A Clinical Study Collecting Patients' Experience During Dental Implant Treatment

NCT ID: NCT06673563

Last Updated: 2024-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

99 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-31

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dental Implant Dental Restorations Patient Reported Outcome Patient Experience

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Single tooth

Patient with the need of a single implant treatment

No interventions assigned to this group

Multiple teeth

Patients in need of two or more dental implants

No interventions assigned to this group

Full-arch

Patients in need of at least one All-on-4 treatment (with or without additional placed implants)

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nobel Biocare

INDUSTRY

Sponsor Role collaborator

Dr Robert Bowe

OTHER

Sponsor Role lead

Responsible Party

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Dr Robert Bowe

BA, BDentSc, MFD RCSI

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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Robert Bowe

Role: CONTACT

+353 61 608 186

Other Identifiers

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2023-1779

Identifier Type: -

Identifier Source: org_study_id

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