Status unknownNCT03624894GICUpdated Aug 10, 2018

Intraoral Impressions for Assessment of Wear of Teeth and Restorative Materials.

An observational study in Wear, Tooth, Wear, Occlusal and Wear, Restoration, sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-10.

Primary conditionTooth AttritionRegistry: Tooth WearReclassifiedWhy we changed it

Registry

Tooth Wear — the first condition term the registry derived for this study.

ClinicalTrials.gg

Tooth Attrition

Why

The study's listed conditions name Tooth Attrition, a narrower term within Tooth Wear.

Confidence

High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →

Wrong?

Tell us the study's main condition →

Sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Observational

The sponsor has not verified this record recently (last verified Aug 2018), so the status shown — last known as Active, not recruiting — may be out of date.

Study type: Observational
Model: Other
Time perspective: Prospective
Enrollment: 33
Ages: 18 Years and older
Sex: All

Study 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 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 studied

Wear, Tooth
Wear, Occlusal
Wear, Restoration

Browse trials for

Tooth Wear 62Registry's first term
Tooth Attrition 14Primary · reclassified

Keywords

oral impressions
glassionomer cements
dental restorations
dental wear

In context

Tooth Attrition Reclassified

14 studies on the registry are indexed under Tooth Attrition; 5 are open to participants now.

Browse Tooth Attrition studies →

Lead sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio is the lead sponsor of 160 studies on the registry; 59 are open to participants now.

Browse I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio studies →

Compared within Tooth Attrition, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Tooth Wear. The counts are of registry records indexed under each term, refreshed daily. How we classify →

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes
Sampling method: Non-probability sample

Study population

Subjects are recruit from patients that undergo a dental restorations independently from the present study

Eligibility criteria

Inclusion Criteria:

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 signed and dated prior to entering the study.

Exclusion Criteria:

Inclusion and exclusion criteria

Inclusion criteria

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.

Exclusion criteria

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.
Severe bruxism.
Subject with 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

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Study design

Observational model: Other
Time perspective: Prospective
Enrollment: 33 participants (actual)
Patient registry: No

Groups and cohorts

Patients that undergo a dental restorations
Patients that undergo a dental restorations independently from the present study
Other: impression

Interventions

Otherimpression
common polyvinylsiloxane oral impression

What researchers measure

Primary outcomes

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.
Time frame: 5 years

Secondary outcomes

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.
Time frame: 5 years

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Started Feb 2016 (actual). Primary completion is estimated for Feb 2021, 60 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 13, 2018
First posted: Aug 10, 2018
StartActual: Feb 1, 2016
Primary completionEst.: Feb 1, 2021
CompletionEst.: Nov 16, 2021
Last update: Aug 10, 2018

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Aug 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03624894
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Responsible party: Sponsor
First posted: Aug 10, 2018
Start date: Feb 1, 2016
Primary completion: Feb 1, 2021 (estimated)
Completion: Nov 16, 2021 (estimated)
Last update: Aug 10, 2018

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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