Natural Dentition, Prosthesis and Antagonist Wear 3D Analysis

December 6, 2022 updated by: Implantology Institute

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Lisboa, Portugal, 1070-061
        • Recruiting
        • Artur Simões
        • Principal Investigator:
          • Artur Simões, Msc
        • Contact:
        • Contact:
          • Marta Nuncio
          • Phone Number: 21 721 0980
        • Principal Investigator:
          • Duarte Marques, Phd
        • Principal Investigator:
          • Ricardo Pinto, Msc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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

Description

Dentate Group :

Inclusion criteria

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

Exclusion criteria

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

Edentulous Group:

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wear of teeth and materials of restorations
Time Frame: 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.
at least 12 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wear of different antagonists
Time Frame: 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.
at least 12 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Implantology Institute

Investigators

  • Study Director: João M Caramês, Phd, Implantology Institute
  • Study Director: Duarte N Marques, Phd, Implantology Institute
  • Principal Investigator: Artur F Simões, Msc, Implantology Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

November 24, 2022

First Submitted That Met QC Criteria

November 24, 2022

First Posted (Actual)

December 5, 2022

Study Record Updates

Last Update Posted (Estimate)

December 8, 2022

Last Update Submitted That Met QC Criteria

December 6, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ||2022-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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