Incisors Single-Unit Rehabilitation With Narrow GM Implants
NCT ID: NCT05260892
Last Updated: 2023-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
55 participants
OBSERVATIONAL
2022-10-01
2025-12-15
Brief Summary
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The objective of the study is to confirm the long-term safety and clinical performance of implants and abutments of the Narrow GM System in a daily dental practice setting, by means of a prospective collection of clinical data in an observational study using these devices.
Devices will be used according to standard routine in daily practice, according to all indications as specified by the manufacturer in the instructions for use (IFU).
55 patients (needed to obtain a sample size of 55 implants) will be followed for 36 months and monitored for Adverse Events by the Investigators until the last protocol-related procedure of a patient is completed.
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Detailed Description
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The Narrow GM Implants were designed for oral functional rehabilitation using dental implants, allowing for treatment of patients with different bone qualities in the region of lateral incisors in the maxilla or the region of lateral and central incisors in the mandible.
The objective of the study is to confirm the long-term safety and clinical performance of implants and abutments of the Narrow GM System in a daily dental practice setting, by means of a prospective collection of clinical data in an observational study using these devices. Additionally, from the collected data, the study aims to identify previously unknown side-effects and monitor the known side-effects and contraindications stated on the Instruction for Use (IFU), identify and analyze emerging risks on the basis of factual evidence and ensure the continued acceptability of the benefit-risk ratio with the intent to verify that the intended purpose is correct for all JJGC products involved in the procedure that get in contact with the patient.
The sample will be prospectively selected and will consist of 55 patients, with at least one edentulous site in the region of lateral incisors in the maxilla and/or lateral and central incisors in the mandible, presenting natural adjacent and opposing tooth, and who are qualified for rehabilitation with narrow implants and single-unit fixed prostheses. Informed consent in writing will be obtained from each patient participating in the study prior to any study-related procedure.
GM Narrow implants will be placed under local anesthesia by guided or conventional surgery - as chosen by the surgeon - and with adequate bone bed preparation, as recommended by the manufacturer. Multiple implants can be placed in the same patient, as indicated. Implants must be installed 2mm infra-bony.
Data concerning the studied variables will be collected following the procedures and assessments plan by fulfilling the Case Report Form (CRF), in the following stages: First visit (Screening); TP - Implants placement; T0 - Implant Loading; TF - final prosthesis T6, T12, T24 and T36 - 6, 12, 24 and 36 months, respectively, after implant loading.
Panoramic radiographs, periapical radiographs, and computed tomography (CT) scans will be obtained from the region of interest before surgery, for surgical planning. Additionally, standardized digital periapical radiographs will be taken in a usual daily practice frequency, as determined by the investigator: after implants placement (TP - immediately or within 1 week after implant placement) and during the post-operative stages (T0, TF, T6, T12, T24, and T36) to assess the osseointegration process, changes in peri-implant bone level as well as prosthetic settlement and integrity.
Moreover, soft tissue evaluation will be conducted at the pre-treatment (Screening visit), for the regions to be rehabilitated with the study implants and in the postoperative period, at T0, TF, T6, T12, T24, and T36, for all study implants.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Narrow GM
Patients presenting at least onde edentulous site rehabilitated with Narrow GM implant
Narrow GM implants
Rehabilitation of superior lateral incisors or inferior central and lateral incisors with narrow implants supporting single unit or partial prostheses
Interventions
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Narrow GM implants
Rehabilitation of superior lateral incisors or inferior central and lateral incisors with narrow implants supporting single unit or partial prostheses
Eligibility Criteria
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Inclusion Criteria
* At least one edentulous site in the region of lateral incisors in the maxilla and/or lateral and central incisors in the mandible
* Presence of natural adjacent and opposing tooth,
* Qualified for rehabilitation with narrow implants and single-unit fixed prostheses.
Exclusion Criteria
* Periodontal disease
* heavy smoking/alcohol drinking habits
* bruxism
* high use of bisphosphonate drugs or proton pump inhibitors (PPIs)
* radiation therapy
* diabetes
* autoimmune diseases
* uncontrolled systemic complications or diseases
* incomplete jawbone growth
* bleeding disorders
* HIV
* osteoporosis
* pregnancy.
18 Years
ALL
Yes
Sponsors
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Neodent
INDUSTRY
Responsible Party
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Principal Investigators
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Waleska C Furquim, PhD
Role: STUDY_DIRECTOR
Neodent
Locations
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Escola de Aperfeiçoamento Profissional dos Cirurgiões Dentistas de Goiás, EAPGOIAS.
Goiânia, Goiás, Brazil
Universidade Federal de Uberlândia, Faculdade de Odontologia, Área de Oclusão Prótese Fixa e Materiais Odontológicos.
Uberlândia, Minas Gerais, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CS.O.004
Identifier Type: -
Identifier Source: org_study_id
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