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

Tooth Wear Clinical Trial

— NTWP  

Official title:

The Use of LAVA Ultimate Restorations in a Full Occlusal Rehabilitation for Patients With Severe Tooth Wear

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02957734
• Other study ID #: NTWP-LAVA2016
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: January 2016
• Est. completion date: September 2022

Study information

• Verified date: September 2021
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: September 2022
• Est. primary completion date: September 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dental Restoration Failure
• Dental Restoration Wear
• Tooth Wear

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Radboud University Medical Center	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	3M ESPE

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. Epub 2016 Feb 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Failures one year after placement