SECTION 108.14. Pediatric and Special Needs Case Management; Protective Stabilization

(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.

Source Note: The provisions of this §108.14 adopted to be effective June 11, 2014, 39 TexReg 4429; amended to be effective September 3, 2014, 39 TexReg 6856; amended to be effective June 12, 2019, 44 TexReg 2839