Clinical trial NCT02957734: Full Occlusal Rehabilitation for Patients With Severe Tooth Wear Using Indirect Composite Restorations
Official title: The Use of LAVA Ultimate Restorations in a Full Occlusal Rehabilitation for Patients With Severe Tooth Wear
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: 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
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: 3M ESPE
First posted: 2016-11-08
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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)

Primary outcomes:
measure: Surival of indirect composite restorations in patients treated for severe tooth wear
timeFrame: Failures one year after placement
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
state: Gelderland
Study officials:
References:
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.