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Intranasal Dexmedetomidine for Severe Dental Anxiety: a Randomized Trial

NCT05500261 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-11-02

No results posted yet for this study

Summary

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.

Conditions

  • Dental Anxiety

Interventions

DRUG

Dexmedetomidine

intranasal administration of dexmedetomidine

Sponsors & Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Zeman Qin, Master · Department of General Dentistry, Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2023-07-23
Completion
2023-07-23

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05500261 on ClinicalTrials.gov