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Incisors Single-Unit Rehabilitation With Narrow GM Implants

NCT05260892 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2023-11-09

No results posted yet for this study

Summary

The Narrow GM Implants were designed for oral functional rehabilitation using dental implants, allowing for treatment of patients with different bone qualities in the region of lateral incisors in the maxilla or the region of lateral and central incisors in the mandible.

The objective of the study is to confirm the long-term safety and clinical performance of implants and abutments of the Narrow GM System in a daily dental practice setting, by means of a prospective collection of clinical data in an observational study using these devices.

Devices will be used according to standard routine in daily practice, according to all indications as specified by the manufacturer in the instructions for use (IFU).

55 patients (needed to obtain a sample size of 55 implants) will be followed for 36 months and monitored for Adverse Events by the Investigators until the last protocol-related procedure of a patient is completed.

Conditions

  • Edentulous Alveolar Ridge

Interventions

DEVICE

Narrow GM implants

Rehabilitation of superior lateral incisors or inferior central and lateral incisors with narrow implants supporting single unit or partial prostheses

Sponsors & Collaborators

  • Neodent

    lead INDUSTRY

Principal Investigators

  • Waleska C Furquim, PhD · Neodent

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2025-12-15
Completion
2025-12-15
FDA Device
Yes

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05260892 on ClinicalTrials.gov