An Evaluation of Protective Effects of OpalSeal™ Against Early Dental Decay in Orthodontic Patients. A Pilot Study
Phase: NA
Conditions: Cavities of Teeth
Sponsor: Virginia Commonwealth University

 
 
Title: An Evaluation of Protective Effects of OpalSeal™ Against Early Dental Decay in Orthodontic Patients 
 
NCT #: NCT03722264 
 
Document approval date: October 25, 2017 
 
Document Type: Protocol 
 
 
 

 
Group
Types
Waivers
Roles
Roles
-
Other
Consent
Coercion Decision
Re-
Consent
View Participant
between
the ages
of 10 to
less than
18
Assent by Child
or Decisionally
Impaired Adult
Written/Signed
Consent by
Parent/Guardian
(for child) or
Legally
Authorized
Representative
(for adult)
Short Form
Consent (limited
applicability)
Waiver of
Parental
Permission or
Legally
Authorized
Representative
Consent
Waiver of
Assent by
Child or
Decisionally
Impaired Adult
Waiver of
Some or All
Elements of
Consent
Principal
Investigator
Co/Sub-
Investigator
Trainee/Student
 
Assent from the
child and consent
from the
parent/guardian will
be obtained during
the consult
appointment in a
private room at the
VCU Orthodontic
clinic. Additionally,
we will ensure the
participants'
continued
willingness to
participate by asking
at each visit if they
wish to continue with
the study. We will
stress that there will
be no penalty for
withdrawing from the
study.
Subjects
will be told
that
participation
is voluntary,
and if they
choose not
to
participate,
treatment
will not be
affected.
Patients will be
given up to their
bonding
appointment
(when they get
there braces on)
to make the
decision.
Typically, this
gives
patients/parents
about 2 weeks.
If any of our
participants
become
adults
during the
study, they
will be re-
consented
as adults
during their
next in-
office
appointment
View Adult
participant
Written/Signed
Consent by
Participant
Assent by Child
or Decisionally
Impaired Adult
Short Form
Consent (limited
applicability)
Waiver of
Parental
Permission or
Legally
Authorized
Representative
Consent
Waiver of
Assent by
Child or
Decisionally
Impaired Adult
Waiver of
Some or All
Elements of
Consent
Principal
Investigator
Co/Sub-
Investigator
Trainee/Student
 
During their consult
appointment in a
private room at the
VCU Orthodontic
clinic. Additionally,
we will ensure the
participants'
continued
willingness to
participate by asking
at each visit if they
wish to continue with
the study. We will
stress that there will
be no penalty for
withdrawing from the
study.
Subjects
will be told
that
participation
is voluntary,
and if they
choose not
to
participate,
treatment
will not be
affected.
Patients will be
given up to their
bonding
appointment
(when they get
there braces on)
to make the
decision.Typically,
this gives patients
about 2 weeks.
If adult
participants
are no
longer
decisionally
impaired,
they will be
approached
with new
consent
form and
new
signature
obtained
during their
next in-
office
appointment
2. Upload any consent / assent documents
ID: HM20011025
View: SF - Waiver of Some or All Elements of Consent
  
Waiver of Some or All Elements of Consent
Consent groups that require a waiver of some or all elements of consent
Group
Types Waivers Roles
Roles
-
Other
Consent
Coercion Decision
Status Change
Participant
between
the ages
of 10 to
less than
18
 
 
 
 
Assent from the child and consent from the
parent/guardian will be obtained during the
consult appointment in a private room at
the VCU Orthodontic clinic. Additionally, we
will ensure the participants' continued
willingness to participate by asking at each
visit if they wish to continue with the study.
We will stress that there will be no penalty
for withdrawing from the study.
Subjects will
be told that
participation
is voluntary,
and if they
choose not
to
participate,
treatment will
not be
affected.
Patients will be
given up to their
bonding
appointment
(when they get
there braces on)
to make the
decision. Typically,
this gives
patients/parents
about 2 weeks.
If any of our
participants
become adults
during the study,
they will be re-
consented as
adults during their
next in-office
appointment
Adult
participant
 
 
 
 
During their consult appointment in a
private room at the VCU Orthodontic clinic.
Additionally, we will ensure the participants'
continued willingness to participate by
asking at each visit if they wish to continue
with the study. We will stress that there will
be no penalty for withdrawing from the
study.
Subjects will
be told that
participation
is voluntary,
and if they
choose not
to
participate,
treatment will
not be
affected.
Patients will be
given up to their
bonding
appointment
(when they get
there braces on)
to make the
decision.Typically,
this gives patients
about 2 weeks.
If adult participants
are no longer
decisionally
impaired, they will
be approached with
new consent form
and new signature
obtained during
their next in-office
appointment
The basic elements of informed consent are as follows
1. All of the following:
a statement that the study involves research
an explanation of the purposes of the research
an explanation of the expected duration of the participant's involvement
a description of the procedures to be followed
identification of any procedures which are experimental
2. A description of any reasonably foreseeable risks or discomforts to the participant
3. A description of any benefits to the participant or to others which may reasonably be expected from the research
4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant
5. A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained
6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any
medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained
7. An explanation of whom to contact for answers to pertinent questions about the research and research participants' rights, and whom to
contact in the event of a research-related injury to the participant
8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is
otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the
participant is otherwise entitled