Immediate and Delayed Dentin Sealing Effect on Partial Crowns

Prospective Randomized Clinical Trial on the Survival and Quality of Survival of Lithium Disilicate Posterior Partial Crowns Bonded Using Immediate or Delayed Dentin Sealing a 3- Year Follow up

Immediate Dentin Sealing as an adjunct to adhesive cementation of all ceramic restorations is proposed and executed in several studies, but there is very limited evidence to support its effectiveness. It is presumed that IDS both reduces postoperative sensitivity and increases the bond strength to dentin as compared to DDS.

Study Overview

• Status: Completed
• Conditions: Adhesion; Tooth; Crown; Luting; Immediate Dentin Sealing
• Intervention / Treatment: Other: Immediate Dentin Sealing or Delayed Dentin Sealing

Detailed Description

Micromechanical and chemical retention of ceramic fixed prosthesis to tooth structure introduced minimal invasive preparation to dentistry. As a result, biomechanically or aesthetically compromised teeth can be restored at a lower biological price, saving sound tooth tissues. A slow but steady (mind) shift from full metal and metal-ceramic restorations that require conventional cementation and substantial tooth loss (Edelhoff en Sorensen, 2002) to less destructive partial all ceramic restorations that require adhesive cementation is seen in the clinical field.

The clinical success of ceramic restorations relies heavily on the quality of their adhesion to dentin, which remains a clinical challenge to date. Improvements in this field over the years have brought about better cements and more effective methods to condition both substrates and teeth.

Immediate Dentin Sealing (IDS) is a technique that presumably improves adhesion of ceramic fixed prosthesis to tooth structure which results in a better marginal adaptation to dentin and less postoperative sensitivity compared to conventional adhesive cementation, also referred to as Delayed Dentin Sealing (DDS).(Pashley et al, 1992; Paul en Scharer, 1997; Magne et al, 2005; Magne et al, 2007; Breschi et al, 2008; Lee en Park, 2009). The main difference between the IDS and DDS technique lies in the fact that in IDS, a thin layer of bonding resin is applied immediately after tooth preparation and prior to impression taking, whereas in DDS this layer is applied immediately before cementation of the restoration. At first glance this may appear a minor difference, but it is presumed to be of major clinical importance. The effectiveness of IDS is studied as an adjunct to conventional adhesive cementation of ceramic indirect restorations. A split mouth clinical trial comparing ceramic restorations cemented with either IDS or DDS after one year of clinical service is executed. For each patient two all ceramic indirect restorations are made. One is cemented by means of DDS (control group) and the other one is cemented by means of IDS (experimental group). Clinical evaluation is performed shortly after cementation and after 1 and 3 year(s) of clinical function.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients should be over 18 years of age, in reasonable to good general health, as expressed by an ASA-score I or II (de Jong and Abraham-Inpijn, 1994).This ASA-score is already known before participation, due to regular check-ups;
• Patients should have an indication for at least two indirect ceramic restorations on vital teeth.

Exclusion Criteria:

• ASA-score III or higher;
• Hypersensitivity of the tooth which has to be restorated. This is measured before inclusion. (Is measured with a cotton pallet and cold spray which are hold to the tooth. If the tooth is painful and is doesn't relief from pain quickly the tooth is hypersensitive)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	Survival of the restorations	3 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of the restorations	Criteria according to Hickel and USPHS	3 year

Collaborators and Investigators

• Sponsor: University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2013
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: February 18, 2018
• First Submitted That Met QC Criteria: February 18, 2018
• First Posted (Actual): February 23, 2018

Study Record Updates

• Last Update Posted (Actual): February 27, 2018
• Last Update Submitted That Met QC Criteria: February 23, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: NL45130

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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