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Not yet recruiting NCT06673563

A Clinical Study Collecting Patients' Experience During Dental Implant Treatment

— Observational Dental Implant Dental Restorations Patient Reported Outcome Patient Experience

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Dental Implant, Dental Restorations, Patient Reported Outcome, Patient Experience. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Development and Evaluation of a Patient-reported Experience Measure (PREM) in Implant Dentistry: an Exploratory Study

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.

Primary outcome measures

  • 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 outcome measures (7)
  • 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) [Time frame: Pre-Treatment, Baseline (Implant Insertion), Up to 6 months (Final Prosthesis Delivery), 1-Year Follow-Up]
  • Implant survival [Time frame: Up to 6 months (Final Prosthesis Delivery), 1-Year Follow-Up]
  • Prosthetic survival [Time frame: 1-Year Follow-Up Visit]
  • Keratinized Mucosa Status [Time frame: Up to 6 months (Final Prosthesis Delivery), 1-Year Follow-Up]
  • Gingival Index [Time frame: Up to 6 months (Final Prosthesis Delivery), 1-Year Follow-Up]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06673563 · 2023-1779

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗