Natural Dentition, Prosthesis and Antagonist Wear 3D Analysis

Recruiting

• Conditions: Wear, Tooth; Wear, Occlusal; Dental Prosthesis Complication
• Interventions: Device: Monolithic Zirconia; Device: Hybrid-Acrylic; Behavioral: Dentate Patients

• Registration Number: NCT05637619
• Lead Sponsor: Implantology Institute

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.

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 Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-11-24
• Study First Submitted QC: 2022-11-24
• Study First Posted: 2022-12-05
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-26
• Primary Completion: 2024-08
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Maxilla or Mandible Implant full-mouth implant restoration
• Monolithic ceramic or hybrid-acrylic restoration
• at least12 months Follow-up

Exclusion Criteria

• Heavy bruxists
• Patients that changed the full arch rehabilitation during the study (ex: framework fracture or lab reparation)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Zirconia	Monolithic Zirconia	Patients that have a full-mouth (maxilla or mandible) dental implant supported rehabilitation restored with monolithic zirconia biomaterial
Hybrid Acrylic	Hybrid-Acrylic	Patients that have a full-mouth (maxilla or mandible) dental implant supported rehabilitation restored with acrylic material (hybrid acrylic)
Dentate Patients	Dentate Patients	Patients with natural dentition - maxilla and mandible

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Artur Simões; 🇵🇹 Lisboa, Portugal