Testing New Vertical Dimension Of Occlusion Prior To Restorative Treatment Of Tooth Wear

NCT04797494 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2021-03-15

No results posted yet for this study

Summary

This study is a Randomized Controlled Trial (RCT). The aim of the study is to evaluate the necessity to test the desired increased Vertical Dimension of Occlusion (VDO) prior to restorative treatment of generalized tooth wear.

Tooth wear is a physiological phenomenon, that when becoming pathological, can result in functional problems such as pain, reduced quality of life and esthetic impairment. Restorative treatment should be discussed with patients with severe or pathological tooth wear.

The restorative treatment of generalized tooth wear includes restoration of teeth, separately, in increased VDO. The increment of VDO is based upon clinical parameters such as the amount of natural tooth tissue, the possibility to lengthen the anterior teeth in regard to an acceptable esthetics outcome, and the Free Way Space (FWS). The FWS is the intermaxillary space when the masticatory-muscles-complex is relaxed.

Traditionally, it is believed that adapting to a new VDO results in clinical difficulties such as different speech, pain of the Temporo Mandibular Joint (TMJ), masticatory muscle pain, and increased masticatory muscles activity. The latter could result in an increased bite force and (possibly) an increased failure rate of restorations. Some operators, then, prefer to test the increment of VDO prior to restorative treatment to check if patients can adjust to the new VDO. This raises the question if the needed increment of VDO to restore worn dentitions should be checked prior to restorative treatment. The hypothesis in this study is that testing the needed increment of VDO prior to restorative treatment does not improve the restorative treatment.

Patients with generalized severe tooth wear were included and restoratively treated with composite restorations. Prior to restorative treatment, patients were randomized to either receiving an acrylic Removable Appliance (RA) or no RA. The RA was worn for 3 weeks prior to restorative treatment and included the intended increment of VDO. These patients were asked to wear the RA during the whole day, except when eating.

After restorative treatment, patients revisited our dental clinic after 1 month and after 1 year. Quality of life was assessed with questionnaires. FWS was assessed clinically. Restorations were checked for clinical acceptability, including small materials fractures.

Conditions

  • Tooth Wear
  • Randomized Controlled Trial
  • Vertical Dimension of Occlusion
  • Composite Resins

Interventions

DEVICE

acrylic removable appliance

Hand-made, dental laboratory-manufactured, acrylic removable appliances were made on the mandible after intraoral impressions (Alginate, Cavex). Patients were asked to wear the RA for a period of 3 weeks prior to restorative treatment, for 24 h per day, except for when eating.

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Marie-Charlotte Huysmans, Prof. Dr. · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2016-02-14
Completion
2016-02-14

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04797494 on ClinicalTrials.gov