Neodent Implantable Devices of GM Line

NCT03812276 | Completed FDA Device

• 1 other identifier: CS.O.002
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 2

Brief Summary

Acqua GM (Grand Morse) Helix implants present an optimized implant design with adapted treatment protocol, allowing for treatment of patients with different bone qualities. The objective of the study is to prospectively collect clinical data to confirm the long-term safety and clinical performance of Acqua GM Helix implants and GM prosthetic abutments in daily dental practice setting, by means of 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 IFU (instructions for use). patients will be followed for 36 months after implant placement.

Conditions

Jaw, Edentulous; Jaw, Edentulous, Partially

Keywords

Dental Implants

Outcome Measures

Primary Outcomes (1)

• Implant survival and success rates

  Implant survival will be defined as no loss of the implant at each follow-up. Evaluation of implant success will be assessed based on the criteria proposed by Buser et al. (1990).

  36 months after implant placement

Secondary Outcomes (5)

• Implant survival and success rates

  6, 12 and 24 months after implant placement

• Prosthetic survival and success rates

  12, 24 and 36 months after implant placement

• Patient Satisfaction: OHIP-14 (Oral Health Impact Profile) questionnaire

  6, 12, 24 and 36 months after implant placement

• Clinician Satisfaction: VAS (Visual Analogue Scale) questionnaire

  Implant placement, 12, 24 and 36 months after implant placement

• Rate of adverse events related to the implant, prosthesis, surgery and oral health

  Implant placement, 6, 12, 24 and 36 months after implant placement

Study Arms (1)

Study Group

Neodent Acqua GM Helix 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

Patients 18 years of age or older who are in need of and who qualify for dental implant placement with GM Helix implants at the involved study centers. Patients that give written informed consent to participate in this clinical study.

You may qualify if:

• years of age or older;
• Need of one or more dental implants;
• Qualify for placement of Neodent GM Helix implants.

You may not qualify if:

• Signs of allergy or hypersensitivity to the chemical ingredients of the material: titanium alloy;
• Presence of acute inflammatory or infectious processes in live tissue;
• Unsuitable bone volume or quality;
• Serious medical problems (e.g. bone metabolism disorders, blood clotting disorders, unsuitable healing capacity);
• Insufficient oral hygiene;
• Incomplete jawbone growth;
• Patient uncooperative and not motivated;
• 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;
• Uncontrolled endocrinological diseases;
• Pregnancy.

Sponsors & Collaborators

• Neodent: lead

Study Sites (2)

Instituto Latino Americano de Pesquisa e Ensino Odontológico (ILAPEO)

Curitiba, Paraná, 80710-150, Brazil

Location

Universidade Positivo

Curitiba, Paraná, 81280-330, 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
• Target Duration: 36 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 23, 2019
• Study Start: February 14, 2019
• Primary Completion: January 10, 2023
• Study Completion: January 28, 2023
• Last Updated: February 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)