Current through Reg. 50, No. 13; March 28, 2025
(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. MP> (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:
(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;
(iv) sensory integration;
(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.