Natural Dentition, Prosthesis and Antagonist Wear 3D Analysis

NCT ID: NCT05637619

Last Updated: 2024-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Wear, Tooth Dental Prosthesis Complication Wear, Occlusal

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Dentate Patients

Patients with natural dentition - maxilla and mandible

Dentate Patients

Intervention Type BEHAVIORAL

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

Monolithic Zirconia

Intervention Type DEVICE

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)

Hybrid-Acrylic

Intervention Type DEVICE

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

Interventions

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Monolithic Zirconia

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

Intervention Type DEVICE

Hybrid-Acrylic

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

Intervention Type DEVICE

Dentate Patients

Dentate Patients with natural dentition or tooth supported crowns

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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


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

Exclusion Criteria

\- missing more than 4 teeth, extensive caries, bonded orthodontic brackets

Edentulous Group:


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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Implantology Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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João M Caramês, Phd

Role: STUDY_DIRECTOR

Implantology Institute

Duarte N Marques, Phd

Role: STUDY_DIRECTOR

Implantology Institute

Artur F Simões, Msc

Role: PRINCIPAL_INVESTIGATOR

Implantology Institute

Locations

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Artur Simões

Lisbon, , Portugal

Site Status RECRUITING

Countries

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Portugal

Facility Contacts

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Artur Simões

Role: primary

217210980

Marta Nuncio

Role: backup

21 721 0980

Other Identifiers

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||2022-11

Identifier Type: -

Identifier Source: org_study_id

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