Clinical trial NCT05338983: Effect of Different Approaches of Delivering Local Dental Anesthesia on Pain Perception in Children.
Official title: Effect of Different Approaches of Delivering Local Dental Anesthesia on Pain Perception in Children. A Double Blinded Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Local Anesthetics
Epinephrine
Vibration
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Children will be divided into 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).
Primary purpose: SUPPORTIVE_CARE

Brief 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).

Eligibility criteria: Inclusion Criteria:

1. Children requiring maxillary infiltration LA for dental treatment.
2. Cooperative children (positive or definitely positive on Frankel's scale).
3. Children are in apparently good health and not taking any medications that will alter their pain perception.
4. Children have no history of allergy to Mepivacaine

Exclusion Criteria:

1. The person responsible does not authorize the participation of the child as a research volunteer.
2. Be using pain modulating drugs.
3. Patients with a history of hypersensitivity to local anesthetics.
4. Patients with a history of systemic diseases.

Primary outcomes:
measure: Pain Behavoir
timeFrame: During the anesthetic procedure
measure: Self-perception of pain
timeFrame: Immediately after anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Dentistry
Study officials:
affiliation: Dentist at Ministry of Health B.D.S (2013), Diploma (2016)
name: Sahar H Zidan
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Pediatric Dentistry Faculty of Dentistry, Mansoura University
name: Nadia M Farrag
role: STUDY_DIRECTOR
affiliation: Lecturer of Pediatric Dentistry Faculty of Dentistry Mansoura University
name: Ahmed H Wahba
role: STUDY_DIRECTOR
References:
citation: Leff DR, Nortley M, Dang V, Bhutiani RP. The effect of local cooling on pain perception during infiltration of local anaesthetic agents, a prospective randomised controlled trial. Anaesthesia. 2007 Jul;62(7):677-82. doi: 10.1111/j.1365-2044.2007.05056.x.
citation: Roeber B, Wallace DP, Rothe V, Salama F, Allen KD. Evaluation of the effects of the VibraJect attachment on pain in children receiving local anesthesia. Pediatr Dent. 2011 Jan-Feb;33(1):46-50.
citation: Ram D, Hermida LB, Peretz B. A comparison of warmed and room-temperature anesthetic for local anesthesia in children. Pediatr Dent. 2002 Jul-Aug;24(4):333-6.
citation: Aravena PC, Barrientos C, Troncoso C, Coronado C, Sotelo-Hitschfeld P. Effect of warming anesthetic on pain perception during dental injection: a split-mouth randomized clinical trial. Local Reg Anesth. 2018 Feb 22;11:9-13. doi: 10.2147/LRA.S147288. eCollection 2018.