Clinical trial NCT03624894: Intraoral Impressions for Assessment of Wear of Teeth and Restorative Materials.
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Wear, Tooth
Wear, Occlusal
Wear, Restoration
Keywords: oral impressions
glassionomer cements
dental restorations
dental wear
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects are recruit from patients that undergo a dental restorations independently from the present study

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

Eligibility criteria: 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 exclusion criteria

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

1. Subject with full dentures or crowns and bridges in occlusal contact with teeth indicated for restorative treatment.
2. Absence of occlusal contact.
3. Subject has a history of drug abuse, addiction to medication or alcohol abuse within the previous year.
4. Pulp exposure during restorative procedure or unvital teeth.
5. Known unavailability of subject for recall Visit(s).
6. Allergy to any ingredient of impression material.
7. Severe bruxism.
8. Subject with clinically significant or unstable medical or physiological condition.
9. Female subject is pregnant or lactating or intends to become pregnant during the course of the study.
10. Subject is not willing to participate in the study or not able to understand the content of the study

Primary outcomes:
measure: Wear of teeth and materials of restorations
timeFrame: 5 years
Secondary outcomes:
measure: Level of wear of different restorative materials
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
References: