ClinicalTrials.gg
CompletedNCT03443583Updated Feb 27, 2018

Immediate and Delayed Dentin Sealing Effect on Partial Crowns

An interventional study of Immediate Dentin Sealing or Delayed Dentin Sealing in Adhesion, Tooth and Crown, sponsored by University Medical Center Groningen. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-27.

Sponsored by University Medical Center Groningen · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 3 months after the study started (first participant enrolled Nov 2013, registered Feb 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Adhesion
  • Tooth
  • Crown
  • Luting
  • Immediate Dentin Sealing

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03

In context

Tissue Adhesions

121 studies on the registry are indexed under Tissue Adhesions; 15 are open to participants now.

This study's enrollment of 30 is below the median of 61 across 84 interventional studies indexed under Tissue Adhesions.

Browse Tissue Adhesions studies →

Lead sponsor

University Medical Center Groningen is the lead sponsor of 627 studies on the registry; 175 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • ASA-score III or higher;
  • 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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
30 participants (actual)

Interventions

  • OtherImmediate Dentin Sealing or Delayed Dentin Sealing

    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.

06

What researchers measure

Primary outcomes

  1. Survival

    Survival of the restorations

    Time frame: 3 year

Secondary outcomes

  1. Quality of the restorations

    Criteria according to Hickel and USPHS

    Time frame: 3 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2013 to primary completion in Feb 2018, 51 months.

Of 35 interventional studies with no phase under Tissue Adhesions, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 34. This study's 51 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 18, 2018
First posted
Feb 23, 2018
StartActual
Nov 1, 2013
Primary completionActual
Feb 1, 2018
CompletionActual
Feb 1, 2018
Last update
Feb 27, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03443583
Responsible party
Carline van den Breemer (Principal Investigator, University Medical Center Groningen) — Principal investigator
First posted
Feb 23, 2018
Start date
Nov 1, 2013
Primary completion
Feb 1, 2018
Completion
Feb 1, 2018
Last update
Feb 27, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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