Efficacy and Safety of Primary Teeth Anesthesia Using Nasal Spray in Children

Study Overview
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Brief Summary
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68 healthy children from the Department of Pediatric Dentistry at Damascus University who require treatment for their primary maxillary second molars will be randomly assigned into one of two groups: experimental or control groups. In the experimental group, a lidocaine hydrochloride-epinephrine hydrochloride nasal spray will be applied to anesthetize upper second molar before the commencement of treatment. To assess the efficacy of this kind of anesthesia, a specific scale will be used by an external observer after capturing some video files of the performed treatment. To assess the safety of this procedure, vital signs will be recorded before and after treatment. Acceptance of the nasal spray will be recorded based on the child's behavior before and after treatment using Frankl scale. If anesthesia was not sufficient to proceed with the procedure, a rescue anesthesia would be used. Rescue anesthesia consists of an infiltration injection of lidocain hydrochloride 2% with epinephrine hydrochloride (1:100,000). In the control group, an intra-oral lidocaine-epinephrine injection will be applied due to treatment. Safety, efficacy and acceptance will be assessed in the same manner to what is performed in the experimental group.

Detailed Description
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The most common method for anesthetizing maxillary teeth is infiltration injection of an anesthetic agent. This approach carries several disadvantages. First is the child's fear of pain. Infection is also a risk for providers, through exposure to blood-borne pathogens via needle stick. Fear of a painful dental injection and subsequent avoidance behavior are significant barriers to regular visits to the dentist. Importantly, patients' fear of injections can delay needed dental care. Surveys indicate that 30-40 million people in the US avoid going to the dentist because of fear of pain and anesthetic injections. Therefore an anesthetic procedure that would avoid the discomfort of a local anesthetic injection thus obviating fear and anxiety about receiving a shot, would greatly benefit dental patients. Further, for procedures involving more than one maxillary tooth on the same side, a trans-nasally applied anesthetic agent that could anesthetize multiple maxillary teeth at once instead of use of repeated infiltration injections would be a major convenience for patients and dentists.

Official Title
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Assessment of Efficacy and Safety of Primary Maxillary Second Molars Anesthesia Using Nasal Spray in Children

Conditions
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Dental Caries

Intervention / Treatment
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* Drug: Nasal Spray of Lidocaine HCL
* Drug: Infiltration injection of Lidocaine HCL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy children between 7-10 years. With a need for pulpotomy or a restorative dental procedure requiring local anesthesia for a single vital primary maxillary second molar with no evidence of pulpal necrosis. Normal lip, nose, eyelid, and cheek sensation. No history of allergy for lidocaine-hydrochloride or epinephrine-hydrochloride. Exclusion Criteria: Frequent bleeding form the nose (≥ 5 per month) Inadequately controlled active thyroid disease of any type. Having received dental care requiring a local anesthetic within the 24 hours preceding study entry. History of allergy to or intolerance of lidocaine or epinephrine.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nasal Spray of Lidocaine HCL<br>This group will receive treatment with an application of nasal spray for anesthetization. | Drug: Nasal Spray of Lidocaine HCL<br>* This spray consists of lidocaine hydrochloride-epinephrine hydrochloride<br>|
| Active Comparator: Infiltration injection of Lidocaine HCL<br>Each patient in this group will receive an infiltration injection for anesthetization | Drug: Infiltration injection of Lidocaine HCL<br>* This is the ordinary method of establishing anesthesia for patients undergoing dental treatment for caries.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Blood Pressure | Systolic and diastolic blood pressure will be measured. | (1) five minutes before drug administration, (2) after 10 minutes of anesthesia, and (3) at the completion of the dental treatment, an average of 40 minutes. | 
| Change in Oxygen Saturation | Oxygen saturation will be measured using a specific device. | (1) five minutes before drug administration, (2) after 10 minutes of anesthesia, and (3) at the completion of the dental treatment, an average of 40 minutes. | 
| Change in Respiration Rate | Respiration rate will be measured clinically in the conventional manner. | (1) five minutes before drug administration, (2) after 10 minutes of anesthesia, and (3) at the completion of the dental treatment, an average of 40 minutes. | 
| Change in Heart Pulse Rate | Heart pulse rate will be measured clinically in the conventional manner. | (1) five minutes before drug administration, (2) after 10 minutes of anesthesia, and (3) at the completion of the dental treatment, an average of 40 minutes. | 
| Change in FLACC scale | This scale will be used to evaluate efficacy. It will be studied by an external observer at 5 stages; first stage: during administration of the drug, second stage: while probing the gingiva around the tooth buccally, palatally, third stage: when penetration of the dentino-enamel junction occurs, fourth stage: when exposure of the dental pulp occurs, fifth stage: during the removal of the coronal pulp. | (1) within the first minute of drug administration, (2) when probing the gingiva at approx. Minute 5, (3) when entering the dentin at approx. Minute 10, (4) when exposing the pulp at approx. Minute 15, (5) during the removal of the pulp at Minute 20 | 
| Change in Frankl scale | This scale will be used to evaluate children's acceptance and will be measured by an external observer at five assessment times. | (1) within the first minute of drug administration, (2) when probing the gingiva at approx. Minute 5, (3) when entering the dentin at approx. Minute 10, (4) when exposing the pulp at approx. Minute 15, (5) during the removal of the pulp at Minute 20 |