SuccessNCT04396080
Prospective Clinical Trial of Onlay-carrying Patients
A study testing Partial restoration in posterior teeth in people with Success and Survival Rate, run by University of Valencia at 1 site in Spain.
Trial summary
A record of the type of onlay will be made with respect to its extension, tooth or teeth to be treated, the material of clothing and the substrate on which the adhesion and cementing method, as well as the type of antagonist. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Success, Survival Rate, Clinical Performance
- What is being tested?
- Partial restoration in posterior teeth
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2019to 1 Jan 2025
- Phase
- Interventional
- 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
Who may be able to join
- Healthy adult patients (ASA I) susceptible to treatment with onlays in the posterior region treated at the University Dental Clinic (Master's Clinic in Dental Prosthetics of the Department of Stomatology of the Faculty of Medicine and dentistry)
Who cannot join
- Minor patients.
- Medically committed patients.
- Patients with active cavities.
- Patients with active periodontal disease.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Lucia Fernandez-Estevan
Valencia, 46010
Lucia Fernandez-Estevan, Doctor, lucia.fernandez-estevan@uv.es
About this study
A record of the type of onlay will be made with respect to its extension, tooth or teeth to be treated, the material of clothing and the substrate on which the adhesion and cementing method, as well as the type of antagonist. To complete it, a complete clinical oral examination will be performed with oral mirrors, examination probes, joint paper, disposable gloves, masks, paper napkins, plastic cups, dental equipment lighting lamp, cold spray , photogrammed camera, including an intraoral scan to have a 3D file of the patient's condition on the day of embedding placement.
Once treatment is complete, the patient should go to routine check-ups in which a full intraoral exploration and data collection intended to be carried out analyze the following variables (USPHS modificated): possible decemented and fractured, decay and marginal integrity, sensitivity or loss of vitality, as well as the degree of patient satisfaction (VAS).
Read the detailed description
The same intervention will be carried out during the duration of the project, collecting the variables:
- baseline recall. (cementing day)
- 1 month.
- 6 months.
- annually.
- Conditions
- Success, Survival Rate, Clinical Performance
- Being tested
- Partial restoration in posterior teeth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial restoration in posterior teethProcedure or surgery
Teeth in need of onlays that will be treated with this type of treatment, choosing the most suitable material for each patient and following the manufacturer's instructions for their cementing and adhesion.
| Study group | Role | What they receive |
|---|---|---|
| Onlays behaviour depending on materials | Experimental | Patients who require it as treatment option will be treated with posterior partial restorations, and will have clinical follow-up to obtain a comparison of the behavior of subsequent restorations based on the material. Receives: Procedure: Partial restoration in posterior teeth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Analyze the survival over time of this type of treatment
Measured: Through study completion, an average of 5 years.
Secondary outcomes (1)
Complications
Analyze complications over time of this type of treatment using modified UPSHS criteria
Measured: Through study completion, an average of 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start1 Jan 2019
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuccessStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients who require it, will be treated with posterior partial restorations. That will be the intervention.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucia Fernandez-Estevan, Doctor, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396080
- Sponsor's protocol ID
- H1543943843337
- Status last verified
- Mar 2020
- First submitted
- 11 May 2020
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Trial of Onlay-carrying Patients
- ClinicalTrials.gov ID
- NCT04396080
- Acronym / sponsor ID
- H1543943843337
- Conditions
- Success, Survival Rate, Clinical Performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 20 May 2020 (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.
A record of the type of onlay will be made with respect to its extension, tooth or teeth to be treated, the material of clothing and the substrate on which the adhesion and cementing method, as well as the type of antagonist. To complete it, a complete clinical oral examination will be performed with oral mirrors, examination probes, joint paper, disposable gloves, masks, paper napkins, plastic cups, dental equipment lighting lamp, cold spray , photogrammed camera, including an intraoral scan to have a 3D file of the patient's condition on the day of embedding placement.
Once treatment is complete, the patient should go to routine check-ups in which a full intraoral exploration and data collection intended to be carried out analyze the following variables (USPHS modificated): possible decemented and fractured, decay and marginal integrity, sensitivity or loss of vitality, as well as the degree of patient satisfaction (VAS).
Detailed description
The same intervention will be carried out during the duration of the project, collecting the variables:
- baseline recall. (cementing day)
- 1 month.
- 6 months.
- annually.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients who require it, will be treated with posterior partial restorations. That will be the intervention.
| Arm | Type | Receives |
|---|---|---|
| Onlays behaviour depending on materials | Experimental | Procedure: Partial restoration in posterior teethPatients who require it as treatment option will be treated with posterior partial restorations, and will have clinical follow-up to obtain a comparison of the behavior of subsequent restorations based on the material. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adult patients (ASA I) susceptible to treatment with onlays in the posterior region treated at the University Dental Clinic (Master's Clinic in Dental Prosthetics of the Department of Stomatology of the Faculty of Medicine and dentistry)
Key exclusion criteria (4 listed)
- Minor patients.
- Medically committed patients.
- Patients with active cavities.
- Patients with active periodontal disease.
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 restoration in posterior teethTeeth in need of onlays that will be treated with this type of treatment, choosing the most suitable material for each patient and following the manufacturer's instructions for their cementing and adhesion. | Procedure or surgery | Onlays behaviour depending on materials |
Primary outcome
Survival
Time frame: Through study completion, an average of 5 years.
Analyze the survival over time of this type of treatment
1 secondary outcome
Complications
Time frame: Through study completion, an average of 5 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
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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.
Lucia Fernandez-Estevan, Doctor principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partial restoration in posterior teeth in people with Success and Survival Rate, run by University of Valencia at 1 site in Spain.
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 1 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 20 May 2020. 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 Spain. 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 Naia Bustamante Hernández, Máster (656744798, naiabustamante@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: Through study completion, an average of 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 20 May 2020.