CClinicalTrials.gg
Status unknownNCT04396080Updated May 20, 2020

Prospective Clinical Trial of Onlay-carrying Patients

An interventional study of Partial restoration in posterior teeth in Success, Survival Rate and Clinical Performance, sponsored by University of Valencia. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-20.

Sponsored by University of Valencia · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Jan 2019, registered May 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.
02

Conditions studied

  • Success
  • Survival Rate
  • Clinical Performance
03

In context

Lead sponsor

University of Valencia is the lead sponsor of 349 studies on the registry; 73 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  • Inclusion criteria:
  • 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)

Exclusion Criteria:

  • Minor patients.
  • Medically committed patients.
  • Patients with active cavities.
  • Patients with active periodontal disease.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Onlays behaviour depending on materials

    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.

    Procedure: Partial restoration in posterior teeth

Interventions

  • ProcedurePartial restoration in posterior teeth

    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.

06

What researchers measure

Primary outcomes

  1. Survival

    Analyze the survival over time of this type of treatment

    Time frame: 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

    Time frame: Through study completion, an average of 5 years.

Other outcomes

  1. Clinical behaviour

    Analyze clinical behavior taking into account possible variables that may influence using modified UPSHS criteria

    Time frame: Through study completion, an average of 5 years.

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04396080
Lead sponsor
University of Valencia
Responsible party
Sponsor
First posted
May 20, 2020
Start date
Jan 1, 2019
Primary completion
Jan 1, 2024 (estimated)
Completion
Jan 1, 2025 (estimated)
Last update
May 20, 2020

Study contacts

Naia Bustamante Hernández, Máster
Contact
naiabustamante@gmail.com
656744798
Lucia Fernandez-Estevan, Doctor
principal investigator · University of Valencia

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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