Wear, ToothNCT05637619
Natural Dentition, Prosthesis and Antagonist Wear 3D Analysis
An observational study of Wear, Tooth and Dental Prosthesis Complication, run by Implantology Institute at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wear, Tooth, Dental Prosthesis Complication, Wear, Occlusal
- What is being tested?
- Monolithic Zirconia, Hybrid-Acrylic and Dentate Patients
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 36 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jan 2022to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Artur Simões
Lisbon, 1070-061
Artur Simões, 217210980, artursimoes@institutoimplantologia.com
Marta Nuncio, 21 721 0980
About this study
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.
Read the 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.
- Conditions
- Wear, Tooth, Dental Prosthesis Complication, Wear, Occlusal
- Being tested
- Monolithic Zirconia, Hybrid-Acrylic, Dentate Patients
- Keywords
- Tooth wear, Full arch Implant, 3D scanner, Prosthesis, Screw retained, Zirconia, Hybrid Acrylic
- Medical subject headings
- Tooth Wear, Tooth Attrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monolithic ZirconiaDevice
Maxillary or/and mandibular screw retained zirconia monolithic prostheses supported by at least 4 implants
Hybrid-AcrylicDevice
Maxillary or/and mandibular screw retained hybrid prostheses supported by at least 4 implants;
Dentate PatientsBehavioural
Dentate Patients with natural dentition or tooth supported crowns
| Study group | Role | What they receive |
|---|---|---|
| Dentate Patients | Patients with natural dentition - maxilla and mandible Receives: Behavioral: Dentate Patients | |
| Zirconia | Patients that have a full-mouth (maxilla or mandible) dental implant supported rehabilitation restored with monolithic zirconia biomaterial Receives: Device: Monolithic Zirconia | |
| Hybrid Acrylic | Patients that have a full-mouth (maxilla or mandible) dental implant supported rehabilitation restored with acrylic material (hybrid acrylic) Receives: Device: Hybrid-Acrylic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at least 12 months follow-up
Secondary outcomes (1)
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.
Measured: at least 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start1 Jan 2022
- Primary completionAug 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wear, ToothStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Implantology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- João M Caramês, Phd, Study director, Implantology InstituteDuarte N Marques, Phd, Study director, Implantology InstituteArtur F Simões, Msc, Principal investigator, Implantology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637619
- Sponsor's protocol ID
- ||2022-11
- Status last verified
- Jul 2024
- First submitted
- 24 Nov 2022
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Dentition, Prosthesis and Antagonist Wear 3D Analysis
- ClinicalTrials.gov ID
- NCT05637619
- Acronym / sponsor ID
- ||2022-11
- Conditions
- Wear, Tooth, Dental Prosthesis Complication, Wear, Occlusal
- Keywords
- Tooth wear, Full arch Implant, 3D scanner, Prosthesis, Screw retained, Zirconia, Hybrid Acrylic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Implantology InstituteUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dentate Patients | – | Behavioral: Dentate PatientsPatients with natural dentition - maxilla and mandible |
| Zirconia | – | Device: Monolithic ZirconiaPatients that have a full-mouth (maxilla or mandible) dental implant supported rehabilitation restored with monolithic zirconia biomaterial |
| Hybrid Acrylic | – | Device: Hybrid-AcrylicPatients that have a full-mouth (maxilla or mandible) dental implant supported rehabilitation restored with acrylic material (hybrid acrylic) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- missing more than 4 teeth, extensive caries, bonded orthodontic brackets
- Heavy bruxists
- Patients that changed the full arch rehabilitation during the study (ex: framework fracture or lab reparation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monolithic ZirconiaMaxillary or/and mandibular screw retained zirconia monolithic prostheses supported by at least 4 implants | Device | Zirconia |
| Hybrid-AcrylicMaxillary or/and mandibular screw retained hybrid prostheses supported by at least 4 implants; | Device | Hybrid Acrylic |
| Dentate PatientsDentate Patients with natural dentition or tooth supported crowns | Behavioural | Dentate Patients |
Primary outcome
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.
1 secondary outcome
Wear of different antagonists
Time frame: at least 12 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
João M Caramês, Phd study director
Implantology Institute
Duarte N Marques, Phd study director
Implantology Institute
Artur F Simões, Msc principal investigator
Implantology Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wear, Tooth and Dental Prosthesis Complication, run by Implantology Institute at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wear of teeth and materials of restorations (time frame: at least 12 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.