Incisors Single-Unit Rehabilitation With Narrow GM Implants

NCT05260892 | Unknown FDA Device

• 1 other identifier: CS.O.004
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

dental implants; oral rehabilitation; extra narrow implants

Outcome Measures

Primary Outcomes (1)

• Peri-implant bone level change

  Amount of peri-implant bone level change

  up to 36 months

Secondary Outcomes (7)

• Periimplant bone level

  up to 36 months

• Implant Survival

  up to 36 months

• Implant success

  up to 36 months

• Prosthetic Survival

  up to 36 months

• Prosthetic Success

  up to 36 months

Study Arms (1)

Narrow GM

Patients presenting at least onde edentulous site rehabilitated with Narrow GM implant

Device: Narrow GM implants

Interventions

Narrow GM implants DEVICE

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

Narrow GM

Eligibility Criteria

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

Study Population

Patients presenting 18 years of age or more, with at least one edentulous site in the region of lateral incisors in the maxilla and/or lateral and central incisors in the mandible, who are qualified for rehabilitation with narrow implants and single-unit fixed prostheses. Patients that give written informed consent to participate in this clinical study.

You may qualify if:

• Patients with 18 years of age or more
• At least one edentulous site in the region of lateral incisors in the maxilla and/or lateral and central incisors in the mandible
• Presence of natural adjacent and opposing tooth,
• Qualified for rehabilitation with narrow implants and single-unit fixed prostheses.

You may not qualify if:

• Signs of allergy or hypersensitivity to titanium
• Periodontal disease
• heavy smoking/alcohol drinking habits
• bruxism
• high use of bisphosphonate drugs or proton pump inhibitors (PPIs)
• radiation therapy
• diabetes
• autoimmune diseases
• uncontrolled systemic complications or diseases
• incomplete jawbone growth
• bleeding disorders
• HIV
• osteoporosis
• pregnancy.

Sponsors & Collaborators

• Neodent: lead

Study Sites (2)

Escola de Aperfeiçoamento Profissional dos Cirurgiões Dentistas de Goiás, EAPGOIAS.

Goiânia, Goiás, 74070-070, Brazil

RECRUITING

Universidade Federal de Uberlândia, Faculdade de Odontologia, Área de Oclusão Prótese Fixa e Materiais Odontológicos.

Uberlândia, Minas Gerais, 38408-100, Brazil

RECRUITING

Study Officials

• Waleska C Furquim, PhD

  Neodent

  STUDY DIRECTOR

Central Study Contacts

Roberta S Rocha, MSc

CONTACT

+55 41 2169-4000; roberta.rocha@neodent.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: March 2, 2022
• Study Start: October 1, 2022
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)