NCT05338983

Effect of Different Approaches of Delivering Local Dental Anesthesia on Pain Perception in Children.

Effect of Different Approaches of Delivering Local Dental Anesthesia on Pain Perception in Children. A Double Blinded Randomized Controlled Clinical Trial.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Accepted

Summary

The aim of the study is to compare the efficacy of three different approaches of local anesthesia (LA) administration (Warm\[37°C\] LA, Buffered LA, and BUZZY device) on pain perception to young children ( 6-12 years old) using sound -eye -motor and Wong-Baker FPR scales.

Detailed description

Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage.In pediatric dentistry, the injection of local anesthesia is the most common cause of fear and expected to be painful.So, an effective pain control significantly contributes to an optimal dental treatment in pediatric dentistry.Proper pain prevention may enhance the child's cooperation by building dentist-child trust and reducing fear and/or anxiety during the current or future visit(s). The purpose of this study is to compare the efficacy of three different approaches of LA administration(Warm\[37°C\] LA, Buffered LA, and BUZZY device) on pain perception to young children ( 6-12 years old) using sound -eye -motor and Wong-Baker FPR scales. This study will be conducted on 80 children aged between 6-12 years from pediatric dental clinic, Faculty of Dentistry, Mansoura University. Children will be divided to 4 equal groups, 20 children each. Three experimental groups, and a (control group) . The 4 groups will be randomly allocated for each technique using block technique of simple random sampling .Randomized block designs are constructed to reduce noise or variance in the data. Every block will include the equal number of the four groups (three experimental and one control).

Conditions

• Pain
• Local Anesthetics
• Epinephrine
• Vibration

Interventions

Type	Name	Description
DRUG	Topical anesthetic	20% Benzocaine gel will be applied on the area of infiltration
DEVICE	Avent baby bottle warmer	Warming device
DRUG	Sodium bicarbonate	0.1ml of 8.4% of sodium bicarbonate will be removed from the 50ml vial by one ml insulin syringe , directly injected into the local anesthetic cartridge and will be shacked 5 times to mix the solution.
DEVICE	Buzzy device	Bee-shaped apparatus consisting of two parts: the main vibrating body of a bee and detachable ice wings. External application of Buzzy device during administration of dental anesthetic.
DRUG	Mepivacaine Hydrochloride	Mepivacaine HCL 2% with Epinephrine 1:100,000 Local Anesthetic. Local Dental anesthetic infiltration

Timeline

• Start date: 2022-05-01
• Primary completion: 2023-05-01
• Completion: 2023-06-01
• First posted: 2022-04-21
• Last updated: 2022-04-29

Locations

1 site across 1 country: Egypt