Natural Dentition, Prosthesis and Antagonist Wear 3D Analysis

Sponsor

Implantology Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT05637619

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Wear resistance is one of the most important physical properties of teeth, and wear resistance of zirconia against artificial acrylic, enamel and composite resin denture teeth has not been clearly established.

Implant-supported dental restorations present a higher threshold for occlusion perception when compared to natural teeth, which can occlusal overload mechanisms or lead to wear of rehabilitation materials or the antagonist arch.

In clinical conditions, however, many other factors influence the complex interaction between dental enamel and opposing substrates: patient-related factors such as dietary habits, dysfunctional occlusion, masticatory forces, and bruxism contribute to accelerated enamel loss of antagonist teeth.

Condition or Disease	Intervention/Treatment	Phase
Wear, Tooth Dental Prosthesis Complication Wear, Occlusal	Device: Monolithic Zirconia Device: Hybrid-Acrylic Behavioral: Dentate Patients

Detailed Description

It will be our intention to perform a prospective study and proof-of-concept to assess wear in natural dentition, Full arch implant supported rehabilitation (FAISR) and opposing arches. Wear according to type of rehabilitation and of opposing arch, technical complications, parafunction and number of placed implants will be assessed.

Intra-oral digital acquisition will be performed at pre-defined intervals. Changes over time will be assessed through a previously described digital superimposition methodology volumetric changes determined.

Patients will be scanned using an intraoral dental scanner (T0)

Patients will be recalled at every 4-months (T1), 8-months (T2) and 12-months (T3) visits for re-scanning and from there every 6-months

Scanned images will be compared using a metrology software to determine maximum vertical wear of teeth and root mean square wear.

Study Design

Study Type:

Observational

Anticipated Enrollment :

36 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Natural Dentition, Prosthesis and Antagonist Wear 3D Analysis

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Dentate Patients Patients with natural dentition - maxilla and mandible	Behavioral: Dentate Patients Dentate Patients with natural dentition or tooth supported crowns
Zirconia Patients that have a full-mouth (maxilla or mandible) dental implant supported rehabilitation restored with monolithic zirconia biomaterial	Device: Monolithic Zirconia Maxillary or/and mandibular screw retained zirconia monolithic prostheses supported by at least 4 implants
Hybrid Acrylic Patients that have a full-mouth (maxilla or mandible) dental implant supported rehabilitation restored with acrylic material (hybrid acrylic)	Device: Hybrid-Acrylic Maxillary or/and mandibular screw retained hybrid prostheses supported by at least 4 implants;

Arm

Intervention/Treatment

Dentate Patients

Patients with natural dentition - maxilla and mandible

Behavioral: Dentate Patients

Dentate Patients with natural dentition or tooth supported crowns

Zirconia

Patients that have a full-mouth (maxilla or mandible) dental implant supported rehabilitation restored with monolithic zirconia biomaterial

Device: Monolithic Zirconia

Maxillary or/and mandibular screw retained zirconia monolithic prostheses supported by at least 4 implants

Hybrid Acrylic

Patients that have a full-mouth (maxilla or mandible) dental implant supported rehabilitation restored with acrylic material (hybrid acrylic)

Device: Hybrid-Acrylic

Maxillary or/and mandibular screw retained hybrid prostheses supported by at least 4 implants;

Outcome Measures

Primary Outcome Measures

Wear of teeth and materials of restorations [at least 12 months follow-up]
Measure in different groups occlusal tooth wear from insertion (baseline) to 4, 8 and 12 months post-insertion Scanned images will be compared using a metrology software to determine maximum vertical wear of teeth and root mean square wear.

Secondary Outcome Measures

Wear of different antagonists [at least 12 months follow-up]
Measure occlusal tooth wear of antagonists from insertion (baseline) to 4, 8 and 12 months post-insertion Scanned images will be compared using a metrology software to determine maximum vertical wear of teeth and root mean square wear.