A Clinical Study Collecting Patients' Experience During Dental Implant Treatment

Dr Robert Bowe

Status: Not yet enrolling

Conditions: Dental Restorations; Patient Reported Outcome; Patient Experience; Dental Implant

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06673563

2023-1779

Details and patient eligibility

About

The study will gather data on patient reported experience (PREM) before, during and after dental implant treatment. Patients scheduled in three treatment groups for either single tooth, multiple teeth or full-arch dental rehabilitation are included in the study and will be treated according standard of care. Additionally, they are asked to report their experience based on pre-defined questionnaire assessing patient acceptance of implant treatment in dentistry. Patients will be followed-up until 1-Year post Final Prosthesis Delivery.

This studies primary endpoint is the completion of the PREM questionnaires. The study is not intended to investigate safety and performance of the used medical devices.

Enrollment: 99 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject signed informed consent
• Subject is at least 18 years old at the time of treatment
• Subject presented with the need of dental implant treatment for single tooth, multiple teeth, or full-arch rehabilitation
• Subject with medical and anatomical conditions that are in accordance with the applicable instructions for use (IFU)
• Subject agree to provide information on her/his experience and outcomes before, during and after the treatment
• Subject has a working e-mail address
• Subject has sufficient English language skills for answering the PREM questionnaires

Exclusion criteria

• Anatomical conditions discovered during surgery preventing the use of intended implant system
• Subject with history of allergy or adverse reactions to any materials used
• Uncontrolled unstable systemic disease
• Any ongoing application of medication that is interfering with the dental treatment
• Subject is not willing / unable to complete the PREM questionnaires
• Subject that is planning not to return to the investigational site for follow-up visits within study schedule
• Pregnant or lactating women at the time of implant insertion

Trial design

99 participants in 3 patient groups

Single tooth

Description:

Patient with the need of a single implant treatment

Multiple teeth

Description:

Patients in need of two or more dental implants

Full-arch

Description:

Patients in need of at least one All-on-4 treatment (with or without additional placed implants)