Efficacy and Safety of Primary Teeth Anesthesia Using Nasal Spray in Children
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Nasal Spray of Lidocaine HCL; Infiltration injection of Lidocaine HCL
Intervention type(s): Drug; Drug
Intervention description(s): This spray consists of lidocaine hydrochloride-epinephrine hydrochloride; This is the ordinary method of establishing anesthesia for patients undergoing dental treatment for caries.
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment