Natural Dentition, Prosthesis and Antagonist Wear 3D Analysis

Wear, Occlusal Clinical Trial

Official title:

Natural Dentition, Prosthesis and Antagonist Wear 3D Analysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05637619
• Other study ID #: ||2022-11
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: December 2022
• Source: Implantology Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 2024
• Est. primary completion date: June 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dental Prosthesis Complication
• Tooth Wear
• Wear, Occlusal
• Wear, Tooth

Intervention

Device:
• Monolithic Zirconia
Maxillary or/and mandibular screw retained zirconia monolithic prostheses supported by at least 4 implants
• Hybrid-Acrylic
Maxillary or/and mandibular screw retained hybrid prostheses supported by at least 4 implants;

Behavioral:
• Dentate Patients
Dentate Patients with natural dentition or tooth supported crowns

Locations

Country	Name	City	State
Portugal	Artur Simões	Lisboa

Sponsors (1)

Lead Sponsor	Collaborator
Implantology Institute

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Wear of different antagonists	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