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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03140787
• Date of registration: 14/04/2017
• Prospective Registration: No
• Primary sponsor: Damascus University
• Public title: Efficacy and Safety of Primary Teeth Anesthesia Using Nasal Spray in Children
• Scientific title: Assessment of Efficacy and Safety of Primary Maxillary Second Molars Anesthesia Using Nasal Spray in Children
• Date of first enrolment: May 15, 2016
• Target sample size: 68
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03140787
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Syrian Arab Republic

Contacts

• Name: Mohammad Raslan Alzein, DDS
• Affiliation: MSc student, Department of Paedodontics, University of Damascus Dental School

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

Key inclusion & exclusion criteria

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.



Age minimum: 7 Years
Age maximum: 10 Years
Gender: All

Health Condition(s) or Problem(s) studied

Dental Caries

Intervention(s)

Drug: Infiltration injection of Lidocaine HCL

Drug: Nasal Spray of Lidocaine HCL

Primary Outcome(s)

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.]

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]

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]

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.]

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.]

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.]

Secondary ID(s)

UDDS-Pedo-01-2017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors