri-implant soft tissues

    Time frame: 12 months, 24 months and 36 months

    measured from intraoral scans at 1mm, 3mm, and 5mm below the reference gingival margin level at the time of crown placement, at 12, 24, and 36 months.

  2. Prosthetic Level outomes

    Time frame: 12 months, 24 months and 36 months

    Chipping/fracture of material; Loss of retention of restoration (cementation cement fracture); Connector (Abutment) fracture; Loss/failure of restoration substrate requiring new restoration; The restoration functions as intended/satisfactorily for the subject

  3. Peri-implant clinical parameters

    Time frame: 12 months, 24 months and 36 months

    Mobility (MOB)

Study contacts

Contact information is provided by the study sponsor or research team.

Cristina C Villar

CONTACT

[email protected]

(11)968403872 ext. +55

Romito

CONTACT

[email protected]

(11) 992051939 ext. +55

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 28, 2024
Registry last updated
Nov 20, 2024

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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