A Clinical Study Collecting Patients' Experience During Dental Implant Treatment
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDr Robert Bowe
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial population
Patients in need of a dental implant treatment
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
99 Participants
are grouped into 3 trial groupsGroup A: Single tooth
Group B: Multiple teeth
Group C: Full-arch
Trial outcomes
Primary outcomes
1
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
1
Patient reported experience at 1-Year Follow-up
Time frame
1-Year Follow-Up2
OHIP-14 (summary score and separate questions)
Time frame
Pre-Treatment, Baseline (Implant Insertion), Up to 6 months (Final Prosthesis Delivery), 1-Year Follow-Up3
Patient satisfaction with esthetics and function (VAS)
Time frame
Pre-Treatment, Baseline (Implant Insertion), Up to 6 months (Final Prosthesis Delivery), 1-Year Follow-Up4
Implant survival
Time frame
Up to 6 months (Final Prosthesis Delivery), 1-Year Follow-UpLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: