A comparison between anesthetic efficacy of articaine and lidocaine secondary endodontic treatment in mandibular molar teeth : A randomized clinical trial
Determination and Comparison of the Success of Articaine and Lidocaine Anesthesia During and After Endodontic Retreatment in Mandibular Molars: A Randomized Clinical Trial
Design
A controlled clinical trial, with parallel groups, double-blind, randomized, using the Sealed Envelope website for randomization.
Settings and conduct
This double-blind clinical trial will be conducted on 60 patients who have been referred to the Kerman Dental School and have asymptomatic, endodontically treated mandibular molars diagnosed as requiring retreatment. The patients will be randomly allocated into two groups.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Asymptomatic patients with mandibular molars requiring retreatment that are restorable.
Exclusion Criteria: Symptomatic patients with mandibular molars not requiring retreatment or that are non-restorable.
Intervention groups
Intervention group: Use of supplementary infiltration injection of Articaine after mandibular block injection with Lidocaine in root canal retreatment of manibular molars
Control group: Use of mandibular block injection with Lidocaine in root canal retreatment of manibular molars
Main outcome variables
Investigating the effect of the type of anesthetic agent on pain level during retreatment of asymptomatic mandibular first and second molars؛ Investigating the effect of the anesthetic technique on pain level during retreatment of asymptomatic mandibular molars؛ Investigating the effect of the anesthetic technique on pain level after retreatment of asymptomatic mandibular molars؛ Assessing the quality of life before, during, and after retreatment of asymptomatic mandibular molars using either lidocaine block or articaine infiltration anesthesia.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260122068639N1
Registration date:2026-02-16, 1404/11/27
Registration timing:registered_while_recruiting
Last update:2026-02-16, 1404/11/27
Update count:0
Registration date
2026-02-16, 1404/11/27
Registrant information
Name
mohammad moradinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 918 599 2584
Email address
m.moradinia.g@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-02-14, 1404/11/25
Expected recruitment end date
2026-04-25, 1405/02/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between anesthetic efficacy of articaine and lidocaine secondary endodontic treatment in mandibular molar teeth : A randomized clinical trial
Public title
anesthesia in root canal retreatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
– First or second mandibular molars with a history of root canal treatment having a Periapical Index (PAI) score of 1, 2, or 3.
Teeth previously treated with root canal therapy but unsuccessful and having developed apical periodontitis (AP).
Individuals with a spontaneous pain score of less than 54 mm on the HP-VAS scale
Teeth with radiographically poor-quality root canal fillings.
Teeth with failed or insufficient coronal restoration requiring root canal retreatment.
Patients aged 18 to 65 years
Patients with ASA I and ASA II
Patients without acute pain or extracoral swelling
Patients with acute apical abscess
Patients who voluntarily participate in the study and are available for follow-up
Absence of severe periodontal problem in the tooth in question
Teeth with prefabricated posts
Exclusion criteria:
Individuals with a spontaneous pain score greater than 54 on the HP-VAS scale
Patients whose retreatment requires two sessions.–
Teeth with internal or external root resorption
Teeth with vertical root fracture or dental crack
Teeth with open or immature apex
Patients with systemic diseases (such as bone metabolism disorders)
Patients taking medications affecting bone metabolism
Patients with acute pain who have taken analgesics in the past 24 hours
Patients who did not attend follow-up sessions
third molars
Presence of severe periodontal disease rendering the tooth unsuitable for endodontic treatment
Periodontal probing depth greater than 3 mm.
Root canal treatment extending beyond the canal length and over instrumentation
Teeth with cast posts or broken files inside the canal
Patients with contraindications to NSAIDs
Patients who experience treatment errors during retreatment
Patients who are accidentally over-instrumented during the procedure
Patients in whom post-operative radiography shows any extrusion of the root canal filling material
Teeth with extensive caries making restoration impossible
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into two groups, Group A and Group B: Lidocaine VS Articaine (Men) and Lidocaine VS Articaine (Women), using the website www.SealedEnvelope.com. Each patient, after entering the study, will determine their group by selecting the word "Randomization".
Blinding (investigator's opinion)
Double blinded
Blinding description
The anesthetic injection is performed by two endodontic specialty residents (other than the main operator) who have rehearsed and calibrated the block and infiltration injection techniques in a separate session.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kerman University of Medical Sciences Ethics Committee
Street address
Kerman, Jomhori Esalmi Blvd, Shafa Street
City
Kerman
Province
Kerman
Postal code
7618759689
Approval date
2025-11-02, 1404/08/11
Ethics committee reference number
IR.KMU.REC.1404.426
Health conditions studied
1
Description of health condition studied
Root canal retreatment of mandibular molars
ICD-10 code
K04.9
ICD-10 code description
Other and unspecified diseases of pulp and periapical tissues
Primary outcomes
1
Description
Pain score in the Heft-Parker Visual Analog Scale (HP-VAS) questionnaire
Timepoint
Before the start of treatmentDuring the injectionDuring removal of the coronal restorationDuring removal of gutta-percha from the canalsDuring canal preparation and irrigationDuring obturationImmediately after completion of the procedure,6 hours after the procedure,12 hours after the procedure, 24 hours after the procedure, 2 days after the procedure, 3 days after the procedure،7 days after the procedure
Method of measurement
Heft-Parker Visual Analog Scale (HP-VAS) questionnaire
Secondary outcomes
1
Description
quality of life score
Timepoint
Before the start of treatment, 7 days after treatment
Method of measurement
Oral Health Impact Profile-14 (OHIP-14) questionnaire
Intervention groups
1
Description
Intervention group: Use of supplementary infiltration injection of Articaine after mandibular block injection with Lidocaine in root canal retreatment of manibular molars
Category
Treatment - Other
2
Description
Control group: Use of mandibular block injection with Lidocaine in root canal retreatment of manibular molars
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
School of dentistry, Kerman University of Medical sciences
Full name of responsible person
Hamed Manouchehri far
Street address
Kerman, Jomhori Eslami Blvd, Shafa street
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
m.moradinia.g@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hamid Sharifi
Street address
Kerman, Beginning of Haft Bagh-e Alavi Axis, University of medical sciences Campus
City
Kerman
Province
Kerman
Postal code
7616910002
Phone
+98 34 3132 5700
Email
m.moradinia.g@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hamed Manouchehrifar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shafa street . Kerman university of medical sciences
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 914 315 4323
Fax
Email
hamed_man61@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hamed Manouchehrifar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shafa street . Kerman university of medical sciences
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 914 315 4323
Fax
Email
hamed_man61@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hamed Manouchehrifar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shafa street . Kerman university of medical sciences
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 914 315 4323
Fax
Email
hamed_man61@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
A portion of the data, such as information related to the main message or similar items, can be shared
When the data will become available and for how long
The access period begins one year after the results are published
To whom data/document is available
It will only be available to researchers employed at academic and scientific institutions
Under which criteria data/document could be used
Use of the information is permitted solely for scientific purposes
From where data/document is obtainable
Email address: m.moradinia.g@gmail.com
What processes are involved for a request to access data/document
By sending an email to the mentioned address, the documentation will reach them after one week