Dental ImplantNCT06673563
A Clinical Study Collecting Patients' Experience During Dental Implant Treatment
An observational study of Dental Implant and Dental Restorations, run by Dr Robert Bowe.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implant, Dental Restorations, Patient Reported Outcome
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in need of a dental implant treatment
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Patient reported experience at Pre-Treatment, Baseline (Implant Insertion) and Up to 6 months (Final Prosthesis Delivery)
Measured: Pre-Treatment, Baseline (Implant Insertion), Up to 6 months (Final Prosthesis Delivery)
Secondary outcomes (7)
Patient reported experience at 1-Year Follow-up
Measured: 1-Year Follow-Up
OHIP-14 (summary score and separate questions)
Measured: Pre-Treatment, Baseline (Implant Insertion), Up to 6 months (Final Prosthesis Delivery), 1-Year Follow-Up
Patient satisfaction with esthetics and function (VAS)
Measured: Pre-Treatment, Baseline (Implant Insertion), Up to 6 months (Final Prosthesis Delivery), 1-Year Follow-Up
Implant survival
Measured: Up to 6 months (Final Prosthesis Delivery), 1-Year Follow-Up
Prosthetic survival
Measured: 1-Year Follow-Up Visit
Keratinized Mucosa Status
Measured: Up to 6 months (Final Prosthesis Delivery), 1-Year Follow-Up
Gingival Index
Measured: Up to 6 months (Final Prosthesis Delivery), 1-Year Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study startJan 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Robert Bowe
- Sponsor type
- University, hospital or other
- Collaborators
- Nobel Biocare
- Responsible party
- Sponsor-investigator, Dr Robert Bowe, Bowe Dental Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673563
- Sponsor's protocol ID
- 2023-1779
- Status last verified
- Nov 2024
- First submitted
- 31 Oct 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Patient-reported Experience Measure (PREM) in Implant Dentistry: an Exploratory Study
- ClinicalTrials.gov ID
- NCT06673563
- Acronym / sponsor ID
- 2023-1779
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Dr Robert BoweUniversity, hospital or other
- Collaborators
- Nobel Biocare
- Study start
- Jan 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in need of a dental implant treatment
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implant and Dental Restorations, run by Dr Robert Bowe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Bowe (+353 61 608 186, rob@bowedentalclinic.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.