Restorative Treatment of Severe Tooth Wear; Direct vs Indirect

NCT04326816 | Completed

• 1 other identifier: 2010/203
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study compares the survival rates of both direct and indirect resin-based composite restorations in the treatment of severe tooth wear.

Conditions

Tooth Wear; Dental Restoration Failure; Dental Restoration Wear

Outcome Measures

Primary Outcomes (3)

• Failure level 1

  Number of replaced direct and indirect restorations in the treatment. The higher the number the worse the outcome.

  Failures 3 years after placement

• Failure level 2

  Number of repaired direct and indirect restorations in the treatment. The higher the number the worse the outcome.

  Failures 3 years after placement

• 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.

  Failures 3 years after placement

Study Arms (2)

Direct Composite Restorations (DCR)

ACTIVE COMPARATOR

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.

Procedure: Rehabilitation of severely worn dentitions using minimally invasive composite restorations (Estenia C&B or Clearfil AP-X, Kuraray, Osaka, Japan)

Indirect Composite Restorations (ICR)

EXPERIMENTAL

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).

Procedure: Rehabilitation of severely worn dentitions using minimally invasive composite restorations (Estenia C&B or Clearfil AP-X, Kuraray, Osaka, Japan)

Interventions

Rehabilitation of severely worn dentitions using minimally invasive composite restorations (Estenia C&B or Clearfil AP-X, Kuraray, Osaka, Japan) PROCEDURE

Direct Composite Restorations (DCR); Indirect Composite Restorations (ICR)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Ivoclar Vivadent AG: collaborator

MeSH Terms

Conditions

Tooth Wear

Interventions

Clearfil AP-X

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Bas Loomans, PhD, DDS

  Radboud University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: March 30, 2020
• Study Start: November 1, 2010
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share