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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-15

Study Completion Date

2017-06-15

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.

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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.

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nasal Spray of Lidocaine HCL

This group will receive treatment with an application of nasal spray for anesthetization.

Group Type EXPERIMENTAL

Nasal Spray of Lidocaine HCL

Intervention Type DRUG

This spray consists of lidocaine hydrochloride-epinephrine hydrochloride

Infiltration injection of Lidocaine HCL

Each patient in this group will receive an infiltration injection for anesthetization

Group Type ACTIVE_COMPARATOR

Infiltration injection of Lidocaine HCL

Intervention Type DRUG

This is the ordinary method of establishing anesthesia for patients undergoing dental treatment for caries.

Interventions

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Nasal Spray of Lidocaine HCL

This spray consists of lidocaine hydrochloride-epinephrine hydrochloride

Intervention Type DRUG

Infiltration injection of Lidocaine HCL

This is the ordinary method of establishing anesthesia for patients undergoing dental treatment for caries.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy children between 7-10 years.
2. 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.
3. Normal lip, nose, eyelid, and cheek sensation.
4. No history of allergy for lidocaine-hydrochloride or epinephrine-hydrochloride.

Exclusion Criteria

1. Frequent bleeding form the nose (≥ 5 per month)
2. Inadequately controlled active thyroid disease of any type.
3. Having received dental care requiring a local anesthetic within the 24 hours preceding study entry.
4. History of allergy to or intolerance of lidocaine or epinephrine.

Minimum Eligible Age

7 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No