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

NCT04797494 | Completed Phase 2

• 1 other identifier: NL31371.091.10
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Randomized controlled trial; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Interventions on restorations

  Number of interventions needed for patients to adjust to the increased VDO

  Baseline, recall after 1 month, recall after 1 year.

Secondary Outcomes (3)

• Oral Health Impact Profile (OHIP) questionnaire

  Baseline, Recall after 1 month, recall after 1 year.

• Orofacial Esthetic Scale (OES) questionnaire

  Baseline, Recall after 1 month, recall after 1 year.

• Free Way Space

  Baseline, Recall after 1 month, recall after 1 year.

Study Arms (2)

Control Group

NO INTERVENTION

No acrylic Removable Appliance (RA) was prescribed for patients prior to restorative treatment of generalized severe tooth wear.

Experimental Group

EXPERIMENTAL

A acrylic Removable Appliance (RA) was prescribed for patients prior to restorative treatment of generalized severe tooth wear. Patients were asked to wear the RA 3 weeks prior to restorative treatment for 24h per day, except for when eating.

Device: acrylic removable appliance

Interventions

acrylic removable appliance DEVICE

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Generalized moderate to severe tooth wear with patient demand for treatment
• Full dental arches, one diastema due to one missing posterior tooth was allowed
• Estimated need for an increase in VDO of at least 3 mm in the first molar region

You may not qualify if:

• Limited mouth opening
• (History of) Temporomandibular dysfunction
• Advanced periodontitis, deep caries lesions, or multiple large restorations including teeth with endodontic problems
• Patients with specific individual risk factors, such as parafunctional habits of grinding/clenching or patients with Gastro-Oesophageal Reflux Disease (GORD), were not excluded.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud University Medical Center

Nijmegen, Gelderland, 6525EX, Netherlands

Location

MeSH Terms

Conditions

Tooth Wear

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Marie-Charlotte Huysmans, Prof. Dr.

  Radboud University Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a Randomized Controlled Trial (RCT)

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 15, 2021
• Study Start: January 1, 2010
• Primary Completion: February 14, 2016
• Study Completion: February 14, 2016
• Last Updated: March 15, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)