Effect of Supplementary Anesthesia of Mental Incisive Nerve Block, and Buccal Infiltration on Anesthetic Success of Inferior Alveolar Nerve Block, using 4% Articaine in Mandibular First Molars with Symptomatic Irreversible Pulpitis: A Double Blind Randomized Clinical Trial
Determination of the effect of Supplementary Incisive nerve block and buccal infiltration on the success of inferior alveolar nerve block, using 4% articaine on anesthesia of mandibular first molars with symptomatic irreversible pulpitis
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 75 patients. A random number table was used for randomization.
Settings and conduct
A total of 75 patients with inclusion criteria who referred to Alborz Dental Clinic in Urmia.
Participants/Inclusion and exclusion criteria
Criteria for inclusion in this study include healthy adults aged 18 to 60 years, first molars with irreversible pulpitis on one side of the mandible, and normal periapical radiographs. Exclusions of this study include systemic disease, patients with severe stress, patients with toothache at the time of study, unstable heart disease, sensitivity to 4% articaine anesthetic with epinephrine or latex, facial or oral paraesthesia, use of any analgesic In the 12 hours before treatment, the use of psychotropic and neurological drugs, asymptomatic irreversible pulpitis, the presence of periapical radiolucency, pregnancy, lactation, irreparable teeth and the presence of veneers on the teeth.
Intervention groups
1. The group receiving the incisor nerve block supplemental anesthesia
2. The group receiving the infiltration supplemental anesthesia
3. The group that does not receive any supplemental anesthesia
Main outcome variables
Intensity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180513039638N2
Registration date:2021-05-11, 1400/02/21
Registration timing:prospective
Last update:2021-05-11, 1400/02/21
Update count:0
Registration date
2021-05-11, 1400/02/21
Registrant information
Name
Amir Ardalan Abdollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3336 3600
Email address
abdollahi.am@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-14, 1400/02/24
Expected recruitment end date
2021-10-16, 1400/07/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Supplementary Anesthesia of Mental Incisive Nerve Block, and Buccal Infiltration on Anesthetic Success of Inferior Alveolar Nerve Block, using 4% Articaine in Mandibular First Molars with Symptomatic Irreversible Pulpitis: A Double Blind Randomized Clinical Trial
Public title
The effect of Supplementary Anesthesia of Mental Incisive Nerve Block and Buccal Infiltration on the Success of Inferior Alveolar Nerve Block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with symptomatic irreversible pulpitis in the mandibular permanent first molars
Healthy adults aged 18 to 60 years
Normal periapical radiograph
Exclusion criteria:
Existence of systemic disease
Patients with severe stress
Patients with toothache at the time of study
Unstable heart disease
Allergy to 4% articaine anesthetic with epinephrine or latex
Facial or oral paraesthesia
Use any painkiller 12 hours before treatment
Taking psychotropic drugs
Asymptomatic irreversible pulpitis cases
Presence of periapical radiolucency
Pregnancy and lactation
Irreparable teeth and the presence of crowns on the teeth
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done in a simple, individual way with the help of Random.org and by the assistant. Patients were divided into three treatment groups using random numbers generated by Random.org.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be double-blind in the sense that both patients and the person evaluating the results will not be aware of the study conditions. The person in charge of analyzing and interpreting the data also does not know how to choose.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Alborz St., Alborz Dental Clinic
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2020-11-29, 1399/09/09
Ethics committee reference number
IR.UMSU.REC.1399.268
Health conditions studied
1
Description of health condition studied
irreversible puplitis
ICD-10 code
B95
ICD-10 code description
Streptococcus and staphylococcus as the cause of diseases classified to other chapters
Primary outcomes
1
Description
anesthesia
Timepoint
Once every 4 minutes, up to 15 minutes after anesthesia injection
Method of measurement
Electric Pulp Tester
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After inferior alveolar nerve block, supplementary anesthesia of mental nerve block is performed for this group .
Category
Treatment - Drugs
2
Description
Intervention group: After inferior alveolar nerve black, additional infiltration anesthesia is performed for this group.
Category
Treatment - Drugs
3
Description
Control group: Only Inferior alveolar nerve block anesthesia is performed for this group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alborz Dental Clinic of Urmia
Full name of responsible person
Amir Ardalan Abdollahi
Street address
Alborz Street
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
Abdollahi.am@umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Iraj Mohebbi
Street address
Alborz Street
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3223 4897
Email
Abdollahi.am@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?