Dental Caries Clinical Trial
Official title:
Assessment of Efficacy and Safety of Primary Maxillary Second Molars Anesthesia Using Nasal Spray in Children
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.
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.
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