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Full Occlusal Rehabilitation for Patients With Severe Tooth Wear Using Indirect Composite Restorations (NTWP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02957734
Recruitment Status : Active, not recruiting
First Posted : November 8, 2016
Last Update Posted : April 1, 2019
Information provided by (Responsible Party):
Radboud University

Brief Summary:
LAVA Ultimate composite restorations will be used as restorative material to reconstruct severely worn dentitions.

Condition or disease Intervention/treatment Phase
Tooth Wear Dental Restoration Failure Dental Restoration Wear Procedure: Rehabilitation of severely worn dentitions Early Phase 1

Detailed Description:

Standard dental treatment will be provided to the patients with severely worn dentitions. Treatment is based on the principles of 'minimally invasive treatment techniques'.

Main difference with the 'standard' treatment protocol and the standard procedure of placing composite restorations is the fully digital workflow. In the traditional workflow a silicon impression is made, after which the dental technician produces the (indirect) composite restorations in by hand. These restorations are then adhesively cemented on the teeth by the dentist. In the fully digital workflow, digital 3D-scans are made using the 3D LAVA scanner (3M ESPE). Based on these digital 3D-images a digital wax-up is made by the dental technician after which all composite restorations (uplays and backings) are designed digitally before being milled and finally adhesively cemented on the teeth by the dentists. An important benefit for the patients is the rehabilitation of their worn dentitions. Functionality (teeth are less sensitive, improved chewing ability, a better occlusal stability, etc) and aesthetics will be improved immediately after finishing the treatment. Moreover, the estimated treatment time will be less (estimated treatment time approx. 12hours) than the traditional methods when using the standard treatment protocol (estimated treatment time approx. 18hours).

Another potential benefit is a better control and more predictable results by using 3D-images with the pre-designed computer simulation.

A risk of these indirect composite resin restorations is the unknown survival rate compared to other indirect as well as to direct application technique

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of LAVA Ultimate Restorations in a Full Occlusal Rehabilitation for Patients With Severe Tooth Wear
Actual Study Start Date : January 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: LAVA Ultimate restorations
For rehabilitation of the severely worn teeth, teeth are prepared (based on Minimal Invasive procedures), scanned using an intra-oral 3D-scanner (TrueDef, 3M), a digital wax-up model is made and finally restorations are milled from a pre polymerized block of resin (LAVA Ultimate). These indirect restorations are then adhesively cemented on the teeth (Relyx Ultimate, 3M). Teeth on which no indirect restoration could be made/designed a direct composite restoration was made using Filtek Supreme XTE in combination with Scotchbond Universal. Furthermore, all anterior veneer restorations are made of direct composite restorations (Filtek Supreme XTE in combination with Scotchbond Universal).
Procedure: Rehabilitation of severely worn dentitions
Patients with severely worn dentition and functional problems are included in this study. Teeth are rehabilitated using indirect composite resin restorations in an increased vertical dimension of occlusion in order to optimize function and esthetics.

Primary Outcome Measures :
  1. Surival of indirect composite restorations in patients treated for severe tooth wear [ Time Frame: Failures one year after placement ]
    Percentage of failed restorations and the clinical success of the restorations and the relation of the failures with etiological factors

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Generalized severe tooth wear
  • Presence of functional problems
  • Necessary increase of vertical dimension of occlusion (VDO) of ≥3 mm at location of first molars
  • No edentulous space in need for treatment in the anterior region in upper and lower jaw
  • A minimum of three posterior teeth (premolars and molars) per quadrant

Exclusion Criteria:

  • ASA 4
  • Functional problems (mouth opening < 5cm, severe Tempero Mandibular Dysfunction)
  • Severe periodontitis (DPSI = 4)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02957734

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Radboud University Medical Center
Nijmegen, Gelderland, Netherlands, 6525EX
Sponsors and Collaborators
Radboud University
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Responsible Party: Radboud University Identifier: NCT02957734    
Other Study ID Numbers: NTWP-LAVA2016
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Radboud University:
Vertical dimension of occlusion
Direct composite restorations
Indirect composite restorations
Tooth wear
Quality of Life
Additional relevant MeSH terms:
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Tooth Wear
Tooth Attrition
Tooth Diseases
Stomatognathic Diseases