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

NCT03624894 | Unknown DMC

• 1 other identifier: GIC
• Study Type: observational
• Target: 33
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Wear, Tooth; Wear, Occlusal; Wear, Restoration

Keywords

oral impressions; glassionomer cements; dental restorations; dental wear

Outcome Measures

Primary Outcomes (1)

• 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.

  5 years

Secondary Outcomes (1)

• Level of wear of different restorative materials

  5 years

Study Arms (1)

Patients that undergo a dental restorations

Patients that undergo a dental restorations independently from the present study

Other: impression

Interventions

impression OTHER

common polyvinylsiloxane oral impression

Patients that undergo a dental restorations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

MeSH Terms

Conditions

Tooth Wear; Tooth Attrition

Interventions

Inosine Monophosphate

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Inosine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: August 10, 2018
• Study Start: February 1, 2016
• Primary Completion: February 1, 2021
• Study Completion: November 16, 2021
• Last Updated: August 10, 2018

Record last verified: 2018-08