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

Damascus University

Status

Completed

Conditions

Dental Caries

Treatments

Drug: Nasal Spray of Lidocaine HCL

Drug: Infiltration injection of Lidocaine HCL

Study type

Interventional

Funder types

Other

Identifiers

NCT03140787

UDDS-Pedo-01-2017

Details and patient eligibility

About

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.

Full description

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.

Enrollment

68 patients

Sex

All

Ages

7 to 10 years old

Volunteers

No Healthy Volunteers

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.