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NCT Number: NCT05637619

Natural Dentition, Prosthesis and Antagonist Wear 3D Analysis

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Artur Simões

Lisbon, 1070-061, Portugal

Location status: Recruiting

Location contact

Artur Simões

CONTACT

[email protected]

217210980

Artur Simões, Msc

PRINCIPAL_INVESTIGATOR

Duarte Marques, Phd

PRINCIPAL_INVESTIGATOR

João Caramês, Phd

PRINCIPAL_INVESTIGATOR

Marta Nuncio

CONTACT

21 721 0980

Ricardo Pinto, Msc

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Monolithic Zirconia

Device

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

Hybrid-Acrylic

Device

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

Dentate Patients

Behavioral

Dentate Patients with natural dentition or tooth supported crowns

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Implantology Institute

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 5, 2022
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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