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

Radboud University Medical Center

Status and phase: Unknown; Phase 4

Conditions: Tooth Wear; Dental Restoration Failure; Dental Restoration Wear

Treatments: Procedure: Rehabilitation of severely worn dentitions

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02957734

NTWP-LAVA2016

Details and patient eligibility

About

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

Full 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

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

LAVA Ultimate restorations

Experimental group

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).

Treatment:

Procedure: Rehabilitation of severely worn dentitions