Tooth Wear:m Tooth Wear : Diagnosis- Treatment Decision
Tooth Wear : Diagnosis- Treatment Decision- Management- Monitoring- Randomized Clinical Trial
1 other identifier
interventional
52
1 country
1
Brief Summary
Tooth wear is a physiological process occurring from normal functioning of the dentition throughout lifetime.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 26, 2018
CompletedFirst Submitted
Initial submission to the registry
March 5, 2018
CompletedFirst Posted
Study publicly available on registry
May 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedMarch 11, 2019
March 1, 2019
2.8 years
March 5, 2018
March 7, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Restoration
by modified USPHS criteria
up to 3 years
Study Arms (2)
Composite resin
ACTIVE COMPARATORRestoration with composite resin has shown good clinical performance and limited occlusal wear. The Clearfil Majesty will be used in the present study.
Polymer-infiltrated-ceramic-network
ACTIVE COMPARATORThis hybrid material seems to be a promising material that imitates natural tooth properties. The VITA-Enamic® will be used in this study.
Interventions
Tooth wear - polymer-infiltrated-ceramic-network
Eligibility Criteria
You may qualify if:
- Patients aged 18 years or older, in good general health, willing to participate in the study and accepting to come to regular controls in the future.
- Patients representing any type of significant tooth wear (≥ 1 mm depth) with dentine exposure in at least 4 teeth: localized tooth wear anterior or posterior teeth and generalized tooth wear anterio and posterior teeth.
- Patients having posterior support with at least 4 molars in occlusion, 1 pair per side, excluding third molar.
You may not qualify if:
- Patients wearing removable partial prosthesis
- Patients presenting skeletal Cl III occlusal Relationship
- Patients with remaining clinical crown of ≤ 3 mm in height and presenting tooth anomaly in shape and number in addition to anterior diastemas.
- Patients with symptomatic temporomandibular joint disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
De Carvalho Joana, Dentist, Pr
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The statistician will be blind to the treatment assigned to indivivual patients.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2018
First Posted
May 30, 2018
Study Start
February 26, 2018
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
March 11, 2019
Record last verified: 2019-03