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NCT Number: NCT06673563

A Clinical Study Collecting Patients' Experience During Dental Implant Treatment

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.

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Key information

Conditions

Dental Implant Dental Restorations Patient Experience Patient Reported Outcome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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-Up

  2. 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

  3. 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

  4. Implant survival

    Time frame: Up to 6 months (Final Prosthesis Delivery), 1-Year Follow-Up

  5. Prosthetic survival

    Time frame: 1-Year Follow-Up Visit

  6. Keratinized Mucosa Status

    Time frame: Up to 6 months (Final Prosthesis Delivery), 1-Year Follow-Up

  7. Gingival Index

    Time frame: Up to 6 months (Final Prosthesis Delivery), 1-Year Follow-Up

Study contacts

Contact information is provided by the study sponsor or research team.

Robert Bowe

CONTACT

[email protected]

+353 61 608 186

Sponsors and collaborators

Lead sponsor

Dr Robert Bowe

Other

Collaborators

  • Nobel Biocare

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Nov 5, 2024
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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