Tooth WearPhase 4NTWPNCT02957734
Full Occlusal Rehabilitation for Patients With Severe Tooth Wear Using Indirect Composite Restorations
A Phase 4 study testing Rehabilitation of severely worn dentitions in people with Tooth Wear and Dental Restoration Failure, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
LAVA Ultimate composite restorations will be used as restorative material to reconstruct severely worn dentitions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Wear, Dental Restoration Failure, Dental Restoration Wear
- What is being tested?
- Rehabilitation of severely worn dentitions
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2016to Sep 2022
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Generalized severe tooth wear
- Presence of functional problems
- Necessary increase of vertical dimension of occlusion (VDO) of ≥3 mm at location of first molars
- No edentulous space in need for treatment in the anterior region in upper and lower jaw
- A minimum of three posterior teeth (premolars and molars) per quadrant
Who cannot join
- ASA 4
- Functional problems (mouth opening < 5cm, severe Tempero Mandibular Dysfunction)
- Severe periodontitis (DPSI = 4)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Medical Center
Nijmegen, Gelderland, 6525EX
About this study
Official title: The Use of LAVA Ultimate Restorations in a Full Occlusal Rehabilitation for Patients With Severe Tooth Wear
LAVA Ultimate composite restorations will be used as restorative material to reconstruct severely worn dentitions.
Read the detailed description
Standard dental treatment will be provided to the patients with severely worn dentitions. Treatment is based on the principles of 'minimally invasive treatment techniques'.
Main difference with the 'standard' treatment protocol and the standard procedure of placing composite restorations is the fully digital workflow. In the traditional workflow a silicon impression is made, after which the dental technician produces the (indirect) composite restorations in by hand. These restorations are then adhesively cemented on the teeth by the dentist. In the fully digital workflow, digital 3D-scans are made using the 3D LAVA scanner (3M ESPE). Based on these digital 3D-images a digital wax-up is made by the dental technician after which all composite restorations (uplays and backings) are designed digitally before being milled and finally adhesively cemented on the teeth by the dentists. An important benefit for the patients is the rehabilitation of their worn dentitions. Functionality (teeth are less sensitive, improved chewing ability, a better occlusal stability, etc) and aesthetics will be improved immediately after finishing the treatment. Moreover, the estimated treatment time will be less (estimated treatment time approx. 12hours) than the traditional methods when using the standard treatment protocol (estimated treatment time approx. 18hours).
Another potential benefit is a better control and more predictable results by using 3D-images with the pre-designed computer simulation.
A risk of these indirect composite resin restorations is the unknown survival rate compared to other indirect as well as to direct application technique
- Being tested
- Rehabilitation of severely worn dentitions
- Keywords
- Vertical dimension of occlusion, Direct composite restorations, Indirect composite restorations, Tooth wear, Failure, Quality of Life
- 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 dentitionsProcedure or surgery
Patients with severely worn dentition and functional problems are included in this study. Teeth are rehabilitated using indirect composite resin restorations in an increased vertical dimension of occlusion in order to optimize function and esthetics.
| Study group | Role | What they receive |
|---|---|---|
| LAVA Ultimate restorations | Experimental | For rehabilitation of the severely worn teeth, teeth are prepared (based on Minimal Invasive procedures), scanned using an intra-oral 3D-scanner (TrueDef, 3M), a digital wax-up model is made and finally restorations are milled from a pre polymerized block of resin (LAVA Ultimate). These indirect restorations are then adhesively cemented on the teeth (Relyx Ultimate, 3M). Teeth on which no indirect restoration could be made/designed a direct composite restoration was made using Filtek Supreme XTE in combination with Scotchbond Universal. Furthermore, all anterior veneer restorations are made of direct composite restorations (Filtek Supreme XTE in combination with Scotchbond Universal). Receives: Procedure: Rehabilitation of severely worn dentitions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surival of indirect composite restorations in patients treated for severe tooth wear
Percentage of failed restorations and the clinical success of the restorations and the relation of the failures with etiological factors
Measured: Failures one year after placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startJan 2016
- Primary completionSep 2019
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- 3M ESPE
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957734
- Sponsor's protocol ID
- NTWP-LAVA2016
- Acronym
- NTWP
- Status last verified
- Sep 2021
- First submitted
- 12 Oct 2016
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Opdam N, Skupien JA, Kreulen CM, Roeters J, Loomans B, Huysmans MD. Case Report: A Predictable Technique to Establish Occlusal Contact in Extensive Direct Composite Resin Restorations: The DSO-Technique. Oper Dent. 2016 Sep;41(S7):S96-S108. doi: 10.2341/13-112-T. Epub 2016 Feb 26.
PubMed 26918925Maier E, Crins L, Pereira-Cenci T, Bronkhorst E, Opdam N, Galler K, Loomans B. 5.5-year-survival of CAD/CAM resin-based composite restorations in severe tooth wear patients. Dent Mater. 2024 May;40(5):767-776. doi: 10.1016/j.dental.2024.03.001. Epub 2024 Mar 7.
PubMed 38458918
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of LAVA Ultimate Restorations in a Full Occlusal Rehabilitation for Patients With Severe Tooth Wear
- ClinicalTrials.gov ID
- NCT02957734
- Acronym / sponsor ID
- NTWP / NTWP-LAVA2016
- Keywords
- Vertical dimension of occlusion, Direct composite restorations, Indirect composite restorations, Tooth wear, Failure, Quality of Life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- 3M ESPE
- Study start
- Jan 2016 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2022 (estimated)
- First posted
- 8 Nov 2016 (estimated)
- 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.
LAVA Ultimate composite restorations will be used as restorative material to reconstruct severely worn dentitions.
Detailed description
Standard dental treatment will be provided to the patients with severely worn dentitions. Treatment is based on the principles of 'minimally invasive treatment techniques'.
Main difference with the 'standard' treatment protocol and the standard procedure of placing composite restorations is the fully digital workflow. In the traditional workflow a silicon impression is made, after which the dental technician produces the (indirect) composite restorations in by hand. These restorations are then adhesively cemented on the teeth by the dentist. In the fully digital workflow, digital 3D-scans are made using the 3D LAVA scanner (3M ESPE). Based on these digital 3D-images a digital wax-up is made by the dental technician after which all composite restorations (uplays and backings) are designed digitally before being milled and finally adhesively cemented on the teeth by the dentists. An important benefit for the patients is the rehabilitation of their worn dentitions. Functionality (teeth are less sensitive, improved chewing ability, a better occlusal stability, etc) and aesthetics will be improved immediately after finishing the treatment. Moreover, the estimated treatment time will be less (estimated treatment time approx. 12hours) than the traditional methods when using the standard treatment protocol (estimated treatment time approx. 18hours).
Another potential benefit is a better control and more predictable results by using 3D-images with the pre-designed computer simulation.
A risk of these indirect composite resin restorations is the unknown survival rate compared to other indirect as well as to direct application technique
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LAVA Ultimate restorations | Experimental | Procedure: Rehabilitation of severely worn dentitionsFor rehabilitation of the severely worn teeth, teeth are prepared (based on Minimal Invasive procedures), scanned using an intra-oral 3D-scanner (TrueDef, 3M), a digital wax-up model is made and finally restorations are milled from a pre polymerized block of resin (LAVA Ultimate). These indirect restorations are then adhesively cemented on the teeth (Relyx Ultimate, 3M). Teeth on which no indirect restoration could be made/designed a direct composite restoration was made using Filtek Supreme XTE in combination with Scotchbond Universal. Furthermore, all anterior veneer restorations are made of direct composite restorations (Filtek Supreme XTE in combination with Scotchbond Universal). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Generalized severe tooth wear
- Presence of functional problems
- Necessary increase of vertical dimension of occlusion (VDO) of ≥3 mm at location of first molars
- No edentulous space in need for treatment in the anterior region in upper and lower jaw
- A minimum of three posterior teeth (premolars and molars) per quadrant
Key exclusion criteria (3 listed)
- ASA 4
- Functional problems (mouth opening < 5cm, severe Tempero Mandibular Dysfunction)
- Severe periodontitis (DPSI = 4)
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 dentitionsPatients with severely worn dentition and functional problems are included in this study. Teeth are rehabilitated using indirect composite resin restorations in an increased vertical dimension of occlusion in order to optimize function and esthetics. | Procedure or surgery | LAVA Ultimate restorations |
Primary outcome
Surival of indirect composite restorations in patients treated for severe tooth wear
Time frame: Failures one year after placement
Percentage of failed restorations and the clinical success of the restorations and the relation of the failures with etiological factors
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Background: PubMed 26918925Opdam N, Skupien JA, Kreulen CM, Roeters J, Loomans B, Huysmans MD. Case Report: A Predictable Technique to Establish Occlusal Contact in Extensive Direct Composite Resin Restorations: The DSO-Technique. Oper Dent. 2016 Sep;41(S7):S96-S108. doi: 10.2341/13-112-T. Epub 2016 Feb 26.
- Derived from this study: PubMed 38458918Maier E, Crins L, Pereira-Cenci T, Bronkhorst E, Opdam N, Galler K, Loomans B. 5.5-year-survival of CAD/CAM resin-based composite restorations in severe tooth wear patients. Dent Mater. 2024 May;40(5):767-776. doi: 10.1016/j.dental.2024.03.001. Epub 2024 Mar 7.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rehabilitation of severely worn dentitions in people with Tooth Wear and Dental Restoration Failure, run by Radboud University Medical Center at 1 site in Netherlands.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Surival of indirect composite restorations in patients treated for severe tooth wear (time frame: Failures one year after placement). 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 NCT02957734, which also lists 2 linked publications.
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 23 Sep 2021.