A Clinical Study Collecting Patients' Experience During Dental Implant Treatment

NCT06673563 | Not Yet Recruiting

• 1 other identifier: 2023-1779
• Study Type: observational
• Target: 99
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Implant; Dental Restorations; Patient Reported Outcome; Patient Experience

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (3)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in need of a dental implant treatment

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Robert Bowe: lead
• Nobel Biocare: collaborator

Central Study Contacts

Robert Bowe

CONTACT

+353 61 608 186; rob@bowedentalclinic.ie

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: BA, BDentSc, MFD RCSI

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 5, 2024
• Study Start: January 1, 2025
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share