- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03624894
Intraoral Impressions for Assessment of Wear of Teeth and Restorative Materials. (GIC)
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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:
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 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients that undergo a dental restorations
Patients that undergo a dental restorations independently from the present study
|
common polyvinylsiloxane oral impression
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Level of wear of different restorative materials
Time Frame: 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.
|
5 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GIC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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