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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-01

Study Completion Date

2021-11-16

Brief Summary

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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.

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Detailed Description

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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

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Wear, Tooth Wear, Occlusal Wear, Restoration

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients that undergo a dental restorations

Patients that undergo a dental restorations independently from the present study

impression

Intervention Type OTHER

common polyvinylsiloxane oral impression

Interventions

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impression

common polyvinylsiloxane oral impression

Intervention Type OTHER

Eligibility Criteria

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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.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes