Influence of Operator Factors on Succes and Survival of Indirect Restorations

Adhesion Clinical Trial

Official title:

Multicenter Prospective Clinical Trial of Partial Ceramic Posterior Restorations Using Immediate Dentin Sealing - The Infuence of Operator Factors on Success and Survival

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05265559
• Other study ID #: 201800678
• Status: Recruiting
• Start date: October 9, 2018
• Est. completion date: July 1, 2025

Study information

• Verified date: February 2022
• Source: University Medical Center Groningen
• Contact: M.M.M. Gresnigt, M.D.
• Phone: +31647494611
• Email: marcogresnigt[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Background: Nowadays, tissue preserving, aesthetically high-quality and sustainable dentistry is more and more becoming the standard way of treatment. To reach those standards, one of the treatment options is applying a partial indirect restoration made by glass ceramics using immediate dental sealing (IDS). Using IDS, a protocol is followed to applicate a dentin bonding agent to freshly cut dentin when it is exposed during tooth preparation for indirect restorations (inlays/onlays, crowns). The preparation made for partial restorations is minimal invasive. Glass ceramic restorations have very high survival rates (90 to 100% after five years) (Morimoto et al., 2016) and glass ceramic mimics the color and structure of the tooth very well.

This kind of treatment is gaining interest and increasingly applied however little information is available on the long-term effects when multiple general practitioners apply these restorations.

Objectives: The main goal of this study is to evaluate partial posterior ceramic restorations with the application of an immediate dentin sealing (IDS) performed by various practitioners.

Study design and population:

Twenty dental practitioners, who followed a course on making ceramic partial restorations using IDS, will be asked to include patients for this study. The dental practitioners are being asked to share their data (occlusal light photo's, impression and x-rays) of twenty-five restorations they make after having the course. Restorations of individuals with a minimum age of 18 will be included. The information from pictures and impressions will be evaluated.

Items to evaluate

The practitioners will be interviewed to get to know in what circumstances they do their treatment. Items that are discussed are:

• using rubber dam;

• using magnification by means of loupes/microscope;

• scheduled time for the treatment;

• number of restorations after following the course.

Initial data (gathered directly after treatment) will be evaluated looking at:

• surface of preparation after IDS;

• size of the prepared surface;

• color.

Follow up data will be evaluated looking at:

• tooth extraction

• fracture restoration

• fracture tooth

• secondairy caries

• de-bonding

• endodontic problems

Outcome: Failures (fracture, de-bonding, secondairy cariës, endodontic problems) are the main outcome measurements.

Description and estimation of the load and risk for the subjects:

No extra intervention is performed. The dental practitioners will provide their data (i.e. impressions, occlusal light photo's) and these will be evaluated by the researchers. Follow up data will be gathered from X-rays already made for periodical oral examination (taking the caries risk into account). Summarizing, there is no extra load or risk for the patients.

Studie design Prospective practice-based research, multicenter.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 1, 2025
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy individuals

• Adults

Exclusion Criteria:

• Periodontal unstable situation

• Endodontic unstable situation

• Allergies for one or more of the used products

Related Conditions & MeSH terms

• Adhesion
• Immediate Dentin Sealing
• Tissue Adhesions

Intervention

Procedure:
• Partial Indirect Restoration
Dental restorative treatment

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival and Succes		5 years