Wear, ToothGICNCT03624894
Intraoral Impressions for Assessment of Wear of Teeth and Restorative Materials.
An observational study of Wear, Tooth and Wear, Occlusal, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio.
Trial summary
Suitability of intraoral impressions for assessment of wear of teeth and restorative materials over 60 months, using the gypsum replica method and 3-D laser scanning: perspective clinical and laboratory evaluation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wear, Tooth, Wear, Occlusal, Wear, Restoration
- What is being tested?
- impression
- Type of treatment
- Pill or oral medicine
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2016to 16 Nov 2021
- Phase
- Observational
- 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
Study population: Subjects are recruit from patients that undergo a dental restorations independently from the present study
Who may be able to join
- Subject ≥18 years.
- Subjects with restorative treatments on vital teeth in posterior molar region. Will be considered at most one reconstruction per side.
- Restorations limited to two surfaces (Black's Class II) with one proximal cavity, in occlusion. Max 1 restoration will be included each oral side (right or left).
- Favorable and stable occlusal relationship between the remaining teeth.
- Subject must be reliable, cooperative, and in the opinion of the Investigator, likely to be compliant with study procedures.
- Subject provides written informed consent signed and dated prior to entering the study.
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- Subject ≥18 years.
- Subjects with restorative treatments on vital teeth in posterior molar region. Will be considered at most one reconstruction per side.
- Restorations limited to two surfaces (Black's Class II) with one proximal cavity, in occlusion. Max 1 restoration will be included each oral side (right or left).
- Favorable and stable occlusal relationship between the remaining teeth.
- Subject must be reliable, cooperative, and in the opinion of the Investigator, likely to be compliant with study procedures.
- Subject provides written informed consent signed and dated prior to entering the study.
Who cannot join
- Subject with full dentures or crowns and bridges in occlusal contact with teeth indicated for restorative treatment.
- Absence of occlusal contact.
- Subject has a history of drug abuse, addiction to medication or alcohol abuse within the previous year.
- Pulp exposure during restorative procedure or unvital teeth.
- Known unavailability of subject for recall Visit(s).
- Allergy to any ingredient of impression material.
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- Severe bruxism.
- Subject with clinically significant or unstable medical or physiological condition.
- Female subject is pregnant or lactating or intends to become pregnant during the course of the study.
- Subject is not willing to participate in the study or not able to understand the content of the study
About this study
Official title: Suitability of Intraoral Impressions for Assessment of Wear of Teeth and Restorative Materials Over 60 Months Using the Replica Method and 3-D Laser Equipment.
Suitability of intraoral impressions for assessment of wear of teeth and restorative materials over 60 months, using the gypsum replica method and 3-D laser scanning: perspective clinical and laboratory evaluation.
Read the detailed description
The study will assess suitability of intraoral impressions for assessment of wear of artificial dental restorative materials over 60 months. Subjects are recruit from patients that undergo a dental restorations independently from the present study. The sample size of n=65 would enable detection of differences in material and tooth wear greater than 10-13% from the baseline volume of teeth, when compared with volumes of teeth obtained from impressions taken at follow-ups, with the power of 0.8 and for the significance level of p=0.05. Paired t-test or a Wilcoxon signed-rank test is implemented depending on the distribution of the variables, for primary aim of evaluating suitability of polyvinylsiloxane dental impression for determination of wearing of teeth and restorative materials.
Paired t-test for each sub-score or a Wilcoxon-signed rank test is implemented, depending on the distribution of the variables, for secondary aims. Then, if variables are considered also as categorical, a Mc Nemar test for each sub-score will be suggested
- Conditions
- Wear, Tooth, Wear, Occlusal, Wear, Restoration
- Being tested
- impression
- Keywords
- oral impressions, glassionomer cements, dental restorations, dental wear
- Medical subject headings
- Tooth Wear, Tooth Attrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
impressionOther
common polyvinylsiloxane oral impression
| Study group | Role | What they receive |
|---|---|---|
| Patients that undergo a dental restorations | Patients that undergo a dental restorations independently from the present study Receives: Other: impression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wear of teeth and materials of restorations
3D models will be obtained from intraoral impressions taken at baseline, at 3 and at 5 years fo follow-up. 3D models obtained at different times will be compared by a 3D software (Aadva LabScan Software, GC Corporation, Japan), able to overlap the volumes and identify all areas where surfaces have been worn. The software is able to create graphical images of the occurred wear, but also to numerically quantify the volume lost due to wear. The software is able to evaluate differences till 0,001 mm, but for this study the limit for precision had been set to 0,01 mm.
Measured: 5 years
Secondary outcomes (1)
Level of wear of different restorative materials
The 3D evaluation of wear will identify the entity of wear for different substrates, and different behaviour of dental material will be possibly highlighted. Is it more than possible that under the same biting forces, different materials will show different wear, revealing which of them will be more suitable for long term, successful, dental restoration.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start1 Feb 2016
- Primary completion1 Feb 2021 (estimated)
- Study completion16 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wear, ToothStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624894
- Sponsor's protocol ID
- GIC
- Acronym
- GIC
- Status last verified
- Aug 2018
- First submitted
- 13 Mar 2018
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suitability of Intraoral Impressions for Assessment of Wear of Teeth and Restorative Materials Over 60 Months Using the Replica Method and 3-D Laser Equipment.
- ClinicalTrials.gov ID
- NCT03624894
- Acronym / sponsor ID
- GIC / GIC
- Conditions
- Wear, Tooth, Wear, Occlusal, Wear, Restoration
- Keywords
- oral impressions, glassionomer cements, dental restorations, dental wear
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 16 Nov 2021 (estimated)
- First posted
- 10 Aug 2018 (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.
Suitability of intraoral impressions for assessment of wear of teeth and restorative materials over 60 months, using the gypsum replica method and 3-D laser scanning: perspective clinical and laboratory evaluation.
Detailed description
The study will assess suitability of intraoral impressions for assessment of wear of artificial dental restorative materials over 60 months. Subjects are recruit from patients that undergo a dental restorations independently from the present study. The sample size of n=65 would enable detection of differences in material and tooth wear greater than 10-13% from the baseline volume of teeth, when compared with volumes of teeth obtained from impressions taken at follow-ups, with the power of 0.8 and for the significance level of p=0.05. Paired t-test or a Wilcoxon signed-rank test is implemented depending on the distribution of the variables, for primary aim of evaluating suitability of polyvinylsiloxane dental impression for determination of wearing of teeth and restorative materials.
Paired t-test for each sub-score or a Wilcoxon-signed rank test is implemented, depending on the distribution of the variables, for secondary aims. Then, if variables are considered also as categorical, a Mc Nemar test for each sub-score will be suggested
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients that undergo a dental restorations | – | Other: impressionPatients that undergo a dental restorations independently from the present study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects are recruit from patients that undergo a dental restorations independently from the present study
Key inclusion criteria (12 listed)
- Subject ≥18 years.
- Subjects with restorative treatments on vital teeth in posterior molar region. Will be considered at most one reconstruction per side.
- Restorations limited to two surfaces (Black's Class II) with one proximal cavity, in occlusion. Max 1 restoration will be included each oral side (right or left).
- Favorable and stable occlusal relationship between the remaining teeth.
- Subject must be reliable, cooperative, and in the opinion of the Investigator, likely to be compliant with study procedures.
Key exclusion criteria (10 listed)
- Subject with full dentures or crowns and bridges in occlusal contact with teeth indicated for restorative treatment.
- Absence of occlusal contact.
- Subject has a history of drug abuse, addiction to medication or alcohol abuse within the previous year.
- Pulp exposure during restorative procedure or unvital teeth.
- Known unavailability of subject for recall Visit(s).
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 |
|---|---|---|
| impressioncommon polyvinylsiloxane oral impression | Other | Patients that undergo a dental restorations |
Primary outcome
Wear of teeth and materials of restorations
Time frame: 5 years
3D models will be obtained from intraoral impressions taken at baseline, at 3 and at 5 years fo follow-up. 3D models obtained at different times will be compared by a 3D software (Aadva LabScan Software, GC Corporation, Japan), able to overlap the volumes and identify all areas where surfaces have been worn. The software is able to create graphical images of the occurred wear, but also to numerically quantify the volume lost due to wear. The software is able to evaluate differences till 0,001 mm, but for this study the limit for precision had been set to 0,01 mm.
1 secondary outcome
Level of wear of different restorative materials
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Wear, Tooth and Wear, Occlusal, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio.
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 12 inclusion and 10 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 10 Aug 2018. 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?
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?
Wear of teeth and materials of restorations (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2018.