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CompletedNCT04790110Updated Feb 23, 2024

7 Year Follow up Analysis on the Speed of Progression of Tooth Wear Using 3D Subtraction

An observational study in Tooth Wear, Reflux Acid and Bruxism, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-23.

Sponsored by Radboud University Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
55
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Tooth Wear
  • Reflux Acid
  • Bruxism

Keywords

  • Progression of tooth wear
03

In context

Tooth Wear

62 studies on the registry are indexed under Tooth Wear; 12 are open to participants now.

This study's enrollment of 55 is below the median of 71 across 21 observational studies indexed under Tooth Wear.

Browse Tooth Wear studies →

Lead sponsor

Radboud University Medical Center is the lead sponsor of 986 studies on the registry; 136 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
55 participants (actual)
Target follow-up
7 Years
Patient registry
Yes

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. degree of dental wear in height

    µm per year

    Time frame: 7 years

Secondary outcomes

  1. The use of index teeth

    ICC correlation between ranking of patients according to whole dentition or index teeth

    Time frame: 7 years

07

Study locations

1 site
  • Radboud University Medical Center
    Nijmegen, Gelderland 6525EX, Netherlands
08

References and documents

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 28267825 ↗
  • Loomans 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 28439579 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2011 to primary completion in May 2022, 134 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 9, 2021
First posted
Mar 10, 2021
StartActual
Mar 3, 2011
Primary completionActual
May 21, 2022
CompletionActual
Jun 1, 2022
Last update
Feb 23, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04790110
Collaborators
Stichting Bevordering Tandheelkundige Kennis of the Nederlands Tijdschrift voor Tandheelkunde
Responsible party
Sponsor
First posted
Mar 10, 2021
Start date
Mar 3, 2011
Primary completion
May 21, 2022
Completion
Jun 1, 2022
Last update
Feb 23, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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