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Completed

NCT Number: NCT03140787

Efficacy and Safety of Primary Teeth 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.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

7 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Peadodontics, University of Damascus Dental School

Damascus, DM20AM18, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nasal Spray of Lidocaine HCL

Drug

This spray consists of lidocaine hydrochloride-epinephrine hydrochloride

Infiltration injection of Lidocaine HCL

Drug

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

Primary outcomes

  1. Change in Blood Pressure

    Time frame: (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.

    Systolic and diastolic blood pressure will be measured.

  2. Change in Oxygen Saturation

    Time frame: (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.

    Oxygen saturation will be measured using a specific device.

  3. Change in Respiration Rate

    Time frame: (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.

    Respiration rate will be measured clinically in the conventional manner.

  4. Change in Heart Pulse Rate

    Time frame: (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.

    Heart pulse rate will be measured clinically in the conventional manner.

  5. Change in FLACC scale

    Time frame: (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

    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.

  6. Change in Frankl scale

    Time frame: (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

    This scale will be used to evaluate children's acceptance and will be measured by an external observer at five assessment times.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 4, 2017
Registry last updated
Jul 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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