Partial Indirect RestorationNCT05265559
Influence of Operator Factors on Succes and Survival of Indirect Restorations
An observational study of Partial Indirect Restoration and Clinical Study, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Background: Nowadays, tissue preserving, aesthetically high-quality and sustainable dentistry is more and more becoming the standard way of treatment. To reach those standards, one of the treatment options is applying a partial indirect restoration made by glass ceramics using immediate dental sealing (IDS). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Partial Indirect Restoration, Clinical Study, Adhesion
- What is being tested?
- Partial Indirect Restoration
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Oct 2018to 1 Jul 2025
- How long will I take part?
- 5 Years
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Ten different dentists will ask patients (who have been indicated and agreed to have an indirect restoration) if they would like to be part of this study. Taking possible drop-out into account, the practitioners are asked to include twenty patients each (total n=200).
Who may be able to join
- Healthy individuals
- Adults
Who cannot join
- Periodontal unstable situation
- Endodontic unstable situation
- Allergies for one or more of the used products
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9713GZ
M.M.M. Gresnigt, M.D.
About this study
Official title: Multicenter Prospective Clinical Trial of Partial Ceramic Posterior Restorations Using Immediate Dentin Sealing - The Infuence of Operator Factors on Success and Survival
Background: Nowadays, tissue preserving, aesthetically high-quality and sustainable dentistry is more and more becoming the standard way of treatment. To reach those standards, one of the treatment options is applying a partial indirect restoration made by glass ceramics using immediate dental sealing (IDS). Using IDS, a protocol is followed to applicate a dentin bonding agent to freshly cut dentin when it is exposed during tooth preparation for indirect restorations (inlays/onlays, crowns). The preparation made for partial restorations is minimal invasive. Glass ceramic restorations have very high survival rates (90 to 100% after five years) (Morimoto et al., 2016) and glass ceramic mimics the color and structure of the tooth very well.
This kind of treatment is gaining interest and increasingly applied however little information is available on the long-term effects when multiple general practitioners apply these restorations.
Read more
Objectives: The main goal of this study is to evaluate partial posterior ceramic restorations with the application of an immediate dentin sealing (IDS) performed by various practitioners.
Study design and population:
Twenty dental practitioners, who followed a course on making ceramic partial restorations using IDS, will be asked to include patients for this study. The dental practitioners are being asked to share their data (occlusal light photo's, impression and x-rays) of twenty-five restorations they make after having the course. Restorations of individuals with a minimum age of 18 will be included. The information from pictures and impressions will be evaluated.
Items to evaluate
The practitioners will be interviewed to get to know in what circumstances they do their treatment. Items that are discussed are:
- using rubber dam;
- using magnification by means of loupes/microscope;
- scheduled time for the treatment;
- number of restorations after following the course.
Initial data (gathered directly after treatment) will be evaluated looking at:
- surface of preparation after IDS;
- size of the prepared surface;
- color.
Follow up data will be evaluated looking at:
- tooth extraction
- fracture restoration
- fracture tooth
- secondairy caries
- de-bonding
- endodontic problems
Outcome: Failures (fracture, de-bonding, secondairy cariës, endodontic problems) are the main outcome measurements.
Description and estimation of the load and risk for the subjects:
No extra intervention is performed. The dental practitioners will provide their data (i.e. impressions, occlusal light photo's) and these will be evaluated by the researchers. Follow up data will be gathered from X-rays already made for periodical oral examination (taking the caries risk into account). Summarizing, there is no extra load or risk for the patients.
Studie design Prospective practice-based research, multicenter.
- Conditions
- Partial Indirect Restoration, Clinical Study, Adhesion, Immediate Dentin Sealing, Posterior Region, Operator Factors
- Being tested
- Partial Indirect Restoration
- Medical subject headings
- Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial Indirect RestorationProcedure or surgery
Dental restorative treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival and Succes
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start9 Oct 2018
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial Indirect RestorationStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265559
- Sponsor's protocol ID
- 201800678
- Status last verified
- Feb 2022
- First submitted
- 22 Feb 2022
- Last updated
- 3 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Clinical Trial of Partial Ceramic Posterior Restorations Using Immediate Dentin Sealing - The Infuence of Operator Factors on Success and Survival
- ClinicalTrials.gov ID
- NCT05265559
- Acronym / sponsor ID
- 201800678
- Conditions
- Partial Indirect Restoration, Clinical Study, Adhesion, Immediate Dentin Sealing, Posterior Region, Operator Factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 3 Mar 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.
Background: Nowadays, tissue preserving, aesthetically high-quality and sustainable dentistry is more and more becoming the standard way of treatment. To reach those standards, one of the treatment options is applying a partial indirect restoration made by glass ceramics using immediate dental sealing (IDS). Using IDS, a protocol is followed to applicate a dentin bonding agent to freshly cut dentin when it is exposed during tooth preparation for indirect restorations (inlays/onlays, crowns). The preparation made for partial restorations is minimal invasive. Glass ceramic restorations have very high survival rates (90 to 100% after five years) (Morimoto et al., 2016) and glass ceramic mimics the color and structure of the tooth very well.
This kind of treatment is gaining interest and increasingly applied however little information is available on the long-term effects when multiple general practitioners apply these restorations.
Objectives: The main goal of this study is to evaluate partial posterior ceramic restorations with the application of an immediate dentin sealing (IDS) performed by various practitioners.
Study design and population:
Twenty dental practitioners, who followed a course on making ceramic partial restorations using IDS, will be asked to include patients for this study. The dental practitioners are being asked to share their data (occlusal light photo's, impression and x-rays) of twenty-five restorations they make after having the course. Restorations of individuals with a minimum age of 18 will be included. The information from pictures and impressions will be evaluated.
Items to evaluate
The practitioners will be interviewed to get to know in what circumstances they do their treatment. Items that are discussed are:
- using rubber dam;
- using magnification by means of loupes/microscope;
- scheduled time for the treatment;
- number of restorations after following the course.
Initial data (gathered directly after treatment) will be evaluated looking at:
- surface of preparation after IDS;
- size of the prepared surface;
- color.
Follow up data will be evaluated looking at:
- tooth extraction
- fracture restoration
- fracture tooth
- secondairy caries
- de-bonding
- endodontic problems
Outcome: Failures (fracture, de-bonding, secondairy cariës, endodontic problems) are the main outcome measurements.
Description and estimation of the load and risk for the subjects:
No extra intervention is performed. The dental practitioners will provide their data (i.e. impressions, occlusal light photo's) and these will be evaluated by the researchers. Follow up data will be gathered from X-rays already made for periodical oral examination (taking the caries risk into account). Summarizing, there is no extra load or risk for the patients.
Studie design Prospective practice-based research, multicenter.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ten different dentists will ask patients (who have been indicated and agreed to have an indirect restoration) if they would like to be part of this study. Taking possible drop-out into account, the practitioners are asked to include twenty patients each (total n=200).
Key inclusion criteria (2 listed)
- Healthy individuals
- Adults
Key exclusion criteria (3 listed)
- Periodontal unstable situation
- Endodontic unstable situation
- Allergies for one or more of the used products
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 |
|---|---|---|
| Partial Indirect RestorationDental restorative treatment | Procedure or surgery | – |
Primary outcome
Survival and Succes
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Partial Indirect Restoration
Recruiting
Milled vs 3D-Printed Partial-Coverage Restorations in Endodontically Treated Molars
Endodontically Treated Teeth
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.
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 Partial Indirect Restoration and Clinical Study, run by University Medical Center Groningen at 1 site in Netherlands.
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 2 inclusion and 3 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 3 Mar 2022. 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 Netherlands. 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?
Contact M.M.M. Gresnigt, M.D. (+31647494611, marcogresnigt@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival and Succes (time frame: 5 years). 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 3 Mar 2022.