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Immediate and Delayed Dentin Sealing Effect on Partial Crowns

Primary Purpose

Adhesion, Tooth, Crown

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Immediate Dentin Sealing or Delayed Dentin Sealing
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Survival
    Survival of the restorations

    Secondary Outcome Measures

    Quality of the restorations
    Criteria according to Hickel and USPHS

    Full Information

    First Posted
    February 18, 2018
    Last Updated
    February 23, 2018
    Sponsor
    University Medical Center Groningen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03443583
    Brief Title
    Immediate and Delayed Dentin Sealing Effect on Partial Crowns
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1, 2013 (Actual)
    Primary Completion Date
    February 1, 2018 (Actual)
    Study Completion Date
    February 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Medical Center Groningen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adhesion, Tooth, Crown, Luting, Immediate Dentin Sealing

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    A split mouth clinical trial comparing ceramic restorations cemented with either IDS or DDS after one year of three years of clinical service.
    Masking
    Participant
    Masking Description
    Only the participant does not know which treatment is used on which teeth. The care provider and investigator have to know because different treatment protocol steps that have to be taken.
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Other
    Intervention Name(s)
    Immediate Dentin Sealing or Delayed Dentin Sealing
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Survival
    Description
    Survival of the restorations
    Time Frame
    3 year
    Secondary Outcome Measure Information:
    Title
    Quality of the restorations
    Description
    Criteria according to Hickel and USPHS
    Time Frame
    3 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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)

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Immediate and Delayed Dentin Sealing Effect on Partial Crowns

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