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Restorative Treatment of Severe Tooth Wear; Direct vs Indirect

Restorative Treatment of Severe Tooth Wear; Direct vs Indirect

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04326816
Enrollment
42
Registered
2020-03-30
Start date
2010-11-30
Completion date
2021-03-31
Last updated
2021-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Restoration Failure, Dental Restoration Wear, Tooth Wear

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.

Interventions

PROCEDURERehabilitation of severely worn dentitions using minimally invasive composite restorations (Estenia C&B or Clearfil AP-X, Kuraray, Osaka, Japan)

Sponsors

Ivoclar Vivadent AG
CollaboratorINDUSTRY
Radboud University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Failure level 1Failures 3 years after placementNumber of replaced direct and indirect restorations in the treatment. The higher the number the worse the outcome.
Failure level 2Failures 3 years after placementNumber of repaired direct and indirect restorations in the treatment. The higher the number the worse the outcome.
Failure level 3Failures 3 years after placementNumber of refurbished direct and indirect restorations in the treatment due to material chippings. The higher the number the worse the outcome.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026