Tooth WearNCT04790110
7 Year Follow up Analysis on the Speed of Progression of Tooth Wear Using 3D Subtraction
An observational study of Tooth Wear and Reflux Acid, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Prospective observational study with 7-year follow up. 55 patients are included with moderate to severe tooth wear, whereby through informed consent the decision was taking to monitor the patients. At the baseline and 1, 3 5, and the 7-year recall digital 3D scans will be made, which will be compared and subtracted. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Wear, Reflux Acid, Bruxism
- Type of treatment
- Pill or oral medicine
- How many people
- 55 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Mar 2011to 1 Jun 2022
- How long will I take part?
- 7 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The participants in this research will be drawn from the RTWP (Radboud Tooth Wear Project) patient sample which consists of nearly 200 tooth wear patients. Patients are included through dentist referral or of their own volition. Out of this population, 55 patients are managed non-restoratively, because they do not experience problems in regards to their tooth wear, and have no restorative treatment need in their perception
Who may be able to join
- Generalized tooth wear
- A minimum of three posterior teeth (premolars and molars) per quadrant
- A maximum of one edentulous space in need for treatment, with a maximum span of one tooth-width
Who cannot join
- ASA 4
- Edentulous space has a span exceeding 1 tooth-width, or more than one space
- Functional problems (mouth opening <5cm, Temporomandibular Dysfunction)
- Severe periodontitis
- Strong gag reflex
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Medical Center
Nijmegen, Gelderland, 6525EX
About this study
Official title: The Progression of Tooth Wear and Possible Risk Factors: a 7 Year Follow up
Prospective observational study with 7-year follow up. 55 patients are included with moderate to severe tooth wear, whereby through informed consent the decision was taking to monitor the patients. At the baseline and 1, 3 5, and the 7-year recall digital 3D scans will be made, which will be compared and subtracted.
Read the detailed description
Prospective observational study with 7-year follow up. 55 patients are included with moderate to severe tooth wear, whereby through informed consent the decision was taking to monitor the patients. At the baseline and the 5-year recall digital 3D scans will be made, which will be compared and subtracted. Per tooth the loss of material is measured in maximum loss in height (µm) and volume (mm3) per year, using best fit alignment and 3D subtraction.
The loss of tooth material will be analyzed using descriptive statistics and possible effects of jaw type, tooth type and cusp type will be analyzed using multi level regression models.
The use of index teeth will be analyzed.
- Conditions
- Tooth Wear, Reflux Acid, Bruxism
- Keywords
- Progression of tooth wear
- Medical subject headings
- Tooth Wear, Gastroesophageal Reflux, Bruxism
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 |
|---|---|---|
| Studie A ESO - monitoring | Patients that present themselves at the clinic through referral from their dentist with tooth wear, who have no request for help, receive a non-restorative 'counseling \& monitoring' strategy , in which appropriate preventive measures are recommended and wear and tear is monitored and recorded by periodically taking intra-oral photographs and 3D scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
degree of dental wear in height
µm per year
Measured: 7 years
Secondary outcomes (1)
The use of index teeth
ICC correlation between ranking of patients according to whole dentition or index teeth
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start3 Mar 2011
- Primary completion21 May 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tooth WearStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- 55 participants (actual)
- Target duration
- 7 Years
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Stichting Bevordering Tandheelkundige Kennis of the Nederlands Tijdschrift voor Tandheelkunde
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04790110
- Sponsor's protocol ID
- NTWP-ESOA2020
- Status last verified
- Oct 2022
- First submitted
- 9 Feb 2021
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahmed KE, Whitters J, Ju X, Pierce SG, MacLeod CN, Murray CA. Clinical Monitoring of Tooth Wear Progression in Patients over a Period of One Year Using CAD/CAM. Int J Prosthodont. 2017 Mar/Apr;30(2):153-155. doi: 10.11607/ijp.4990.
PubMed 28267825Loomans B, Opdam N, Attin T, Bartlett D, Edelhoff D, Frankenberger R, Benic G, Ramseyer S, Wetselaar P, Sterenborg B, Hickel R, Pallesen U, Mehta S, Banerji S, Lussi A, Wilson N. Severe Tooth Wear: European Consensus Statement on Management Guidelines. J Adhes Dent. 2017;19(2):111-119. doi: 10.3290/j.jad.a38102.
PubMed 28439579Bronkhorst H, Bronkhorst E, Kalaykova S, Pereira-Cenci T, Huysmans MC, Loomans B. Inter- and intra-variability in tooth wear progression at surface-, tooth- and patient-level over a period of three years: A cohort study: Inter- and intra-variation in tooth wear progression. J Dent. 2023 Nov;138:104693. doi: 10.1016/j.jdent.2023.104693. Epub 2023 Sep 6.
PubMed 37683799
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Progression of Tooth Wear and Possible Risk Factors: a 7 Year Follow up
- ClinicalTrials.gov ID
- NCT04790110
- Acronym / sponsor ID
- NTWP-ESOA2020
- Conditions
- Tooth Wear, Reflux Acid, Bruxism
- Keywords
- Progression of tooth wear
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Stichting Bevordering Tandheelkundige Kennis of the Nederlands Tijdschrift voor Tandheelkunde
- Study start
- 3 Mar 2011 (actual)
- Primary completion
- 21 May 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 10 Mar 2021 (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.
Prospective observational study with 7-year follow up. 55 patients are included with moderate to severe tooth wear, whereby through informed consent the decision was taking to monitor the patients. At the baseline and 1, 3 5, and the 7-year recall digital 3D scans will be made, which will be compared and subtracted.
Detailed description
Prospective observational study with 7-year follow up. 55 patients are included with moderate to severe tooth wear, whereby through informed consent the decision was taking to monitor the patients. At the baseline and the 5-year recall digital 3D scans will be made, which will be compared and subtracted. Per tooth the loss of material is measured in maximum loss in height (µm) and volume (mm3) per year, using best fit alignment and 3D subtraction.
The loss of tooth material will be analyzed using descriptive statistics and possible effects of jaw type, tooth type and cusp type will be analyzed using multi level regression models.
The use of index teeth will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Studie A ESO - monitoring | – | –Patients that present themselves at the clinic through referral from their dentist with tooth wear, who have no request for help, receive a non-restorative 'counseling \& monitoring' strategy , in which appropriate preventive measures are recommended and wear and tear is monitored and recorded by periodically taking intra-oral photographs and 3D scans |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The participants in this research will be drawn from the RTWP (Radboud Tooth Wear Project) patient sample which consists of nearly 200 tooth wear patients. Patients are included through dentist referral or of their own volition. Out of this population, 55 patients are managed non-restoratively, because they do not experience problems in regards to their tooth wear, and have no restorative treatment need in their perception
Key inclusion criteria (3 listed)
- Generalized tooth wear
- A minimum of three posterior teeth (premolars and molars) per quadrant
- A maximum of one edentulous space in need for treatment, with a maximum span of one tooth-width
Key exclusion criteria (5 listed)
- ASA 4
- Edentulous space has a span exceeding 1 tooth-width, or more than one space
- Functional problems (mouth opening <5cm, Temporomandibular Dysfunction)
- Severe periodontitis
- Strong gag reflex
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
degree of dental wear in height
Time frame: 7 years
µm per year
1 secondary outcome
The use of index teeth
Time frame: 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Background: PubMed 28267825Ahmed KE, Whitters J, Ju X, Pierce SG, MacLeod CN, Murray CA. Clinical Monitoring of Tooth Wear Progression in Patients over a Period of One Year Using CAD/CAM. Int J Prosthodont. 2017 Mar/Apr;30(2):153-155. doi: 10.11607/ijp.4990.
- Background: PubMed 28439579Loomans B, Opdam N, Attin T, Bartlett D, Edelhoff D, Frankenberger R, Benic G, Ramseyer S, Wetselaar P, Sterenborg B, Hickel R, Pallesen U, Mehta S, Banerji S, Lussi A, Wilson N. Severe Tooth Wear: European Consensus Statement on Management Guidelines. J Adhes Dent. 2017;19(2):111-119. doi: 10.3290/j.jad.a38102.
- Derived from this study: PubMed 37683799Bronkhorst H, Bronkhorst E, Kalaykova S, Pereira-Cenci T, Huysmans MC, Loomans B. Inter- and intra-variability in tooth wear progression at surface-, tooth- and patient-level over a period of three years: A cohort study: Inter- and intra-variation in tooth wear progression. J Dent. 2023 Nov;138:104693. doi: 10.1016/j.jdent.2023.104693. Epub 2023 Sep 6.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth Wear and Reflux Acid, run by Radboud University Medical Center at 1 site in Netherlands.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
degree of dental wear in height (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04790110, which also lists 3 linked publications.
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 23 Feb 2024.