| (a) Parent or Guardian. In this section the term "parent
or guardian" refers to one of the following:
(1) the natural or biological father or mother of a
child with full parental legal rights;
(2) a custodial parent who in the case of divorce has
been awarded legal custody of a child;
(3) a person appointed by a court to be the legal guardian
of a minor child; or
(4) a foster parent - a non-custodial parent caring
for a child without parental support or protection who was placed
by local welfare services or a court order.
(b) Applicability. This section applies to the use
of protective stabilization when treating pediatric and special needs
patients.
(1) For purposes of this section a "knee-to-knee
examination" during which the dentist and the patient's parent
or guardian put knees together to create a "dental chair"
is not considered protective stabilization. A knee-to-knee exam does
not use any apparatus or equipment to restrain the patient and does
not involve the use of dental personnel other than the treating dentist.
(2) Although a mouth prop may be used as an immobilization
device, the use of a mouth prop in a compliant child is not considered
protective stabilization for purposes of this section.
(c) Purpose. Infants, children, adolescents, and patients
with special health care needs may require protective stabilization
to prevent injury and protect the health and safety of the patient,
practitioner, and staff, and to safely expedite emergency treatment
for a pre-cooperative child, uncooperative child, or patient with
special health care needs if it is deemed necessary for the long-term
health of the patient. The goals of protective stabilization as a
part of individualized patient behavior guidance are to establish
communication throughout dental care; alleviate fear and anxiety;
deliver quality dental care; build a trusting relationship between
the patient, parent or guardian and the dental professionals; and
promote the patient's positive attitude toward dental care. Protective
stabilization is an advanced behavior guidance technique in dentistry
that can be used for treatment involving pediatric and special needs
patients.
(d) Protective Stabilization.
(1) Protective stabilization is the physical limitation
of a patient's movement by a person, restrictive equipment, materials
or devices for a finite period of time. Two types of protective stabilization
are:
(A) active immobilization, which involves the physical
limitation of movement by another person, such as the parent or guardian,
dentist, or dental auxiliary; and
(B) passive immobilization, which utilizes a restraining
device.
(2) Protective stabilization shall not be used as a
means of discipline, convenience, or retaliation. Protective stabilization
shall not be used for "routine," non-emergent treatment
needs or in order to accomplish full mouth or multiple quadrant dental
rehabilitation. Protective stabilization shall cause no serious consequences,
such as physical or psychological harm, loss of dignity, or violation
of the patient's rights. It is the responsibility of the treating
dentist and the dental team to guard against these aforementioned
outcomes.
(3) Training Requirements. A dentist utilizing protective
stabilization shall have completed advanced training either through:
(A) an accredited post-doctoral program or pediatric
dentistry residency program that provides clinical and didactic education
in advanced behavior management techniques; or
(B) an extensive and focused continuing education course
of no less than 8 hours in advanced behavior management that includes
both didactic and clinical education pertaining to Protective Stabilization.
(4) Practitioner Supervision. The dentist shall not
delegate the use of protective stabilization to the dental staff,
but they may assist the dentist as necessary.
(5) Informed Consent.
(A) Protective stabilization requires written informed
consent from the parent or guardian which should be obtained separately
from consent for other procedures to ensure parent awareness of the
procedure and utilization of protective stabilization. Written informed
consent should be documented in the patient's records.
(B) Informed consent shall include an explanation,
by the treating dentist, of the benefits and risks of protective stabilization,
alternative behavior guidance techniques, and a clear explanation
of the anticipated protective stabilization techniques to be used,
including the possible use of restraining devices, and a statement
that a parent or guardian may revoke informed consent for protective
stabilization at any time.
(C) If possible, the treating dentist should obtain
informed consent for protective stabilization on a day separate from
the treatment requiring protective stabilization.
(D) If the patient's behavior during treatment requires
a change in the protective stabilization, separate informed consent
must be obtained and documented.
(E) When providing dental care for adolescents or adults
with mild intellectual disabilities, patient assent for protective
stabilization should also be considered. Informed consent should take
into account the patient's feelings towards the use of protective
stabilization. A conditional comprehensive explanation of the technique
to be used and the reasons for application should be provided.
(F) A parent or guardian may revoke informed consent
for protective stabilization at any time if they believe the patient
may be experiencing physical or psychological trauma due to immobilization.
(6) Parental or Guardian Presence. The treating dentist
should consider allowing parental or guardian presence in the operatory
or direct visual observation of the patient during use of protective
stabilization unless the health and safety of the patient, parent,
guardian, or dental staff would be at risk. If parents or guardians
are denied access, they must be informed of the reason with documentation
of the explanation in the patient's chart.
(7) Pre-Stabilization Considerations. Prior to utilizing
protective stabilization, the dentist shall consider the following:
(A) alternative behavior management methods;
(B) the dental needs of the patient and the urgency
of the treatment;
(C) the effect on the quality of dental care during
stabilization;
(D) the patient's comprehensive, up-to-date medical
history;
(E) the patient's physical condition, such as neuromuscular
or skeletal disorders; and
(F) the patient's emotional development.
(8) Equipment. The restraining devices used for dental
procedures should include the following characteristics:
(A) ease of use;
(B) appropriately sized for the patient;
(C) soft and contoured to minimize potential injury
to the patient while maintaining blood flow and respiration;
(D) specifically designed for protective stabilization;
and
(E) ability to be disinfected.
(9) Indications. Protective stabilization is indicated
when:
(A) a patient requires immediate diagnosis and/or urgent
limited treatment and cannot cooperate due to emotional and cognitive
developmental levels, lack of maturity, or medical and physical conditions;
(B) urgent care is needed and uncontrolled movements
endanger the patient, staff, or dentist;
(C) treatment is initiated without protective stabilization
and the patient becomes uncooperative, causing uncontrolled movements
that endanger the patient, staff, or dentist, and protective stabilization
will enable the dentist to protect the patient's safety and help to
expedite completion of treatment;
(D) a sedated patient requires limited stabilization
to help reduce untoward movements during treatment;
(E) an uncooperative patient requires limited treatment
and sedation or general anesthesia may not be an option because the
patient does not meet sedation criteria, there is a long operating
room wait time, financial considerations, and/or parental or guardian
preferences after other options have been discussed; or
(F) a patient with special health care needs exhibits
uncontrolled movements that would be harmful or significantly interfere
with the quality of care.
(10) Contraindications. Protective stabilization is
contraindicated for:
(A) cooperative, non-sedated patients;
(B) patients who cannot be immobilized safely due to
associated medical, psychological, or physical conditions;
(C) patients with a history of physical or psychological
trauma due to restraint;
(D) patients with non-emergent treatment needs in order
to accomplish full mouth or multiple quadrant dental rehabilitation;
or
(E) the dentist's convenience.
(11) Documentation. In addition to the record requirements
in §108.8 of this title (relating to Records of the Dentist),
the patient records shall include:
(A) indication for stabilization;
(B) type of stabilization;
(C) informed consent for protective stabilization;
(D) reason for parental exclusion during protective
stabilization (when applicable);
(E) the duration of application of stabilization;
(F) behavior evaluation/rating monitoring during stabilization;
(G) any adverse outcomes, such as bruising or skin
markings; and
(H) management implications and plans for future appointments.
(12) Patients with Special Health Care Needs.
(A) Children and adolescents with special health care
needs will at times require protective stabilization to facilitate
completion of necessary dental treatment. Aggressive, uncontrolled,
and impulsive behaviors along with involuntary movements may cause
harm to both the patient and dental personnel. Use of protective stabilization
reduces potential risks and provides safer management of patients
with special health care needs. When considering protective stabilization
during dental treatment for special health care needs patients, the
dentist in collaboration with the parent or guardian must consider
the importance of treatment and the safety consideration of the restraint.
(B) The dentist should be cautious when utilizing protective
stabilization on children and adolescents receiving multiple medications.
The propensity of adverse central nervous system or cardiac events
occurring may increase when protective stabilization is instituted
on patients receiving psychotropic or other medications.
(C) The dentist should consider utilizing alternative
behavioral approaches to reduce movement and resistance as well as
increasing cooperation when proving medically necessary dental care
for patients with special health care needs prior to implementing
protective stabilization, such as:
(i) distraction via counting, positional modeling,
and repetitive tasks and visits;
(ii) shaping;
(iii) modeling;
(iv) sensory integration;
(v) desensitization;
(vi) reinforcement; or
(vii) non-pharmacological behavior guidance approaches
by skill training in acceptable behaviors in the dental operatory.
(e) Deferred Treatment. Treatment deferral or discontinuance
shall be considered in cases when treatment is in progress and the
patient's behavior becomes hysterical or uncontrollable. In such cases,
the dentist shall halt the procedure, discuss the situation with the
parent or guardian, and either select another approach for treatment
or defer treatment based upon the dental needs of the patient. Upon
the decision to defer treatment, the dentist shall immediately complete
the necessary steps to bring the procedure to a safe conclusion before
ending the appointment. A recall schedule shall be recommended after
evaluation of the patient's risk, oral health needs, and behavior
abilities.
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