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
About this trial
This is an interventional treatment trial for Adhesion
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)
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
NCT ID
NCT03443583
First Posted
February 18, 2018
Last Updated
February 23, 2018
Sponsor
University Medical Center Groningen
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
Learn more about this trial
Immediate and Delayed Dentin Sealing Effect on Partial Crowns
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