Dental Implant, Dental Restorations, Patient Experience, Patient Reported Outcome
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Nobel Biocare
Dr Robert Bowe
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient reported experience at Pre-Treatment, Baseline (Implant Insertion) and Up to 6 months (Final Prosthesis Delivery) | Pre-Treatment, Baseline (Implant Insertion), Up to 6 months (Final Prosthesis Delivery) |
Secondary
| Measure | Time frame |
|---|---|
| OHIP-14 (summary score and separate questions) | Pre-Treatment, Baseline (Implant Insertion), Up to 6 months (Final Prosthesis Delivery), 1-Year Follow-Up |
| Patient satisfaction with esthetics and function (VAS) | Pre-Treatment, Baseline (Implant Insertion), Up to 6 months (Final Prosthesis Delivery), 1-Year Follow-Up |
| Implant survival | Up to 6 months (Final Prosthesis Delivery), 1-Year Follow-Up |
| Patient reported experience at 1-Year Follow-up | 1-Year Follow-Up |
| Keratinized Mucosa Status | Up to 6 months (Final Prosthesis Delivery), 1-Year Follow-Up |
| Gingival Index | Up to 6 months (Final Prosthesis Delivery), 1-Year Follow-Up |
| Prosthetic survival | 1-Year Follow-Up Visit |
Contacts
Primary ContactRobert Bowe
Outcome results
None listed