Determination of the effect of diphenhydramine mouthwash on pain during inferior alveolar nerve block injection.
Design
A clinical trial with a control group, featuring parallel groups randomized using random number generation in Excel for 40 patients.
Settings and conduct
In this study, eligible patients from Alborz Dental School clinic will be randomly divided into two groups: one using diphenhydramine mouthwash (15 mL) and the other using normal saline. Pain levels (measured via VAS) will be recorded 5 minutes after anesthesia. No blinding will be used.
Participants/Inclusion and exclusion criteria
inclusion criteria:
1. Injection of IANB (Inferior Alveolar Nerve Block) is required on both sides of the lower jaw.
2. The patient has no contraindications to the injection of lidocaine epinephrine.
exclusion criteria:
1. Patients with a history of systemic diseases will be excluded from the study.
2. Lack of patient consent.
Intervention groups
Intervention: Participants in this group will use a mouthwash containing 0.2% diphenhydramine hydrochloride (Diphenhydramine HCl) (Al-Hawi Pharmaceutical Company) prior to the inferior alveolar nerve block injection. Each person will be asked to swish 15 ml of the solution in their mouth for 30 seconds and then spit it out. This intervention will be performed only once, 5 minutes before the injection.
Control: Participants in the control group will use normal saline solution (NaCl 0.9%) (Shahid Ghazi Factory). 15 ml of the solution is swished around in the mouth for 30 seconds and then spit out, and is consumed only once, 5 minutes before the block injection.
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250412065293N1
Registration date:2025-05-05, 1404/02/15
Registration timing:prospective
Last update:2025-05-05, 1404/02/15
Update count:0
Registration date
2025-05-05, 1404/02/15
Registrant information
Name
marzie ghare sheykhlou
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3277 5504
Email address
yasaman.sh@gmail.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2025-05-22, 1404/03/01
Expected recruitment end date
2025-09-22, 1404/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Diphenhydramine Mouthwash on pain during inferior alveolar nerve block injection: a clinical trial study
Public title
The effect of diphenhydramine mouthwash on pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Injection of Inferior Alveolar Nerve Block is required on both sides of the lower jaw
The patient has no contraindications to the injection of lidocaine epinephrine.
Exclusion criteria:
Patients with a history of systemic diseases
Lack of consent to participate in the study.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random allocation of participants to the intervention and control groups will be performed using simple randomization and the RAND function in Microsoft Excel. First, a list of 40 participants will be prepared, and a random number between 0 and 1 will be generated next to each individual using the =RAND() function. The table will then be sorted in ascending order based on these random numbers. The first 20 participants will be assigned to the intervention group (diphenhydramine mouthwash), and the next 20 participants will be assigned to the control group (placebo).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Alborz University of Medical Sciences
Street address
Vice-Chancellery for Research and Technology, Safarian Alley, 45-Metri Golshahr, Karaj, Iran.
City
Karaj
Province
Alborz
Postal code
3198764653
Approval date
2025-02-22, 1403/12/04
Ethics committee reference number
IR.ABZUMS.REC.1403.344
Health conditions studied
1
Description of health condition studied
Inferior Alveolar Nerve Block
ICD-10 code
K08.8
ICD-10 code description
Other specified disorders of teeth and supporting structures
Primary outcomes
1
Description
pain
Timepoint
Immediately and 5 minutes after anesthetic injection.
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Participants in this group will use a mouthwash containing diphenhydramine hydrochloride at a concentration of 0.2% before the inferior alveolar nerve block injection. (From Al-Hawi Pharmaceutical Company) Each person will be asked to swish 15 ml of the solution in their mouth for 30 seconds and then spit it out. Swallowing the solution is not allowed. This intervention will be performed only once, 5 minutes before the injection.
Category
Treatment - Other
2
Description
Control group: Participants in the control group will use a placebo mouthwash (shahid ghazi company). This solution contains 0.9% normal saline and does not contain any active pharmaceutical ingredient. 15 ml of the placebo solution is swished around the mouth for 30 seconds and then spit out. It is not allowed to swallow and is used only once, 5 minutes before the block injection.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alborz School of Dentistry
Full name of responsible person
Arezu Agha Koochakzadeh
Street address
School of Dentistry, Shahid Ketooei Zadeh Street, 45-Metri Golshahr, Karaj, Iran
City
karaj
Province
Alborz
Postal code
3198684868
Phone
+98 26 3353 1614
Email
dentalclinic@abzums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Raziyeh Lotfi
Street address
Vice-Chancellery for Research, Alborz University of Medical Sciences, Safarian Alley, 45-Metri Golshahr, Karaj, Iran.
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3774
Email
Research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?