Randomized split-mouth clinical trial comparing pain, anxiety and disruptive behavior during inferior alveolar nerve block using traditional syringe and digital.
to determine the relationship between the levels of pain, anxiety, and disruptive behavior in children during inferior alveolar nerve block injection using two methods: traditional and digital.
Design
A randomized, double-blind, controlled clinical trial with a cross-over design involving 15 patients.
Settings and conduct
Children aged 5–8 years from Qazvin School of Dentistry (pediatric department) will be randomly assigned to two groups. Each group will receive both traditional and digital injections one week apart, in reverse order.
Participants/Inclusion and exclusion criteria
Inclusion criteria: children aged 5 to 8 years, provided that their developmental stage is consistent with their chronological age; children classified as American Society of Anesthesiologists (ASA) physical status I; children requiring bilateral mandibular nerve blocks; and children with no prior history of receiving dental local anesthesia before the study.
Exclusion criteria: patients with a history of hypersensitivity to local anesthetics; patients with any mental or physical condition that might interfere with the treatment procedure.
Intervention groups
Group I: Traditional method in first session → CCLAD (DentaPen) in second session.
Group II: CCLAD in first session → Traditional method in second session.
Procedure (per patient per session):
Tell-Show-Do technique.
Dry injection site with cotton swab for 60 seconds.
Apply procaine gel for 2 minutes.
Use 27-gauge, 25 mm needle.
Inject 1.5–1.8 mL of 2% lidocaine with 1:80,000 epinephrine after contacting bone.
Measurements (at three time points): Pulse rate, blood pressure, FLACC, Venham anxiety scale (VPTm), and Wong–Baker Faces Pain Rating Scale (WBF).
Randomized split-mouth clinical trial comparing pain, anxiety and disruptive behavior during inferior alveolar nerve block using traditional syringe and digital.
Public title
clinical trial comparing pain, anxiety and disruptive behavior during inferior alveolar nerve block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
children aged 5 to 8 years, provided that their developmental stage is consistent with their chronological age
children classified as American Society of Anesthesiologists (ASA) physical status I
children requiring bilateral mandibular nerve blocks
children with no prior history of receiving dental local anesthesia before the study
Exclusion criteria:
patients with a history of hypersensitivity to local anesthetics
patients with any mental or physical condition that might interfere with the treatment procedure.
Age
From 5 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
Each patient will receive different interventions on each side of the mouth.
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using sealed, opaque envelopes containing an equal number of intervention (digital method) and control (traditional method) allocations will be employed. The envelopes will be provided to a ward nurse who is not involved in any subsequent part of the study. Each time, the nurse will draw one envelope to determine whether the patient will receive the intervention or control.
Blinding (investigator's opinion)
Double blinded
Blinding description
he injection technique for the block will be performed in such a way that the child (participant) cannot see the type of syringe used. Furthermore, the group allocation results for each subject will be provided to the statistical analyst in the form of numerical codes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Intervention group: Here is the scientific English translation of the "Intervention Group" text you provided, without additional explanations:**Intervention group:** Informed consent will first be obtained from the patient. A complete medical and dental history will be taken in writing from the parents. Subsequently, a full patient examination, including clinical and radiographic evaluation, will be performed. The clinical examination will be conducted first, and a diagnosis of dental caries in tooth D or E will be made. To confirm the diagnosis and the need for pulp therapy, a periapical radiograph will be taken. The treatment plan—either pulpotomy or pulpectomy—and the need for bilateral mandibular nerve block will be established. It should be noted that in each child, the tooth type (D or E) and the treatment plan (pulpotomy or pulpectomy) will be exactly the same on both sides of the mouth.1) The tell-show-do technique will first be performed for the patient.2) A cotton roll will be placed on the anesthesia injection site for 60 seconds to completely dry the area.3) Proccaine gel will be applied to the anesthesia site for 2 minutes.4) An appropriate needle (27-gauge, 25 mm length) will then be selected.5) The needle will be inserted into the tissue using the Dentapen device. After passing through the mucosa and contacting the bone, 1.5 to 1.8 mL of local anesthetic solution—lidocaine 2% with epinephrine 1:80,000—will be injected.
Category
Treatment - Other
2
Description
Control group: Here is the scientific English translation of your text, as requested without explanations:"Informed consent will first be obtained from the patient. A complete medical and dental history will be taken in writing from the parents. Subsequently, a full patient examination, including clinical and radiographic evaluation, will be performed. The clinical examination will be conducted first, and a diagnosis of dental caries in tooth D or E will be made. To confirm the diagnosis and the need for pulp therapy, a periapical radiograph will be taken. The treatment plan—either pulpotomy or pulpectomy—and the need for bilateral mandibular nerve block will be established. It should be noted that in each child, the tooth type (D or E) and the treatment plan (pulpotomy or pulpectomy) will be exactly the same on both sides of the mouth.1) The tell-show-do technique will first be performed for the patient.2) A cotton roll will be placed on the anesthesia injection site for 60 seconds to completely dry the area.3) Proccaine gel will be applied to the anesthesia site for 2 minutes.4) An appropriate needle (27-gauge, 25 mm length) will then be selected.5) The needle will be inserted into the tissue using a traditional syringe. After passing through the mucosa and contacting the bone, 1.5 to 1.8 mL of local anesthetic solution—lidocaine 2% with epinephrine 1:80,000—will be injected."
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvin university of medical sciences
Full name of responsible person
Razie Sadat Hosseininavaz
Street address
Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3335 3062
Email
rshn1016@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mahdi Mirhashemi
Street address
Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
13911/34156
Phone
+98 28 7777 3333
Email
rshn1016@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Qazvin university of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Razie Sadat Hosseininavaz
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
13911/34156
Phone
+98 28 7777 3333
Email
rshn1016@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Razie sadat Hosseininavaz
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
3471976160
Phone
+98 28 3335 3062
Email
rshn1016@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Razie sadat Hosseininvaz
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
3471976160
Phone
+98 28 3335 3062
Email
rshn1016@gamil.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available