Patients with dental anxiety only develop anxiety and fear about dental treatments. Patients with severe dental anxiety have difficulty cooperating with dental treatments, and can only complete dental treatments through general anesthesia, or even abandon treatments. Dexmedetomidine is a potent, highly selective α2-adrenoceptor agonist, which provides good anxiolytic, sedative and analgesic effects and is commonly used in anesthesiology and intensive care medicine departments, routinely intravenously. In recent years, intranasal administration of dexmedetomidine has also been reported for pediatric dentistry and adult alveolar surgery, showing good sedative and analgesic effects. However, these studies have problems such as single surgical types, small sample size, and few indicators analyzed. Therefore, the evaluation of intranasal administration of dexmedetomidine is still not comprehensive enough. Besides, the anxiolytic effect of dexmedetomidine for dental anxiety has not been reported yet. This project plans to carry out a randomized, double-blinded, placebo-controlled, two-stage clinical trial. We will firstly explore a reasonable dose, and secondly verify it with placebo as the control. We plan to measure the object indicators, including the NTI value, plasma cortisol, interleukin-6, blood pressure and heart rate, and to assess the subjective indicators using scales and questionnaires, thus comprehensively evaluating the effectiveness, safety and feasibility of the anxiolytic effect of intranasal dexmedetomidine for severe dental anxious patients, and preliminary exploring its mechanism additionally. We intend to help severe dental anxious patients completing dental treatments.
Fully understand the purpose and significance of this trial, voluntarily participate in this clinical trial, and voluntarily sign an informed consent form;
Age 18 to 65 years old, regardless of gender;
Diagnosed by a dentist and needs dental treatment;
Can be immediately arranged for dental treatment after being evaluated by the clinician as having no contraindications;
Subjects who are not considered by the researcher to be suitable for nasal drops (such as severe rhinitis, nasal malformations, etc.);
Subjects with a history of severe arrhythmias such as type II or above AV block or a history of cardiac insufficiency;
Subjects with a history of myocardial infarction or unstable angina in the 6 months before the screening period;
Subjects with a history of ischemic stroke or transient ischemic attack (TIA);
Parallel
Dexmedetomidine
Drugintranasal administration of dexmedetomidine
Change of MDAS score
Dental anxious score will be accessed by modified dental anxiety scale (MDAS), and the change of MDAS score will be calculated as the scores right after dental treatments minus the initial score before intervention.
Change of plasma cortisol concentration
The change of plasma cortisol concentration will be calculated as the values right after dental treatments minus the initial values before intervention.
Change of NTI score
The depth of sedation will be accessed by NTI score using Narcotrend, and the change of NTI score will be calculated as the score right after dental treatments minus the initial score before intervention.
Change of OAA/S score
OAA/S score will be accessed by observer's assessment of alertness/sedation scale (OAA/S), which also represent the depth of sedation, and the change of OAA/S score will be calculated as the score right after dental treatments minus the initial score before intervention.
Change of blood pressure (BP)
BP will be continuously accessed using an electrocardiogram monitor throughout the whole clinical process. BP value will be converted into mean arterial pressure (MAP) for comparison using the formula: MAP = (SBP + 2 × DBP)/3. Then the change of BP was presented as ΔMAP, which was calculated as the MAP at the point with the highest SBP minus the initial MAP right before the procedure.
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