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

NCT03140787 | Completed DMC

• 1 other identifier: UDDS-Pedo-01-2017
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (6)

• Change in Blood Pressure

  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

  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

  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

  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

  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

  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

Study Arms (2)

Nasal Spray of Lidocaine HCL

EXPERIMENTAL

This group will receive treatment with an application of nasal spray for anesthetization.

Drug: Nasal Spray of Lidocaine HCL

Infiltration injection of Lidocaine HCL

ACTIVE COMPARATOR

Each patient in this group will receive an infiltration injection for anesthetization

Drug: Infiltration injection of Lidocaine HCL

Interventions

Nasal Spray of Lidocaine HCL DRUG

This spray consists of lidocaine hydrochloride-epinephrine hydrochloride

Nasal Spray of Lidocaine HCL

Infiltration injection of Lidocaine HCL DRUG

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

Infiltration injection of Lidocaine HCL

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Peadodontics, University of Damascus Dental School

Damascus, DM20AM18, Syria

Location

Related Publications (6)

• Ciancio SG, Hutcheson MC, Ayoub F, Pantera EA Jr, Pantera CT, Garlapo DA, Sobieraj BD, Almubarak SA. Safety and efficacy of a novel nasal spray for maxillary dental anesthesia. J Dent Res. 2013 Jul;92(7 Suppl):43S-8S. doi: 10.1177/0022034513484334. Epub 2013 May 20.

  PMID: 23690356 BACKGROUND

• Reed KL, Malamed SF, Fonner AM. Local anesthesia part 2: technical considerations. Anesth Prog. 2012 Fall;59(3):127-36; quiz 137. doi: 10.2344/0003-3006-59.3.127.

  PMID: 23050753 BACKGROUND

• Pandey RK, Bahetwar SK, Saksena AK, Chandra G. A comparative evaluation of drops versus atomized administration of intranasal ketamine for the procedural sedation of young uncooperative pediatric dental patients: a prospective crossover trial. J Clin Pediatr Dent. 2011 Fall;36(1):79-84. doi: 10.17796/jcpd.36.1.1774746504g28656.

  PMID: 22900449 BACKGROUND

• Hersh EV, Pinto A, Saraghi M, Saleh N, Pulaski L, Gordon SM, Barnes D, Kaplowitz G, Bloom I, Sabti M, Moore PA, Lee S, Meharry M, He DY, Li Y. Double-masked, randomized, placebo-controlled study to evaluate the efficacy and tolerability of intranasal K305 (3% tetracaine plus 0.05% oxymetazoline) in anesthetizing maxillary teeth. J Am Dent Assoc. 2016 Apr;147(4):278-87. doi: 10.1016/j.adaj.2015.12.008. Epub 2016 Jan 25.

  PMID: 26822100 BACKGROUND

• Kanaa MD, Whitworth JM, Meechan JG. A comparison of the efficacy of 4% articaine with 1:100,000 epinephrine and 2% lidocaine with 1:80,000 epinephrine in achieving pulpal anesthesia in maxillary teeth with irreversible pulpitis. J Endod. 2012 Mar;38(3):279-82. doi: 10.1016/j.joen.2011.11.010. Epub 2011 Dec 22.

  PMID: 22341059 BACKGROUND

• Kanaa MD, Whitworth JM, Meechan JG. A prospective randomized trial of different supplementary local anesthetic techniques after failure of inferior alveolar nerve block in patients with irreversible pulpitis in mandibular teeth. J Endod. 2012 Apr;38(4):421-5. doi: 10.1016/j.joen.2011.12.006. Epub 2012 Feb 2.

  PMID: 22414822 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Mohammad Raslan Alzein, DDS

  MSc student, Department of Paedodontics, University of Damascus Dental School

  PRINCIPAL INVESTIGATOR

• Shadi Azzawi, DDS MSc PhD

  Senior Lecturer in Paedodontics, Department of Paedodontics, University of Damascus Dental School, Damascus, Syria

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: May 4, 2017
• Study Start: May 15, 2016
• Primary Completion: May 15, 2017
• Study Completion: June 15, 2017
• Last Updated: July 27, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)