Clinical trial NCT06673563: A Clinical Study Collecting Patients' Experience During Dental Implant Treatment
Official title: Development and Evaluation of a Patient-reported Experience Measure (PREM) in Implant Dentistry: an Exploratory Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Dental Implant
Dental Restorations
Patient Reported Outcome
Patient Experience
Lead sponsor: Bowe Dental Clinic
Sponsor class: OTHER
Collaborators: name: Nobel Biocare
First posted: 2024-11-05
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in need of a dental implant treatment

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.


Eligibility criteria: 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

Primary outcomes:
measure: Patient reported experience at Pre-Treatment, Baseline (Implant Insertion) and Up to 6 months (Final Prosthesis Delivery)
timeFrame: Pre-Treatment, Baseline (Implant Insertion), Up to 6 months (Final Prosthesis Delivery)
Secondary outcomes:
measure: Patient reported experience at 1-Year Follow-up
timeFrame: 1-Year Follow-Up
measure: OHIP-14 (summary score and separate questions)
timeFrame: Pre-Treatment, Baseline (Implant Insertion), Up to 6 months (Final Prosthesis Delivery), 1-Year Follow-Up
measure: Patient satisfaction with esthetics and function (VAS)
timeFrame: Pre-Treatment, Baseline (Implant Insertion), Up to 6 months (Final Prosthesis Delivery), 1-Year Follow-Up
measure: Implant survival
timeFrame: Up to 6 months (Final Prosthesis Delivery), 1-Year Follow-Up
measure: Prosthetic survival
timeFrame: 1-Year Follow-Up Visit
measure: Keratinized Mucosa Status
timeFrame: Up to 6 months (Final Prosthesis Delivery), 1-Year Follow-Up
measure: Gingival Index
timeFrame: Up to 6 months (Final Prosthesis Delivery), 1-Year Follow-Up
Other outcomes:
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Study officials:
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