Clinical trial NCT05260892: Incisors Single-Unit Rehabilitation With Narrow GM Implants
Official title: Incisors Single-Unit Rehabilitation With Narrow GM Implants: Observational Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Edentulous Alveolar Ridge
Keywords: dental implants
oral rehabilitation
extra narrow implants
Lead sponsor: Neodent
Sponsor class: INDUSTRY
First posted: 2022-03-02
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting 18 years of age or more, with at least one edentulous site in the region of lateral incisors in the maxilla and/or lateral and central incisors in the mandible, who are qualified for rehabilitation with narrow implants and single-unit fixed prostheses.

Patients that give written informed consent to participate in this clinical study.

Brief summary: 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.

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Patients with 18 years of age or more
* 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:

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.

Primary outcomes:
measure: Peri-implant bone level change
timeFrame: up to 36 months
Secondary outcomes:
measure: Periimplant bone level
timeFrame: up to 36 months
measure: Implant Survival
timeFrame: up to 36 months
measure: Implant success
timeFrame: up to 36 months
measure: Prosthetic Survival
timeFrame: up to 36 months
measure: Prosthetic Success
timeFrame: up to 36 months
measure: Patient Satisfaction with treatment: questionnaire
timeFrame: up to 36 months
measure: Clinician Satisfaction with treatment: questionnaire
timeFrame: up to 36 months
Other outcomes:
Locations:
city: Goiânia
country: Brazil
facility: Escola de Aperfeiçoamento Profissional dos Cirurgiões Dentistas de Goiás, EAPGOIAS.
state: Goiás
city: Uberlândia
country: Brazil
facility: Universidade Federal de Uberlândia, Faculdade de Odontologia, Área de Oclusão Prótese Fixa e Materiais Odontológicos.
state: Minas Gerais
Study officials:
affiliation: Neodent
name: Waleska C Furquim, PhD
role: STUDY_DIRECTOR
References: