Natural Dentition, Prosthesis and Antagonist Wear 3D Analysis

NCT05637619 | Recruiting

• 1 other identifier: ||2022-11
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Wear, Tooth; Dental Prosthesis Complication; Wear, Occlusal

Keywords

Tooth wear; Full arch Implant; 3D scanner; Prosthesis; Screw retained; Zirconia; Hybrid Acrylic

Outcome Measures

Primary Outcomes (1)

• Wear of teeth and materials of restorations

  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.

  at least 12 months follow-up

Secondary Outcomes (1)

• Wear of different antagonists

  at least 12 months follow-up

Study Arms (3)

Dentate Patients

Patients with natural dentition - maxilla and mandible

Behavioral: Dentate Patients

Zirconia

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

Device: Monolithic Zirconia

Hybrid Acrylic

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

Device: Hybrid-Acrylic

Interventions

Monolithic Zirconia DEVICE

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

Zirconia

Hybrid-Acrylic DEVICE

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

Hybrid Acrylic

Dentate Patients BEHAVIORAL

Dentate Patients with natural dentition or tooth supported crowns

Dentate Patients

Eligibility Criteria

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

Study Population

Control Group: Healthy Patients, Dentate Experimental Groups : Patients from a dental office that did a full-mouth (maxilla or mandible) implant-supported rehabilitation and made the final rehabilitation in either monolithic zirconia or hybrid-acrylic material

You may qualify if:

• fully dentate (with at least 10 teeth ) and do not have any tooth mobility;
• at least 12months follow up

You may not qualify if:

• \- missing more than 4 teeth, extensive caries, bonded orthodontic brackets
• Edentulous Group:
• Maxilla or Mandible Implant full-mouth implant restoration
• Monolithic ceramic or hybrid-acrylic restoration
• at least12 months Follow-up
• Heavy bruxists
• Patients that changed the full arch rehabilitation during the study (ex: framework fracture or lab reparation)

Sponsors & Collaborators

• Implantology Institute: lead

Study Sites (1)

Artur Simões

Lisbon, 1070-061, Portugal

RECRUITING

MeSH Terms

Conditions

Tooth Wear; Tooth Attrition

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• João M Caramês, Phd

  Implantology Institute

  STUDY DIRECTOR

• Duarte N Marques, Phd

  Implantology Institute

  STUDY DIRECTOR

• Artur F Simões, Msc

  Implantology Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 24, 2022
• First Posted: December 5, 2022
• Study Start: January 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 26, 2024

Record last verified: 2024-07

Locations

PT (1)