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

July 26, 2017 updated by: Damascus University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Syrian Arab Republic
      • Damascus, Syrian Arab Republic, DM20AM18
        • Department of Peadodontics, University of Damascus Dental School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 10 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy children between 7-10 years.
  2. 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.
  3. Normal lip, nose, eyelid, and cheek sensation.
  4. No history of allergy for lidocaine-hydrochloride or epinephrine-hydrochloride.

Exclusion Criteria:

  1. Frequent bleeding form the nose (≥ 5 per month)
  2. Inadequately controlled active thyroid disease of any type.
  3. Having received dental care requiring a local anesthetic within the 24 hours preceding study entry.
  4. History of allergy to or intolerance of lidocaine or epinephrine.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Nasal Spray of Lidocaine HCL
This group will receive treatment with an application of nasal spray for anesthetization.
Drug: Nasal Spray of Lidocaine HCL
This spray consists of lidocaine hydrochloride-epinephrine hydrochloride
ACTIVE_COMPARATOR: Infiltration injection of Lidocaine HCL
Each patient in this group will receive an infiltration injection for anesthetization
Drug: Infiltration injection of Lidocaine HCL
This is the ordinary method of establishing anesthesia for patients undergoing dental treatment for caries.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
(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.
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.
(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.
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.
(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.
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.
(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.
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.
(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
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.
(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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Investigators

  • Principal Investigator: Mohammad Raslan Alzein, DDS, MSc student, Department of Paedodontics, University of Damascus Dental School
  • Study Director: Shadi Azzawi, DDS MSc PhD, Senior Lecturer in Paedodontics, Department of Paedodontics, University of Damascus Dental School, Damascus, Syria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 15, 2016

Primary Completion (ACTUAL)

May 15, 2017

Study Completion (ACTUAL)

June 15, 2017

Study Registration Dates

First Submitted

April 14, 2017

First Submitted That Met QC Criteria

May 2, 2017

First Posted (ACTUAL)

May 4, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 27, 2017

Last Update Submitted That Met QC Criteria

July 26, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-Pedo-01-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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