Protocol summary
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Study aim
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Comparison of the anesthetic efficacy of articaine 4% as supplemental intraligamentary injection with buccal Infiltration in posterior mandibular teeth with irreversible pulpitis.
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Design
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Prospective randomized clinical trial
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Settings and conduct
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All the patients will receive inferior alveolar nerve block(1.5ml) and long buccal(0.3 ml) injections of lidocaine 2% with epinephrine 1/100000. After 15 minutes the patients without lip numbness will be excluded. The teeth will be examined by cold test and electrical pulp tester and the patients indicate their pain on Heft Parker Visual Analogue Scale. The pulse will be recorded. If the electrical pulp test number will be under 80 we will consider supplemental injection. All the injections will be done by one person. After 5 minutes the teeth will be examined by cold test and electrical pulp tester and the patients will indicate their pain and the pulse will be recorded and the access cavity will be prepared and initial filing will be done. If the patients report moderate to severe pain during these procedures another anesthetic technique will be considered for them and will be reported as a failure
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Participants/Inclusion and exclusion criteria
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One hundred patients in Endodontic ِDepartment, Scchool of Dentistry, Shahid Beheshti University of Medical Sciences. Patients with a first or second vital mandibular molar without spontanous pain,with positive response to electrical pulp tester and prolonged response to cold test.
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Intervention groups
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Subgroup 1: 0.4 ml of the supplemental intraligamentary injection with articaine 4% with epinephrine 1/80000. Subgroup 2:1.8 ml of the supplemental buccal infiltration injection with articaine 4% with epinephrine 1/80000.
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Main outcome variables
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The success of the injections was defined as the ability to prepare access cavity and initial filing with no or mild pain (0 or less than 54 mm on HP-VAS).
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:
IRCT2015072023253N1
Registration date:
2016-08-17, 1395/05/27
Registration timing:
prospective
Last update:
2020-07-19, 1399/04/29
Update count:
1
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Registration date
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2016-08-17, 1395/05/27
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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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2016-04-08, 1395/01/20
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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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Comparison of the anesthetic efficacy of articaine 4% as supplemental intraligamentary injection with buccal infiltration in posterior mandibular teeth with irreversible pulpitis
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Public title
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Comparison of the anesthetic efficacy of articaine 4% in two supplemental anesthetic injections
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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 molars with irreversible pulpitis
No periapical lesion in radiography
Prolonged response with moderate to severe pain to cold test and check the vitality by electrical pulp tester
Vital coronal pulp tissue
Exclusion criteria:
Allergy to lidocaine or articaine
Lactate or pregnancy
Using analgesic drugs since 12 hours before the treatment
Mobility more than 0.5mm
Probing more than 3mm
Severe dental pain needs emergency treatment
Teeth with full crowns
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 60 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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- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
100
Actual sample size reached:
100
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Stratified permutations blocks randomization
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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All injections are done by a single clinician. The principle investigator or outcome assessor is different from the operator who administers anesthesia and root canal therapy. So he is blind to anesthetic technique used. The patients and the clinician who administered anesthesia are not blind to anesthetic technique. The statistician who analyzed the data was blinded to the procedure.
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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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2015-11-01, 1394/08/10
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Ethics committee reference number
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IR.SBMU.RIDS.REC.1394.24
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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k04.0
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ICD-10 code description
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Pulpitis
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 supplemental injection
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Method of measurement
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Pulse-oximetre
3
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Description
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Pain during injection
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Timepoint
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Pain during inferior alveolar nerve block and supplemental injection
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Method of measurement
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Heft Parker Visual Analogue 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 Analogue Scale
Intervention groups
1
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Description
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After inferior alveolar nerve block injection with lidocaine and epinephrine 1/80000, the supplemental buccal infiltration injection with articaine 4% and epinephrine 1/100000 will be done
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Category
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Treatment - Other
2
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Description
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After inferior alveolar nerve block injection with lidocaine and epinephrine 1/80000, the intraligamentry injection with articaine 4% and epinephrine 1/100000 will be done
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Category
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Treatment - Other
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 Behsehti 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