Protocol summary
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Study aim
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The objective of this study was to compare the anesthetic efficacy of supplemental intraligamentary (PDL) injections of 4% articaine with 2% lidocaine in the first and second mandibular molars _diagnosed with irreversible pulpitis_ after an ineffective inferior alveolar nerve block (IANB), using the same anesthetic.
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Design
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Triple blind, consealed randomised, superiority, parallel group trial .A third phase study.
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Settings and conduct
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Endodontic Department, School of Dentistry,Shahid Beheshti University of Medical Sciences
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Participants/Inclusion and exclusion criteria
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Inclusion criteria include:patients who a) have no systemic diseases, b) are 18 years old or older, c) have a first or second vital mandibular molar with no sign of periapical pathosis in radiographs, and d) do not take any pain killers 12 h prior to the treatment.Exclusion criteria comprise a) teeth with more than 0.5 mm mobility and more than 3 mm probing depth in their mesial or distal surfaces, b) teeth with no vital coronal pulp tissue on access, and c) patients with hypersensitivity to lidocaine or articaine, pregnancy or lactation.
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Intervention groups
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1- Men and woman with a first or second mandibular molar who anesthetize with lidocaine
2-Men and women with a first or second mandibular molar who anesthetize with articaine
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Main outcome variables
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anesthetic efficacy of supplemental intraligamentary (PDL) injections of 4% articaine with 2% lidocaine in the first and second mandibular molars _diagnosed with irreversible pulpitis_ after an ineffective inferior alveolar nerve block (IANB), using the same anesthetic.
General information
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Reason for update
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to enter the actual recruitment start and end date
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2015100523253N2
Registration date:
2016-10-17, 1395/07/26
Registration timing:
prospective
Last update:
2019-12-31, 1398/10/10
Update count:
1
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Registration date
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2016-10-17, 1395/07/26
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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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Shahid Beheshti University of Medical Sciences
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Expected recruitment start date
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2015-09-23, 1394/07/01
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Expected recruitment end date
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2016-09-22, 1395/07/01
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Actual recruitment start date
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2016-10-23, 1395/08/02
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Actual recruitment end date
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2017-03-18, 1395/12/28
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Trial completion date
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2017-03-18, 1395/12/28
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Scientific title
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The comparison of anesthetic efficacy of Articaine versus Lidocaine in Inferior Alveolar Nerve Block plus Intraligamentary injections in mandibular molar teeth with irreversible pulpitis
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Public title
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Comparison of Articaine and Lidocaine as an anesthetic supplemental injection
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients older than 18 without any systemic diseases; First or second mandibular molar with irreversible pulpitis; No periapical lesion in radiography; Response to Electrical Pulp Tester; Prolonged response to the cold test
Exclusion criteria:
Allergic response to Lidocaine or Articaine; pre apical radiolucency; Lactate or pregnant women; Using analgesic drugs since 12 hours before the treatment; Mobility more than 0.5 mm; Probing more than 3 mm in mesial and distal; Severe dental pain that needs emergency treatment; Nonvital coronal pulp tissue; Teeth with full crown; No lip numbness after the Inferior Alveolar Nerve Block injection; No pulp exposure after removing caries
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Age
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From 18 years old to 70 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
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
64
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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All patients are divided into experimental groups using stratified permutations blocks randomization. Patients are stratified to 4 groups according to the gender and the type of the tooth (first or second mandibular molar). Then cases in every subgroup are randomly assigned into 2 groups of lidocaine and articaine with random block size of 4.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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Equal numbers of lidocaine and articaine cartridges, which are covered and given a code, are provided. To obtain allocation concealment, an assigned nurse is aware of the codes and, according to the groups (lidocaine or articaine), gives out the cartridges randomly. There is 1 code for each of the 2 cartridges packed together. One clinician completes the designated questionnaire and another one administers the injections. All the injections are given by the same clinician. Block and supplemental injections are done with the same anesthetic. This is a triple blind study; which means that the clinician who gives the injection, the patients, outcome assessor and the statistician are not aware of the anesthetic.
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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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2015-12-22, 1394/10/01
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Ethics committee reference number
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IR.SBMU.RIDS.REC.1394.63
Health conditions studied
1
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Description of health condition studied
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Irreversible pulpitis
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ICD-10 code
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B95
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ICD-10 code description
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Streptococcus and staphylococcus as the cause of diseases classified to other chapters
Primary outcomes
1
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Description
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Anesthesia
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Timepoint
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After Inferior Alveolar Nerve Block injection; After supplemental injection
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Method of measurement
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Electrical pulp tester
2
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Description
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Pulse
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Timepoint
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Before Inferior Alveolar Nerve Block injection; After Inferior Alveolar Nerve Block injection; After supplemtal injection
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Method of measurement
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Pulse-oximeter
3
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Description
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Pain during injection
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Timepoint
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During Inferior Alveolar Nerve Block and supplemental injection
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Method of measurement
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Heft Parker Visual Analog Scale
4
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Description
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Pain
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Timepoint
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After Inferior Alveolar Nerve Block and supplemental injection
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Method of measurement
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Heft Parker Visual Analog Scale
Intervention groups
1
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Description
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After Inferior Alveolar Nerve Block injection with Lidocaine with Epinephrine 1/80000, supplemental Intraligamentry injection with the same anesthetic material will be done.
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Category
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Treatment - Drugs
2
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Description
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After Inferior Alveolar Nerve Block injection with Articaine with Epinephrine 1/100000, supplemental Intraligamentry injection with the same anesthetic material will be done.
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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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Shahid Beheshti 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available