Prospective Clinical Trial of Onlay-carrying Patients

Clinical Performance Clinical Trial

Official title:

Prospective Clinical Trial of Onlay-carrying Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04396080
• Other study ID #: H1543943843337
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: January 1, 2025

Study information

• Verified date: March 2020
• Source: University of Valencia
• Contact: Naia Bustamante Hernández, Máster
• Phone: 656744798
• Email: naiabustamante[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Clinical Performance
• Success
• Survival Rate

Intervention

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.

Locations

Country	Name	City	State
Spain	Lucia Fernandez-Estevan	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical behaviour	Analyze clinical behavior taking into account possible variables that may influence using modified UPSHS criteria	Through study completion, an average of 5 years.
Primary	Survival	Analyze the survival over time of this type of treatment	Through study completion, an average of 5 years.
Secondary	Complications	Analyze complications over time of this type of treatment using modified UPSHS criteria	Through study completion, an average of 5 years.