Clinical trial NCT03812276: Neodent Implantable Devices of GM Line
Official title: Prospective Observational Study of Neodent Implantable Devices of GM Line
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Jaw, Edentulous
Jaw, Edentulous, Partially
Keywords: Dental Implants
Lead sponsor: Neodent
Sponsor class: INDUSTRY
First posted: 2019-01-23
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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:

As exclusion criteria, solely the device contraindications according to the IFU (instructions for use) will be applied:

* 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.

Primary outcomes:
measure: Implant survival and success rates
timeFrame: 36 months after implant placement
Secondary outcomes:
measure: Implant survival and success rates
timeFrame: 6, 12 and 24 months after implant placement
measure: Prosthetic survival and success rates
timeFrame: 12, 24 and 36 months after implant placement
measure: Patient Satisfaction: OHIP-14 (Oral Health Impact Profile) questionnaire
timeFrame: 6, 12, 24 and 36 months after implant placement
measure: Clinician Satisfaction: VAS (Visual Analogue Scale) questionnaire
timeFrame: Implant placement, 12, 24 and 36 months after implant placement
measure: Rate of adverse events related to the implant, prosthesis, surgery and oral health
timeFrame: Implant placement, 6, 12, 24 and 36 months after implant placement
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: Instituto Latino Americano de Pesquisa e Ensino Odontológico (ILAPEO)
state: Paraná
city: Curitiba
country: Brazil
facility: Universidade Positivo
state: Paraná
Study officials:
affiliation: Neodent
name: Larissa Trojan, PhD
role: STUDY_CHAIR
References: