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

Primary Purpose

Tooth Wear, Dental Restoration Failure, Dental Restoration Wear

Status
Unknown status
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Rehabilitation of severely worn dentitions
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Wear focused on measuring Vertical dimension of occlusion, Direct composite restorations, Indirect composite restorations, Tooth wear, Failure, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Radboud University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LAVA Ultimate restorations

Arm Description

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).

Outcomes

Primary Outcome Measures

Surival of indirect composite restorations in patients treated for severe tooth wear
Percentage of failed restorations and the clinical success of the restorations and the relation of the failures with etiological factors

Secondary Outcome Measures

Full Information

First Posted
October 12, 2016
Last Updated
September 16, 2021
Sponsor
Radboud University Medical Center
Collaborators
3M ESPE
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1. Study Identification

Unique Protocol Identification Number
NCT02957734
Brief Title
Full Occlusal Rehabilitation for Patients With Severe Tooth Wear Using Indirect Composite Restorations
Acronym
NTWP
Official Title
The Use of LAVA Ultimate Restorations in a Full Occlusal Rehabilitation for Patients With Severe Tooth Wear
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (Actual)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
3M ESPE

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Wear, Dental Restoration Failure, Dental Restoration Wear
Keywords
Vertical dimension of occlusion, Direct composite restorations, Indirect composite restorations, Tooth wear, Failure, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LAVA Ultimate restorations
Arm Type
Experimental
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Rehabilitation of severely worn dentitions
Intervention Description
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 Measure Information:
Title
Surival of indirect composite restorations in patients treated for severe tooth wear
Description
Percentage of failed restorations and the clinical success of the restorations and the relation of the failures with etiological factors
Time Frame
Failures one year after placement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Radboud University Medical Center
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525EX
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26918925
Citation
Opdam N, Skupien JA, Kreulen CM, Roeters J, Loomans B, Huysmans MD. Case Report: A Predictable Technique to Establish Occlusal Contact in Extensive Direct Composite Resin Restorations: The DSO-Technique. Oper Dent. 2016 Sep;41(S7):S96-S108. doi: 10.2341/13-112-T. Epub 2016 Feb 26.
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Full Occlusal Rehabilitation for Patients With Severe Tooth Wear Using Indirect Composite Restorations

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