Protocol summary

Summary
Our goal is to compare the amount of pain from immediate and delayed palatal injection following buccal infiltrate injection. In this randomized triple blinded, clinical trial, 92 patients referring to the dental school of Kermanshah University of Medical Sciences will be chosen. Inclusion criteria: People of 18 to 50 years of age, needing restorative treatment of maxillary premolar teeth. Exclusion criteria: use of sedatives and anti-depressant medications during two weeks prior to the injection. Patients are randomly divided into two groups of 46. Buccal injection will be performed using lidocain in one group and articaine in the other group; while palatal injection will be performed using lidocain in both groups. For each patient, injections will be performed twice with an interval of two weeks. Once, the palatal injection will be randomly performed immediately after the buccal injection, while the other time, it will be performed with a 10 minute delay. During the buccal injection, 1.8 milliliters of anesthetic agent, during 60 seconds, at 3 to 4mm penetration depth at the maxillary premolar vestibule will be delivered by the first operator, and during the palatal injection 0.3 milliliters will be delivered during 10 seconds, and 1cm far from the marginal gingiva of premolar teeth, at 3 to 4mm penetration depth by the second operator. The extent of pain from injection will be measured after buccal and palatal injections using the Visual Analogue Scale of pain. Palatal injection will be delivered by the second operator who will not be present in the room during the buccal injection. A dark tape will cover each anesthetic cartridge.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016071817880N4
Registration date: 2017-02-21, 1395/12/03
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-02-21, 1395/12/03
Registrant information
Name
Roohollah Sharifi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1722 2400
Email address
r.sharifi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2017-02-25, 1395/12/07
Expected recruitment end date
2017-03-18, 1395/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparative Study of the Amount of Pain from Palatal Injection Immediately and with a Delay Following Buccal Infiltrate Injection with Two Anesthetic Agents, Lidocain and Articain in Patients Requiring Restorative Treatment of Maxillary Premolar Teeth
Public title
The Comparison of the amount of pain from immediate and delayed palatal injection following buccal infiltrate injection using two anesthetic drugs
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: people with ages of 18 to 50 years and in good health; needing restorative treatment of maxillary premolar teeth. Exclusion criteria: the use of anesthetic drugs and sedatives and antidepressants during two weeks before the injection; allergic reactions to local anesthetic; edentulous at the premolar region of maxilla; medical history of cardiovascular and kidney diseases; any active pathology at the injection site; gastrointestinal bleeding or ulceration; pregnant and nursing patients.
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 92
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Randomized using sealed envelopes

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Ethics Committee of Kermanshah University of Medical Sciences, Shahid Beheshti Blvd
City
Kermanshah
Postal code
67146673159
Approval date
2016-07-13, 1395/04/23
Ethics committee reference number
KUMS.REC.1395.261

Health conditions studied

1

Description of health condition studied
Local anaesthetics
ICD-10 code
Y48.3
ICD-10 code description
Local anaesthetics

Primary outcomes

1

Description
The intensity of pain
Timepoint
Immediately after the buccal and palatal injection
Method of measurement
Based on the Visual Analogue Scale (VAS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Palatal injection of lidocain 2% with Epinephrine 1:80000, 10 min after buccal injection of articain 4% with Epinephrine 1:100000
Category
Treatment - Other

2

Description
Intervention group 2: Palatal injection of lidocain 2% with Epinephrine 1:80000, 10 min after buccal injection of lidocain 2% with Epinephrine 1:80000
Category
Treatment - Other

3

Description
Control group 1: Palatal injection of lidocain 2% with Epinephrine 1:80000, immediately after buccal injection of articain 4% with Epinephrine 1:100000
Category
Treatment - Other

4

Description
Control group 2: Palatal injection of lidocain 2% with Epinephrine 1:80000, immediately after buccal injection of lidocain 2% with Epinephrine 1:80000
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Endodontic, School of Dentistry, Kermanshah University of Medial Sciences.
Full name of responsible person
Dr Roohollah Sharifi
Street address
Shariati st.,
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Kourosh Hamzeei
Street address
Building No.2, Shahid Beheshti Boulverd, Vice Chancellor for Research, Kermafnshah University of Medical Sciences
City
Kermanshah
Grant name
_
Grant code / Reference number
_
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Kermanshah Dentistry School
Full name of responsible person
Maryam FarAra
Position
Dental student
Other areas of specialty/work
Street address
Opposite of the post office, Shora st, Dr Shariati st, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3722 2400
Fax
Email
maryam.farara.ir@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah Dentistry School
Full name of responsible person
Dr Roohollah Sharifi
Position
DDS., MSc
Other areas of specialty/work
Street address
Opposite of the post office, Shora st, Dr Shariati st, Kermanshah
City
Kermanshah
Postal code
6713954658
Phone
+98 83 3722 7151
Fax
+98 83 3722 2400
Email
roholahsharifi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah Dentistry School
Full name of responsible person
Maryam FarAra
Position
Dental student
Other areas of specialty/work
Street address
Opposite of the post office, Shora st, Dr Shariati st, Kermanshah
City
Kermanshah
Postal code
Phone
00
Fax
Email
maryam.farara.ir@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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