A Clinical Study Collecting Patients' Experience During Dental Implant Treatment

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Implant; Dental Restorations; Patient Experience; Patient Reported Outcome

• Study Type: Observational
• Enrollment (Estimated): 99

Contacts and Locations

• Study Contact: Name: Robert Bowe; Phone Number: +353 61 608 186; Email: rob@bowedentalclinic.ie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients in need of a dental implant treatment

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Single tooth; Patient with the need of a single implant treatment
Multiple teeth; Patients in need of two or more dental implants
Full-arch; Patients in need of at least one All-on-4 treatment (with or without additional placed implants)

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Patient reported experience at 1-Year Follow-up	1-Year Follow-Up
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
Prosthetic survival	1-Year Follow-Up Visit
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

Collaborators and Investigators

• Sponsor: Dr Robert Bowe
• Collaborators: Nobel Biocare

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: November 2, 2024
• First Posted (Estimated): November 5, 2024

Study Record Updates

• Last Update Posted (Estimated): November 5, 2024
• Last Update Submitted That Met QC Criteria: November 2, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2023-1779

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No