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Restorative Treatment of Severe Tooth Wear; Direct vs Indirect

Primary Purpose

Tooth Wear, Dental Restoration Failure, Dental Restoration Wear

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rehabilitation of severely worn dentitions using minimally invasive composite restorations (Estenia C&B or Clearfil AP-X, Kuraray, Osaka, Japan)
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Wear

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients age of at least 18 years old.
  • Generalized moderate to severe tooth wear (Tooth Wear Index (TWI) ≥ 2) with a patient demand for treatment (Smith 1984)
  • Full dental arches, but one diastema due to one missing tooth in the posterior area was allowed.
  • An estimated need for increase of vertical dimension of occlusion (VDO) of ≥3mm at the location of the first molars.

Exclusion Criteria:

  • Limited mouth opening (<3.5cm).
  • (History of) Temporomandibular dysfunction, periodontitis, deep caries lesions or multiple endodontic problems.
  • Local or systemic conditions that would contra-indicate dental procedures.

Patients with specific individual risk factors, such as parafunctional habits of grinding/clenching or patients with GORD (Gastro Oesophageal Reflex Disease), were not excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Direct Composite Restorations (DCR)

    Indirect Composite Restorations (ICR)

    Arm Description

    All teeth were reconstructed with directly applied composite restorations. No preparation of teeth was performed except in cases of sharp occlusal edges. Rubberdam or cotton rolls and suction devices were used for moisture control. For bonding, a 3-step etch-and-rinse adhesive was applied according to manufacturer's instructions, using 37% phosphoric acid (DMG, Hamburg, Germany), Clearfil SA Primer, and Clearfil Photobond (Kuraray, Osaka, Japan). A micro-hybrid composite (Clearfil AP-X, Kuraray) was used for posterior restorations and palatal veneer restorations. Restorations were placed according to the DSO-technique (Direct Shaping by Occlusion). In front teeth, both a palatal and buccal veneer restoration was placed. Experimental restorations were all restorations on first molars and all palatal veneer restorations on maxillary anterior teeth.

    Indirect 'tabletop' restorations were placed on all first molars (n=4) and palatal veneers ('backings') (n=6) on maxillary anterior teeth. Remaining teeth received directly applied restorations. Preparation of teeth for indirect restorations was limited to removal of sharp edges. All indirect restorations were laboratory manufactured using a micro-hybrid composite (Clearfil Estenia C&B, Kuraray, Osaka, Japan). Adhesive surfaces of the restorations were air-abraded with aluminum-oxide powder (<50 µm). Rubberdam or cotton rolls were used for moisture control during cementation. Seating of indirect restorations was checked intraorally, followed by cleaning of its adhesive surface with phosphoric acid 37% and application of silane (Clearfil Ceramic Primer, Kuraray, Osaka Japan).The adhesive surface of the abutment tooth was etched with phosphoric acid and ED-primer II (Kuraray) was applied. Finally, restorations were cemented, using Panavia F (Kuraray).

    Outcomes

    Primary Outcome Measures

    Failure level 1
    Number of replaced direct and indirect restorations in the treatment. The higher the number the worse the outcome.
    Failure level 2
    Number of repaired direct and indirect restorations in the treatment. The higher the number the worse the outcome.
    Failure level 3
    Number of refurbished direct and indirect restorations in the treatment due to material chippings. The higher the number the worse the outcome.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 18, 2020
    Last Updated
    March 16, 2021
    Sponsor
    Radboud University Medical Center
    Collaborators
    Ivoclar Vivadent AG
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04326816
    Brief Title
    Restorative Treatment of Severe Tooth Wear; Direct vs Indirect
    Official Title
    Restorative Treatment of Severe Tooth Wear; Direct vs Indirect
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2010 (Actual)
    Primary Completion Date
    March 2021 (Actual)
    Study Completion Date
    March 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Radboud University Medical Center
    Collaborators
    Ivoclar Vivadent AG

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study compares the survival rates of both direct and indirect resin-based composite restorations in the treatment of severe tooth wear.
    Detailed Description
    Tooth wear can lead to pain, discomfort and unsatisfying dental attractiveness and when severe, it can compromise the dentition's prognosis. Restorative therapies for treatment of severe tooth wear should be preferably minimally invasive and adhesive. This study compares two different treatment techniques for severe tooth wear. The first technique is regarded as the 'standard' technique. This is a full rehabilitation using only direct composite restorations (AP-X, Kuraray, Japan). The second technique comprises a full rehabilitation using both direct and indirect resin composite restorations (Estenia C&B, Kuraray, Japan). 10 indirect restorations are placed on specific elements i.e. first molars and palatal sides of all maxillary anterior teeth. Other elements are restored conform the direct protocol. An important benefit for the patients is the rehabilitation of their worn dentitions. Functionality (teeth are less sensitive, improved chewing ability, better occlusal stability, etc) and aesthetics will be improved immediately after finishing the treatment. Indirect techniques have the advantage of a superior control over form of restorations.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tooth Wear, Dental Restoration Failure, Dental Restoration Wear

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    After written informed consent, patients fulfilling the inclusion criteria were assigned to an experimental group using block randomization with a block size of eight and the trial design had an intended allocation ratio of 1:1. Patients were allocated randomly to one of the two restorative treatment protocols: (1) Direct Composite restorations (DCR): using direct composite restorations on all teeth or (2) Indirect Composite Restorations (ICR): using ICR on all first molars and palatal veneer restorations on maxillary anterior teeth and DCR on remaining teeth.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    42 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Direct Composite Restorations (DCR)
    Arm Type
    Active Comparator
    Arm Description
    All teeth were reconstructed with directly applied composite restorations. No preparation of teeth was performed except in cases of sharp occlusal edges. Rubberdam or cotton rolls and suction devices were used for moisture control. For bonding, a 3-step etch-and-rinse adhesive was applied according to manufacturer's instructions, using 37% phosphoric acid (DMG, Hamburg, Germany), Clearfil SA Primer, and Clearfil Photobond (Kuraray, Osaka, Japan). A micro-hybrid composite (Clearfil AP-X, Kuraray) was used for posterior restorations and palatal veneer restorations. Restorations were placed according to the DSO-technique (Direct Shaping by Occlusion). In front teeth, both a palatal and buccal veneer restoration was placed. Experimental restorations were all restorations on first molars and all palatal veneer restorations on maxillary anterior teeth.
    Arm Title
    Indirect Composite Restorations (ICR)
    Arm Type
    Experimental
    Arm Description
    Indirect 'tabletop' restorations were placed on all first molars (n=4) and palatal veneers ('backings') (n=6) on maxillary anterior teeth. Remaining teeth received directly applied restorations. Preparation of teeth for indirect restorations was limited to removal of sharp edges. All indirect restorations were laboratory manufactured using a micro-hybrid composite (Clearfil Estenia C&B, Kuraray, Osaka, Japan). Adhesive surfaces of the restorations were air-abraded with aluminum-oxide powder (<50 µm). Rubberdam or cotton rolls were used for moisture control during cementation. Seating of indirect restorations was checked intraorally, followed by cleaning of its adhesive surface with phosphoric acid 37% and application of silane (Clearfil Ceramic Primer, Kuraray, Osaka Japan).The adhesive surface of the abutment tooth was etched with phosphoric acid and ED-primer II (Kuraray) was applied. Finally, restorations were cemented, using Panavia F (Kuraray).
    Intervention Type
    Procedure
    Intervention Name(s)
    Rehabilitation of severely worn dentitions using minimally invasive composite restorations (Estenia C&B or Clearfil AP-X, Kuraray, Osaka, Japan)
    Primary Outcome Measure Information:
    Title
    Failure level 1
    Description
    Number of replaced direct and indirect restorations in the treatment. The higher the number the worse the outcome.
    Time Frame
    Failures 3 years after placement
    Title
    Failure level 2
    Description
    Number of repaired direct and indirect restorations in the treatment. The higher the number the worse the outcome.
    Time Frame
    Failures 3 years after placement
    Title
    Failure level 3
    Description
    Number of refurbished direct and indirect restorations in the treatment due to material chippings. The higher the number the worse the outcome.
    Time Frame
    Failures 3 years after placement

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients age of at least 18 years old. Generalized moderate to severe tooth wear (Tooth Wear Index (TWI) ≥ 2) with a patient demand for treatment (Smith 1984) Full dental arches, but one diastema due to one missing tooth in the posterior area was allowed. An estimated need for increase of vertical dimension of occlusion (VDO) of ≥3mm at the location of the first molars. Exclusion Criteria: Limited mouth opening (<3.5cm). (History of) Temporomandibular dysfunction, periodontitis, deep caries lesions or multiple endodontic problems. Local or systemic conditions that would contra-indicate dental procedures. Patients with specific individual risk factors, such as parafunctional habits of grinding/clenching or patients with GORD (Gastro Oesophageal Reflex Disease), were not excluded.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bas Loomans, PhD, DDS
    Organizational Affiliation
    Radboud University Medical Center
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Restorative Treatment of Severe Tooth Wear; Direct vs Indirect

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