This study was designed to evaluate the effectiveness of buccal articaine anesthesia compared to lidocaine for achieving palatal anesthesia in Maxillary dental procedures.
Design
A double-blind, crossover clinical trial with a control group and an intervention group will be conducted on 34 patients.
Settings and conduct
The study was conducted at the School of Dentistry, Isfahan University of Medical Sciences, Iran, as a double-blind crossover clinical trial. Participants received buccal injections of both anesthetic agents, articaine and lidocaine, with a washout period observed between administrations. The choice of the initial anesthetic agent and the side of the maxilla for the first injection were randomized. Blinding was ensured by coloring the cartridges in two distinct shades (blue and red), so that both the operator and the patient remained unaware of the anesthetic being administered.
Participants/Inclusion and exclusion criteria
All candidates for bilateral Maxillary implants will be included in the study. Subjects should not have the following conditions: Age less than 18 years, History of trauma or nasal surgery, History of psychiatric disorder, Congenital anomalies, Peripheral neuropathy or presence of sensory deficits in the facial area prior to surgery, Uncontrolled systemic conditions
Intervention groups
Intervention group: Patients will receive 0.9 mL of articaine at the buccal sites of the maxillary canine and first molar.
Control group: Patients will receive 0.9 mL of lidocaine at the same buccal sites of the maxillary canine and first molar.
In both groups, the drug will be administered by injection using the infiltration technique.
Main outcome variables
Change in palatal mucosal sensory and pain threshold after buccal anesthetic injection.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131205015665N8
Registration date:2025-09-05, 1404/06/14
Registration timing:prospective
Last update:2025-09-05, 1404/06/14
Update count:0
Registration date
2025-09-05, 1404/06/14
Registrant information
Name
Milad Etemadi-Shalamzari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 1391 3237
Email address
etemadi@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-06, 1404/06/15
Expected recruitment end date
2025-09-11, 1404/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of palatal mucosa anesthesia due to infiltration of lidocaine compared to articaine in the buccal region of maxilla
Public title
Evaluation of palatal mucosa anesthesia due to infiltration of lidocaine compared to articaine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All people who are candidates for implants on both sides of the maxilla
Exclusion criteria:
Age less than 18 years
History of trauma or nasal surgery
History of psychiatric disorder
Congenital anomalies
Peripheral neuropathy or presence of sensory deficits in the facial area prior to surgery
Uncontrolled systemic conditions
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
34
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
anesthesia during maxillary dental procedures. The study will be conducted as a randomized, double-blind, crossover clinical trial at the School of Dentistry, Isfahan University of Medical Sciences, Iran.
Participants will be candidates for bilateral maxillary implant placement, with both sides scheduled for surgery in a single session, as performing bilateral maxillary implant surgery in one session is a common practice. During the session, buccal injections of both anesthetic agents (articaine and lidocaine) will be administered with an appropriate washout period to ensure that the effect of the first anesthetic is eliminated. Injections will be performed in the buccal region of the maxillary canine and first molar on both sides, and participants will be blinded to the type of anesthetic used.
Considering that systemic conditions and pain thresholds may vary between treatment sessions, both sides will be evaluated within the same session while observing the washout period. A computerized injection device will be used to standardize the injection rate. Randomization will be performed and managed using an online software. For operator blinding, anesthetic cartridges will be color-coded (e.g., blue and red) so that the operator is unaware of the type of anesthetic.
Prior to each injection, and after drying the buccal mucosa of the maxillary canine and first molar, a lidocaine gel will be applied to the site for one minute using an applicator.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2025-07-26, 1404/05/04
Ethics committee reference number
IR.MUI.DHMT.REC.1404.080
Health conditions studied
1
Description of health condition studied
Comparative evaluation of the effectiveness of articaine and lidocaine for achieving palatal anesthesia.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of change in pain threshold
Timepoint
Before and 5 minutes after injection
Method of measurement
Light Touch (Semmes Weinstein monofilament) test
2
Description
The amount of change in sensory threshold
Timepoint
Before and 5 minutes after injection
Method of measurement
Light Touch (Semmes Weinstein monofilament) test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Participants are randomly assigned to receive articaine anesthesia on one side of the maxilla (left or right) which half a cartridge (equivalent to 0.9 mL) was injected at the canine region and the same amount at the first maxillary molar region using the infiltration technique.
Category
Treatment - Drugs
2
Description
Control group: Participants randomly receive lidocaine on the contralateral side of the maxilla (e.g., the left side if articaine was administered on the right) which half a cartridge (equivalent to 0.9 mL) was injected at the canine region and the same amount at the first maxillary molar region using the infiltration technique.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Milad Etemadi
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5552
Email
dnt@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Rouhollah Nasseri
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5521
Email
dnt@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Milad Etemadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5521
Email
etemadi@dnt.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Milad Etemadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5521
Email
etemdi@dnt.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Milad Etemadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5521
Email
etemdi@dnt.mui.ac.ir
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
All data is potentially shareable after de-identifying individuals.
When the data will become available and for how long
Access period starts 6 months after results are published
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
.No other condition
From where data/document is obtainable
Address: Faculty of Dentistry, Isfahan University of Medical Sciences, Tel: 03137925521
What processes are involved for a request to access data/document
.10 day after sending the request,data will be accessible