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
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2013
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedFirst Submitted
Initial submission to the registry
February 18, 2018
CompletedFirst Posted
Study publicly available on registry
February 23, 2018
CompletedFebruary 27, 2018
February 1, 2018
4.3 years
February 18, 2018
February 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Survival
Survival of the restorations
3 year
Secondary Outcomes (1)
Quality of the restorations
3 year
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- ASA-score III or higher;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 18, 2018
First Posted
February 23, 2018
Study Start
November 1, 2013
Primary Completion
February 1, 2018
Study Completion
February 1, 2018
Last Updated
February 27, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share