Prospective Clinical Trial of Onlay-carrying Patients

May 15, 2020 updated by: University of Valencia

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: Through study completion, an average of 5 years.
Analyze the survival over time of this type of treatment
Through study completion, an average of 5 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: Through study completion, an average of 5 years.
Analyze complications over time of this type of treatment using modified UPSHS criteria
Through study completion, an average of 5 years.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical behaviour
Time Frame: Through study completion, an average of 5 years.
Analyze clinical behavior taking into account possible variables that may influence using modified UPSHS criteria
Through study completion, an average of 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Investigators

  • Principal Investigator: Lucia Fernandez-Estevan, Doctor, University of Valencia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

May 11, 2020

First Submitted That Met QC Criteria

May 15, 2020

First Posted (Actual)

May 20, 2020

Study Record Updates

Last Update Posted (Actual)

May 20, 2020

Last Update Submitted That Met QC Criteria

May 15, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • H1543943843337

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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