Prospective Clinical Trial of Onlay-carrying Patients

NCT04396080 | Unknown DMC

• 1 other identifier: H1543943843337
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Success; Survival Rate; Clinical Performance

Outcome Measures

Primary Outcomes (1)

• Survival

  Analyze the survival over time of this type of treatment

  Through study completion, an average of 5 years.

Secondary Outcomes (1)

• Complications

  Through study completion, an average of 5 years.

Other Outcomes (1)

• Clinical behaviour

  Through study completion, an average of 5 years.

Study Arms (1)

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.

Procedure: Partial restoration in posterior teeth

Interventions

Partial restoration in posterior teeth PROCEDURE

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.

Onlays behaviour depending on materials

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Lucia Fernandez-Estevan

Valencia, 46010, Spain

RECRUITING

Study Officials

• Lucia Fernandez-Estevan, Doctor

  University of Valencia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naia Bustamante Hernández, Máster

CONTACT

656744798; naiabustamante@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients who require it, will be treated with posterior partial restorations. That will be the intervention.

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 20, 2020
• Study Start: January 1, 2019
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2025
• Last Updated: May 20, 2020

Record last verified: 2020-03

Locations

ES (1)