Rehabilitation of missing teeth using narrow dental implants
Incisors Single-Unit Rehabilitation With Narrow GM Implants: Observational Prospective Study
This study is testing how safe and effective narrow dental implants are for people who need to replace missing teeth in their upper or lower jaws over a period of three years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 55 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Neodent Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 2 sites (Goiânia, Goiás and 1 other locations) |
| Trial ID | NCT05260892 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the long-term safety and clinical performance of Narrow GM Implants for oral rehabilitation in patients with edentulous sites in the maxilla and mandible. A total of 55 patients will be monitored over 36 months to collect clinical data and assess any adverse events associated with the implants. The study will follow standard practices as outlined by the manufacturer, ensuring that the implants are used appropriately in daily dental practice. The goal is to confirm the implants' effectiveness and identify any potential risks or side effects.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with at least one missing tooth in the specified regions of the mouth and who are suitable for narrow implants.
Not a fit: Patients with contraindications such as uncontrolled systemic diseases, allergies to titanium, or those undergoing certain medical treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance dental rehabilitation options for patients with missing teeth, improving their oral function and quality of life.
How similar studies have performed: While similar studies have explored the use of dental implants, this specific approach with Narrow GM Implants is relatively novel and aims to gather new data on their safety and performance.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Goiânia, Goiás and 1 other locations
- Escola de Aperfeiçoamento Profissional dos Cirurgiões Dentistas de Goiás, EAPGOIAS. — Goiânia, Goiás, Brazil (Recruiting)
- Universidade Federal de Uberlândia, Faculdade de Odontologia, Área de Oclusão Prótese Fixa e Materiais Odontológicos. — Uberlândia, Minas Gerais, Brazil (Recruiting)
Study contacts
- Study coordinator: Roberta S Rocha, MSc
- Email: roberta.rocha@neodent.com
- Phone: +55 41 2169-4000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.