Prospective Neodent® Zirconia System Study

NCT04545840 | Unknown

• 1 other identifier: CS.O.010
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The Neodent® Zirconia Implant is designed for the treatment of oral endosteal implantation for the functional and aesthetic rehabilitation, allowing for treatment of patients with different bone qualities. The objective of the study is to assess the success and survival rates of implantable devices of the Zirconia System, in order to confirm the long-term safety and clinical performance of implants and abutments of the Zirconia System in daily dental practice setting. Devices will be used according to standard routine in daily practice, according to manufacturer indications in the IFU. Patients will be followed for 36 months after implant placement.

Conditions

Jaw, Edentulous; Jaw, Edentulous, Partially

Keywords

Dental Implants; Mouth Rehabilitation

Outcome Measures

Primary Outcomes (2)

• Implant survival rate

  Implant survival will be defined as no loss of the implant.

  36 months after implant placement

• Implant success rate

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

  36 months after implant placement

Secondary Outcomes (7)

• Implant survival rate

  6 months after implant placement

• Implant success rate

  6 months after implant placement

• Prosthetic survival rate

  36 months after implant placement

• Prosthetic success rate

  36 months after implant placement

• Patient satisfaction: questionnaire

  At screening visit, after the temporary prosthesis period and 6, 12, 24 and 36 months after implant placement

Study Arms (1)

Study group

Zirconia Implants will be placed. More than one implant can be placed in the same patient, as long as the subject presents natural teeth adjacent to the implant site.

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

Patients 18 years of age or older who are in need of and who qualify for single dental implants placement in the posterior maxilla region with Neodent® Zirconia Implants. Patients that give written informed consent to participate in this clinical study.

You may qualify if:

• years of age or older;
• Maxillary posterior teeth missing, with adjacent natural teeth;
• Patient who are in need of oral rehabilitation with dental implants and single prostheses and qualify for placement of Zirconia Implants.

You may not qualify if:

• Subjects under 18 years of age, pregnant or breastfeeding women. And patients that present the device contraindications according to the IFU (instructions for use):
• Signs of allergy or hypersensitivity to the chemical ingredients of the material: Zirconia (Y-ZTP), Zirconium dioxide (ZrO2), Yttrium oxide (Y2O3), Hafnium dioxide (HfO2), Aluminum oxide (Al2O3);
• Acute inflammatory or infectious processes;
• Unsuitable bone volume or quality;
• Serious medical problems (e.g. bone metabolism disorders, blood clotting disorders, unsuitable healing capacity);
• Incomplete jawbone growth;
• Patient uncooperative and not motivated;
• Hypochondria;
• Alcoholism;
• Psychosis;
• Prolonged functional disorders which resist any treatment with medications;
• Xerostomia;
• Weakened immunological system;
• Diseases which require regular use of steroids;
• Uncontrolled endocrine diseases;

Sponsors & Collaborators

• Neodent: lead

Study Sites (1)

Instituto Latino Americano de Pesquisa e Ensino Odontológico (ILAPEO)

Curitiba, Paraná, 80710-150, Brazil

Location

MeSH Terms

Conditions

Jaw, Edentulous; Jaw, Edentulous, Partially

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: September 4, 2020
• First Posted: September 11, 2020
• Study Start: September 10, 2020
• Primary Completion: September 30, 2023
• Study Completion: December 30, 2024
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)