Description

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

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.

        As exclusion criteria, the contraindications, and warnings according to the Instructions
        for Use of the device will be applied, as follows:
          -  Signs of allergy or hypersensitivity to titanium
          -  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.