An interventional study of Rehabilitation of severely worn dentitions using minimally invasive composite restorations (Estenia C&B or Clearfil AP-X, Kuraray, Osaka, Japan) in Tooth Wear, Dental Restoration Failure and Dental Restoration Wear, sponsored by Radboud University Medical Center. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-18.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Treatment
This study compares the survival rates of both direct and indirect resin-based composite restorations in the treatment of severe tooth wear.
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.
62 studies on the registry are indexed under Tooth Wear; 12 are open to participants now.
This study's enrollment of 42 is below the median of 49 across 41 interventional studies indexed under Tooth Wear.
Browse Tooth Wear studies →Radboud University Medical Center is the lead sponsor of 986 studies on the registry; 136 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Patients with specific individual risk factors, such as parafunctional habits of grinding/clenching or patients with GORD (Gastro Oesophageal Reflex Disease), were not excluded.
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 '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)
Failure level 1
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
Failure level 2
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
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.
Time frame: Failures 3 years after placement
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2010 to primary completion in Mar 2021, 124 months.
Of 21 interventional studies with no phase under Tooth Wear, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 30. This study's 124 months is above that.
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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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