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Neodent Implantable Devices of GM Line

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03812276
Recruitment Status : Active, not recruiting
First Posted : January 23, 2019
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Neodent

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.


Condition or disease Intervention/treatment
Jaw, Edentulous Jaw, Edentulous, Partially Device: Dental Implants

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 43 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 36 Months
Official Title: Prospective Observational Study of Neodent Implantable Devices of GM Line
Actual Study Start Date : February 14, 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Group/Cohort Intervention/treatment
Study Group
Neodent Acqua GM Helix dental implants will be placed. Multiple implants may be placed in a single subject.
Device: 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).




Primary Outcome Measures :
  1. Implant survival and success rates [ Time Frame: 36 months after implant placement ]
    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).


Secondary Outcome Measures :
  1. Implant survival and success rates [ Time Frame: 6, 12 and 24 months after implant placement ]
    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).

  2. Prosthetic survival and success rates [ Time Frame: 12, 24 and 36 months after implant placement ]
    Prosthetic survival will be assessed as the prosthesis remaining in situ at each follow-up, irrespective of its condition. Success will be defined as the prosthesis that remained unchanged and did not require any intervention during the entire observational period.

  3. Patient Satisfaction: OHIP-14 (Oral Health Impact Profile) questionnaire [ Time Frame: 6, 12, 24 and 36 months after implant placement ]
    The Portuguese translation of OHIP-14 [18,19] questionnaire will be used to assess Oral Health Related Quality of Life (OHRQoL), as a measure of patient satisfaction with treatment. Scores will range from 0 (absence of negative impacts on oral health) to 28 (high frequency of negative impacts on oral health).

  4. Clinician Satisfaction: VAS (Visual Analogue Scale) questionnaire [ Time Frame: Implant placement, 12, 24 and 36 months after implant placement ]
    The assessment will be performed by means of a questionnaire using a visual analog scale (VAS) in the form of a 10 cm horizontal line, where 0 (left end) indicates minimum satisfaction and 10 (right end) indicates maximum satisfaction. The clinician will be instructed to mark the position considered to best represent their degree of general satisfaction with patient treatment. The score will be measured in centimeters from the left end of the line to the marked point.

  5. Rate of adverse events related to the implant, prosthesis, surgery and oral health [ Time Frame: Implant placement, 6, 12, 24 and 36 months after implant placement ]
    Determined by inquiring with the patient and clinical evaluation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03812276


Locations
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Brazil
Instituto Latino Americano de Pesquisa e Ensino Odontológico (ILAPEO)
Curitiba, Paraná, Brazil, 80710-150
Universidade Positivo
Curitiba, Paraná, Brazil, 81280-330
Sponsors and Collaborators
Neodent
Investigators
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Study Chair: Larissa Trojan, PhD Neodent
Additional Information:

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Responsible Party: Neodent
ClinicalTrials.gov Identifier: NCT03812276    
Other Study ID Numbers: CS.O.002
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Neodent:
Dental Implants
Additional relevant MeSH terms:
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Jaw, Edentulous
Jaw, Edentulous, Partially
Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Jaw Diseases
Musculoskeletal Diseases