Full Occlusal Rehabilitation for Patients With Severe Tooth Wear Using Indirect Composite Restorations
NCT ID: NCT02957734
Last Updated: 2021-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
22 participants
INTERVENTIONAL
2016-01-31
2022-09-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Functional problems (mouth opening \< 5cm, severe Tempero Mandibular Dysfunction)
* Severe periodontitis (DPSI = 4)
18 Years
ALL
Yes
Sponsors
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3M ESPE
INDUSTRY
Radboud University Medical Center
OTHER
Responsible Party
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Locations
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Radboud University Medical Center
Nijmegen, Gelderland, Netherlands
Countries
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References
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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.
Maier E, Crins L, Pereira-Cenci T, Bronkhorst E, Opdam N, Galler K, Loomans B. 5.5-year-survival of CAD/CAM resin-based composite restorations in severe tooth wear patients. Dent Mater. 2024 May;40(5):767-776. doi: 10.1016/j.dental.2024.03.001. Epub 2024 Mar 7.
Other Identifiers
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NTWP-LAVA2016
Identifier Type: -
Identifier Source: org_study_id
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