Influence of Operator Factors on Succes and Survival of Indirect Restorations

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

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.

Study Overview

• Status: Recruiting
• Conditions: Adhesion; Clinical Study; Immediate Dentin Sealing; Partial Indirect Restoration; Posterior Region; Operator Factors
• Intervention / Treatment: Procedure: Partial Indirect Restoration

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: M.M.M. Gresnigt, M.D.; Phone Number: +31647494611; Email: marcogresnigt@yahoo.com

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713GZ
    • Recruiting
    • University Medical Center Groningen
    • Contact: M.M.M. Gresnigt, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Ten different dentists will ask patients (who have been indicated and agreed to have an indirect restoration) if they would like to be part of this study. Taking possible drop-out into account, the practitioners are asked to include twenty patients each (total n=200).

Description

Inclusion Criteria:

• Healthy individuals
• Adults

Exclusion Criteria:

• Periodontal unstable situation
• Endodontic unstable situation
• Allergies for one or more of the used products

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Survival and Succes	5 years

Collaborators and Investigators

• Sponsor: University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2018
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): July 1, 2025

Study Registration Dates

• First Submitted: February 22, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): March 3, 2022
• Last Update Submitted That Met QC Criteria: March 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: 201800678

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No