Study of Neodent Implantable Devices of GM Zygomatic Line

NCT04328116 | Unknown FDA Device

• 1 other identifier: CS.O.008
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

GM Zygomatic implant is intended to be surgically placed in the posterior region of the maxilla and zygoma. It is indicated for multiple prostheses in case of severe resorption in the maxilla and total edentulism (situations in which the installation of convectional implants is contraindicated). The objective of the study is to confirm the long-term safety and clinical performance of GM Zygomatic implants and GM Zygomatic abutments in daily dental practice setting, by means of a prospective collection of clinical data concerning the success and survival rates of 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). Ten patients 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

Jaw, Edentulous

Keywords

Dental Implants; Zygomatic Implants

Outcome Measures

Primary Outcomes (2)

• Implant survival rate

  Implant survival will be defined as no loss of the implant at each follow-up.

  36 months after implant placement.

• Implant success rate

  Evaluation of implant success will be assessed based on the criteria by Byser et al (1990).

  36 months after implant placement.

Secondary Outcomes (10)

• Implant survival rate

  6, 12, and 24 months after implant placement.

• Implant success rate

  6, 12, and 24 months after implant placement.

• Prosthetic survival rate

  12, 24, and 36 months after implant placement.

• Prosthetic success rate

  12, 24, and 36 months after implant placement.

• Patient Satisfaction

  Before implant placement and 6, 12, 24, and 36 months after implant placement.

Study Arms (1)

Study Group

Neodent GM Zygomatic Dental Implants will be placed. Multiple implants may be placed in a single subject.

Device: Dental Implants

Interventions

Dental Implants DEVICE

Dental Implants will be used according to standard routine in daily practice, according to all indications as specified by the manufacturer in the IFU (informations for use)

Study Group

Eligibility Criteria

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

Study Population

The sample will be prospectively selected and will consist of 10 patients with atrophic edentulous maxillae, for whom the responsible surgeon elects the rehabilitation by means of placement of zygomatic implants as having the best risk-benefit ratio for the patient (e.g., shorter treatment time and lower biological cost than the associated with reconstructive surgeries for the insertion of conventional implants).

You may qualify if:

• years of age or more;
• Opposing dentition (natural teeth or teeth/implant-supported fixed restorations).

You may not qualify if:

• Symptomatology related to the facial sinuses (maxillary sinusitis, polyps or any other sinus pathologies);
• Unfavorable maxillary relations;
• Signs of allergy or hypersensitivity to the chemical ingredients of the material: titanium;
• Presence of acute inflammatory or infectious processes in live tissue;
• Unsuitable bone volume and/or quality;
• Systemic complications or diseases such as bone metabolism disorders, blood clotting disorders, unsuitable healing capacity, incomplete jawbone growth, uncooperative and not motivated patient, abuse of drugs or alcohol, psychosis, prolonged functional disorders which resist any treatment with medications, xerostomia, weakened immunological system, diseases which require the use of steroids, endocrine diseases, insufficient oral hygiene, and pregnancy.
• Additionally, subjects will be excluded if they present systemic complications that may expose them to an eventual surgical risk if submitted to surgery under general anesthesia or under local anesthesia and sedation (decompensated diabetics, immunosuppressed, patients who were submitted to radiotherapy and chemotherapy less than 4 years or who had a heart attack less than 1 year previously, patients with clinical signs and/or symptoms of sinusitis and congestion and/or nasal secretion.

Sponsors & Collaborators

• Neodent: lead

Study Sites (1)

Instituto Latino Americano de Pesquisa e Ensino Odontológico

Curitiba, Paraná, 80710-150, Brazil

Location

MeSH Terms

Conditions

Jaw, Edentulous

Interventions

Dental Implants

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Larissa Trojan, PhD

  Neodent

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 31, 2020
• Study Start: July 15, 2020
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)