A Clinical Study Collecting Patients' Experience During Dental Implant Treatment

N/ANot Yet RecruitingNCT06673563

Dr Robert Bowe99 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Dental Implant Dental Restorations Patient Reported Outcome Patient Experience

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Patient reported experience at Pre-Treatment, Baseline (Implant Insertion) and Up to 6 months (Final Prosthesis Delivery)

Time frame: Pre-Treatment, Baseline (Implant Insertion), Up to 6 months (Final Prosthesis Delivery)

Secondary Outcomes

Patient reported experience at 1-Year Follow-up

Time frame: 1-Year Follow-Up

OHIP-14 (summary score and separate questions)

Time frame: Pre-Treatment, Baseline (Implant Insertion), Up to 6 months (Final Prosthesis Delivery), 1-Year Follow-Up

Patient satisfaction with esthetics and function (VAS)