NCT04790110

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2011

Completed
9.9 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2022

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

February 23, 2024

Status Verified

October 1, 2022

Enrollment Period

11.2 years

First QC Date

February 9, 2021

Last Update Submit

February 22, 2024

Conditions

Tooth WearReflux AcidBruxism

Keywords

Progression of tooth wear

Outcome Measures

Primary Outcomes (1)

  • degree of dental wear in height

    µm per year

    7 years

Secondary Outcomes (1)

  • The use of index teeth

    7 years

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Medical Center

Nijmegen, Gelderland, 6525EX, Netherlands

Location

Related Publications (3)

  • 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.

    PMID: 28267825BACKGROUND

  • 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.

    PMID: 28439579BACKGROUND

  • Bronkhorst 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.

    PMID: 37683799DERIVED

MeSH Terms

Conditions

Tooth WearGastroesophageal RefluxBruxism

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesHabitsBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2021

First Posted

March 10, 2021

Study Start

March 3, 2011

Primary Completion

May 21, 2022

Study Completion

June 1, 2022

Last Updated

February 23, 2024

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)