Neodent Implantable Devices of GM Line

NCT ID: NCT03812276

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-14
• Study Completion Date: 2023-01-28

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.

Detailed Description

The study protocol was reviewed and approved by an Ethics Committee (CE) in Brazil.

The sample will be prospectively and consecutively selected and will consist of patients who are 18 years of age or older, who are in need of one or more dental implants and who qualify for placement of Neodent GM Helix implants. Informed consent in writing will be obtained from each patient participating in the study prior to any study related procedure.

Neodent Acqua GM Helix implants will be placed under local anesthesia and with adequate bone bed preparation, as recommended by the manufacturer. Multiple implants may be placed in a single subject. Implants will be placed 2mm below the alveolar ridge.

The selection of the prosthetic component and loading protocol (late or immediate) will be conducted according to the need of each subject and to the manufacturer's instructions (IFU). Thus, implant immediate loading may be performed (at the discretion of the surgeon) when primary stability reach at least 32 N.cm and the patient present physiological occlusion.

Data concerning the studied variables will be collected by fulfilling the Case Report Form (CRF), in the following stages: First visit (Screening); T0 - Implant(s) placement; TL - Implant loading; T6, T12, T24 and T36 - 6, 12, 24 and 36 months, respectively, after implant placement. A visit window of more or less one month is eligible for each of the planned intervals.

Standardized digital periapical radiographs, computed tomography scans and photographs will be obtained in an usual daily practice frequency, as determined by the investigator.

Conditions

Jaw, Edentulous; Jaw, Edentulous, Partially

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Study Group

Neodent Acqua GM Helix dental implants will be placed. Multiple implants may be placed in a single subject.

Dental Implants

Intervention Type: 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).

Interventions

Dental Implants

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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Neodent

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Larissa Trojan, PhD

Role: STUDY_CHAIR

Neodent

Locations

Instituto Latino Americano de Pesquisa e Ensino Odontológico (ILAPEO)

Curitiba, Paraná, Brazil

Universidade Positivo

Curitiba, Paraná, Brazil

Countries

Brazil

Other Identifiers

CS.O.002

Identifier Type: -

Identifier Source: org_study_id