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Completed

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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Key information

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

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

Procedure

Primary outcomes

  1. 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.

  2. 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.

  3. 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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