Wear, Occlusal, Wear, Restoration, Wear, Tooth
Conditions
Keywords
oral impressions, glassionomer cements, dental restorations, dental wear
Brief 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.
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
Interventions
OTHERimpression
common polyvinylsiloxane oral impression
Sponsors
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Subject ≥18 years. 2. Subjects with restorative treatments on vital teeth in posterior molar region. Will be considered at most one reconstruction per side. 3. 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). 4. Favorable and stable occlusal relationship between the remaining teeth. 5. Subject must be reliable, cooperative, and in the opinion of the Investigator, likely to be compliant with study procedures. 6. Subject provides written informed consent signed and dated prior to entering the study.
Exclusion criteria
Inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wear of teeth and materials of restorations | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of wear of different restorative materials | 5 years | 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. |
Outcome results
None listed