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

NCT03140787 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2017-07-27

No results posted yet for this study

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.

Conditions

  • Dental Caries

Interventions

DRUG

Nasal Spray of Lidocaine HCL

This spray consists of lidocaine hydrochloride-epinephrine hydrochloride

DRUG

Infiltration injection of Lidocaine HCL

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

Sponsors & Collaborators

  • Damascus University

    lead OTHER

Principal Investigators

  • Mohammad Raslan Alzein, DDS · MSc student, Department of Paedodontics, University of Damascus Dental School

  • Shadi Azzawi, DDS MSc PhD · Senior Lecturer in Paedodontics, Department of Paedodontics, University of Damascus Dental School, Damascus, Syria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-15
Primary Completion
2017-05-15
Completion
2017-06-15

Countries

  • Syria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03140787 on ClinicalTrials.gov