NCT Number: NCT04326816
Restorative Treatment of Severe Tooth Wear; Direct vs Indirect
This study compares the survival rates of both direct and indirect resin-based composite restorations in the treatment of severe tooth wear.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
About this study
Tooth wear can lead to pain, discomfort and unsatisfying dental attractiveness and when severe, it can compromise the dentition's prognosis. Restorative therapies for treatment of severe tooth wear should be preferably minimally invasive and adhesive.
This study compares two different treatment techniques for severe tooth wear. The first technique is regarded as the 'standard' technique. This is a full rehabilitation using only direct composite restorations (AP-X, Kuraray, Japan).
The second technique comprises a full rehabilitation using both direct and indirect resin composite restorations (Estenia C&B, Kuraray, Japan). 10 indirect restorations are placed on specific elements i.e. first molars and palatal sides of all maxillary anterior teeth. Other elements are restored conform the direct protocol.
An important benefit for the patients is the rehabilitation of their worn dentitions. Functionality (teeth are less sensitive, improved chewing ability, better occlusal stability, etc) and aesthetics will be improved immediately after finishing the treatment.
Indirect techniques have the advantage of a superior control over form of restorations.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients age of at least 18 years old.
- Generalized moderate to severe tooth wear (Tooth Wear Index (TWI) ≥ 2) with a patient demand for treatment (Smith 1984)
- Full dental arches, but one diastema due to one missing tooth in the posterior area was allowed.
- An estimated need for increase of vertical dimension of occlusion (VDO) of ≥3mm at the location of the first molars.
Exclusion criteria
- Limited mouth opening (<3.5cm).
- (History of) Temporomandibular dysfunction, periodontitis, deep caries lesions or multiple endodontic problems.
- Local or systemic conditions that would contra-indicate dental procedures.
Patients with specific individual risk factors, such as parafunctional habits of grinding/clenching or patients with GORD (Gastro Oesophageal Reflex Disease), were not excluded.
Treatment and study plan
Primary outcomes
-
Failure level 1
Time frame: Failures 3 years after placement
Number of replaced direct and indirect restorations in the treatment. The higher the number the worse the outcome.
-
Failure level 2
Time frame: Failures 3 years after placement
Number of repaired direct and indirect restorations in the treatment. The higher the number the worse the outcome.
-
Failure level 3
Time frame: Failures 3 years after placement
Number of refurbished direct and indirect restorations in the treatment due to material chippings. The higher the number the worse the outcome.
Sponsors and collaborators
Lead sponsor
Radboud University Medical Center
Other
Collaborators
- Ivoclar Vivadent AG
Registry information
Important dates
- Study start
- 2010
- Primary completion
- 2021
- Study completion
- 2021
- First posted
- Mar 30, 2020
- Registry last updated
- Mar 18, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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