NCT03443583

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
Last Updated

February 27, 2018

Status Verified

February 1, 2018

Enrollment Period

4.3 years

First QC Date

February 18, 2018

Last Update Submit

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

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Tissue Adhesions

Condition Hierarchy (Ancestors)

CicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

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
Model Details: A split mouth clinical trial comparing ceramic restorations cemented with either IDS or DDS after one year of three years of clinical service.
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