Clinical trial NCT04326816: Restorative Treatment of Severe Tooth Wear; Direct vs Indirect
Official title: Restorative Treatment of Severe Tooth Wear; Direct vs Indirect
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Wear
Dental Restoration Failure
Dental Restoration Wear
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Ivoclar Vivadent AG
First posted: 2020-03-30
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After written informed consent, patients fulfilling the inclusion criteria were assigned to an experimental group using block randomization with a block size of eight and the trial design had an intended allocation ratio of 1:1. Patients were allocated randomly to one of the two restorative treatment protocols: (1) Direct Composite restorations (DCR): using direct composite restorations on all teeth or (2) Indirect Composite Restorations (ICR): using ICR on all first molars and palatal veneer restorations on maxillary anterior teeth and DCR on remaining teeth.
Primary purpose: TREATMENT

Brief summary: This study compares the survival rates of both direct and indirect resin-based composite restorations in the treatment of severe tooth wear.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Failure level 1
timeFrame: Failures 3 years after placement
measure: Failure level 2
timeFrame: Failures 3 years after placement
measure: Failure level 3
timeFrame: Failures 3 years after placement
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Radboud University Medical Center
name: Bas Loomans, PhD, DDS
role: STUDY_DIRECTOR
References: