Tooth WearNCT04326816

Restorative Treatment of Severe Tooth Wear; Direct vs Indirect

A study testing Rehabilitation of severely worn dentitions using minimally invasive composite restorations (Estenia C&B or Clearfil AP-X, Kuraray, Osaka, Japan) in people with Tooth Wear and Dental Restoration Failure, run by Radboud University Medical Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Tooth Wear, Dental Restoration Failure, Dental Restoration Wear
What is being tested?: Rehabilitation of severely worn dentitions using minimally invasive composite restorations (Estenia C&B or Clearfil AP-X, Kuraray, Osaka, Japan)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: No sites listed yet
Study dates: Nov 2010to Mar 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

About this study

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

Read the 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.

Conditions: Tooth Wear, Dental Restoration Failure, Dental Restoration Wear
Being tested: Rehabilitation of severely worn dentitions using minimally invasive composite restorations (Estenia C&B or Clearfil AP-X, Kuraray, Osaka, Japan)
Medical subject headings: Tooth Wear

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04326816
Study group	Role	What they receive
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. Receives: 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). Receives: Procedure: Rehabilitation of severely worn dentitions using minimally invasive composite restorations (Estenia C&B or Clearfil AP-X, Kuraray, Osaka, Japan)

What is being measured

The primary outcome is the main question the study is designed to answer.

Failure level 1
Number of replaced direct and indirect restorations in the treatment. The higher the number the worse the outcome.
Measured: 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.
Measured: 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.
Measured: Failures 3 years after placement

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010Mar 2021

First posted30 Mar 2020
Study startNov 2010
Primary completionMar 2021
Study completionMar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Tooth WearStudies of the same condition, open and under way.
More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04326816
Sponsor's protocol ID: 2010/203
Status last verified: Mar 2021
First submitted: 18 Mar 2020
Last updated: 18 Mar 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingPhase 3
New In Situ Model Design for Caries and Erosion
Caries, Erosive Tooth Wear
Not yet recruiting
Applying Navigation and Care to Help Ongoing Retention
Child Obesity
Not yet recruitingObservational study
Salivary Function and Dental Changes During GLP-1 Therapy
Obesity, Dental Erosion
Not yet recruiting
Evaluation of Wear Resistance of CAD/CAM Hybrid Ceramic and Nano-Hybrid Composite Overlays in Endodontically Treated Molars and Their Effect on Natural Antagonist Teeth
Wear, Occlusal
Not yet recruiting
PRINTOW: Occlusal Wear of Denture Teeth in Digitally Fabricated Complete Dentures
Edentulism Complete, Edentulism

All Tooth Wear trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Restorative Treatment of Severe Tooth Wear; Direct vs Indirect
ClinicalTrials.gov ID: NCT04326816
Acronym / sponsor ID: 2010/203
Conditions: Tooth Wear, Dental Restoration Failure, Dental Restoration Wear
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Radboud University Medical CenterUniversity, hospital or other
Collaborators: Ivoclar Vivadent AG
Study start: Nov 2010 (actual)
Primary completion: Mar 2021 (actual)
Study completion: Mar 2021 (actual)
First posted: 30 Mar 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Indirect techniques have the advantage of a superior control over form of restorations.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Direct Composite Restorations (DCR)	Active comparator	Procedure: Rehabilitation of severely worn dentitions using minimally invasive composite restorations (Estenia C&B or Clearfil AP-X, Kuraray, Osaka, Japan)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 Composite Restorations (ICR)	Experimental	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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Rehabilitation of severely worn dentitions using minimally invasive composite restorations (Estenia C&B or Clearfil AP-X, Kuraray, Osaka, Japan)	Procedure or surgery	Direct Composite Restorations (DCR), Indirect Composite Restorations (ICR)

Primary outcome

Failure level 1
Time frame: Failures 3 years after placement
Number of replaced direct and indirect restorations in the treatment. The higher the number the worse the outcome.
Failure level 2
Time frame: Failures 3 years after placement
Number of repaired direct and indirect restorations in the treatment. The higher the number the worse the outcome.
Failure level 3
Time frame: Failures 3 years after placement
Number of refurbished direct and indirect restorations in the treatment due to material chippings. The higher the number the worse the outcome.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
Individual participant dataSharing planned: No

Related trials for Tooth Wear

Active, not recruitingPhase 3
New In Situ Model Design for Caries and Erosion
Caries, Erosive Tooth Wear
Not yet recruiting
Applying Navigation and Care to Help Ongoing Retention
Child Obesity
Not yet recruitingObservational study
Salivary Function and Dental Changes During GLP-1 Therapy
Obesity, Dental Erosion
Not yet recruiting
Evaluation of Wear Resistance of CAD/CAM Hybrid Ceramic and Nano-Hybrid Composite Overlays in Endodontically Treated Molars and Their Effect on Natural Antagonist Teeth
Wear, Occlusal
Not yet recruiting
PRINTOW: Occlusal Wear of Denture Teeth in Digitally Fabricated Complete Dentures
Edentulism Complete, Edentulism

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bas Loomans, PhD, DDS study director

Radboud University Medical Center

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Failure level 1 (time frame: Failures 3 years after placement). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04326816.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.