Protocol summary
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Study aim
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Comparison of the efficacy of 2% lidocaine anesthesia with epinephrine 1/ 100,000 and 3% mepivacaine in maxillary premolars with irreversible pulpitis
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Design
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Clinical trial with intervention and control group, prospective, randomized, double blinded, with a sample size of 76 patients
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Settings and conduct
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This study is done in a dental clinic. Before treatment, patients are given an explanation for the current research, and after receiving the necessary information, patients are given written consent for treatment. Patient treatment is done in a single session by a specific dentist. Encoding and giving anesthetic Carpools is done by one of the secretaries. After 7 minutes of injection of anesthetic solution, access to the endodontic cavity begins. Patient and the dentist are not aware of injactable solution. During accessing the endodontic cavity, the VAS chart is used to measure patient pain.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
The presence of maxillary premolars with irreversible pulpitis, People aged 18 to 65
Exclusion criteria:
We have to inject another anesthetic solution, Allergies to local anesthetics and sulfites, Pregnant women, Taking any medication 6 hours before referral, Having Systemic Disease
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Intervention groups
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Intervention group: 1.8 ml of 3% mipivacaine ( Novocol Pharmaceutical of Canada Inc.) is injected with the infiltration technique to the maxillary premolars.
Control group: 1.8 ml of 2% lidocaine with 1/100,000 epinephrine (Tehran Darou Pakhsh Pharmaceutical Mfg.Co.) is injected with the infiltration technique to the maxillary premolars.
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Main outcome variables
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Patient pain during treatment
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180818040824N1
Registration date:
2018-10-30, 1397/08/08
Registration timing:
retrospective
Last update:
2018-11-25, 1397/09/04
Update count:
1
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Registration date
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2018-10-30, 1397/08/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-02-20, 1396/12/01
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Expected recruitment end date
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2018-07-21, 1397/04/30
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Actual recruitment start date
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2018-02-20, 1396/12/01
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Actual recruitment end date
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2018-07-21, 1397/04/30
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Trial completion date
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2018-08-05, 1397/05/14
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Scientific title
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Comparison of anesthetic efficacy of 2% lidocaine with 1/100000 epinephrine and 3% mepivacaine in premolars of maxilla with irreversible pulpitis
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Public title
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Comparison of anesthetic efficacy of 2% lidocaine and 3% mepivacaine in premolars of maxilla with irreversible pulpitis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
The presence of maxillary premolars with irreversible pulpitis
People aged 18 to 65
Exclusion criteria:
We have to inject another anesthetic solution.
Allergies to local anesthetics and sulfites
Pregnant women
Taking any medication 6 hours before referral
Having Systemic Disease
The widening of periodontal ligament space
The presence of a periapical radiolucency
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
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Sample size
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Target sample size:
76
Actual sample size reached:
76
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Those who have entered the study are randomly assigned to one of the two intervention and control groups in the random numbers table. Making random sequences is such that the even numbers and the odd numbers associated with the lidocaine group and the mepivacaine group respectively.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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76 carpools (38 carpools containing 2% lidocaine with 1 /100,000 epinephrine and 38 carpools containing 3% mepivacaine ) are covered with paper and the codes A and B are inserted on it. The purpose is that the patient and the dentist is not aware of anesthetized injections, encoding is done by one of the secretaries.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-01-06, 1396/10/16
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Ethics committee reference number
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IR.YUMS.REC.1396.152
Health conditions studied
1
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Description of health condition studied
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Anesthetizing the teeth
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Patient pain during treatment
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Timepoint
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While providing access cavity
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Method of measurement
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Visual analogue scale
Intervention groups
1
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Description
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Intervention group: Infusion of buccal infiltration one cartridge (1.8 ml) local 3% mepivacaine anesthetic solution, manufactured by the Canadian Novocol
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Category
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Treatment - Drugs
2
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Description
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Control group: Infusion of buccal infiltration one cartridge (1.8 ml) local anesthetic 2% Lidocaine with 1/100,000 epinephrine, manufactured by Tehran Darou pakhsh
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Yasouj University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Data include patient gender, patient age, patient pain
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When the data will become available and for how long
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After publishing the article
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To whom data/document is available
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Based on the University's discretion
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Under which criteria data/document could be used
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According to the conditions that the University determines
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From where data/document is obtainable
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Yasouj University of Medical Sciences, Research Deputy
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What processes are involved for a request to access data/document
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Communicating with University's research unit
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Comments
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