NCT02957734

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2016

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

3.7 years

First QC Date

October 12, 2016

Last Update Submit

September 16, 2021

Conditions

Tooth WearDental Restoration FailureDental Restoration Wear

Keywords

Vertical dimension of occlusionDirect composite restorationsIndirect composite restorationsTooth wearFailureQuality of Life

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

LAVA Ultimate restorations

EXPERIMENTAL

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).

Procedure: Rehabilitation of severely worn dentitions

Interventions

Rehabilitation of severely worn dentitionsPROCEDURE

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.

LAVA Ultimate restorations

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • ASA 4
  • Functional problems (mouth opening \< 5cm, severe Tempero Mandibular Dysfunction)
  • Severe periodontitis (DPSI = 4)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Medical Center

Nijmegen, Gelderland, 6525EX, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 26918925BACKGROUND

  • 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.

    PMID: 38458918DERIVED

MeSH Terms

Conditions

Tooth Wear

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2016

First Posted

November 8, 2016

Study Start

January 1, 2016

Primary Completion

September 1, 2019

Study Completion

September 1, 2022

Last Updated

September 23, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)