Protocol summary

Study aim
The aim of this study was to compare the anesthetic technique efficacy between Crestal and inferior alveolar nerve block techniques in pain control during supra-gingival and sub-gingival plaque removal in the patients referred to the Periodontologist office in Urmia in 2021.
Design
NB group
Settings and conduct
In each group the relevant according to the same protocol
Participants/Inclusion and exclusion criteria
: هدف از این مطالعه مقایسه بی حسی به روش کرستال با بی حسی به روش بلاک آلوئولار تحتانی در کنترل درد حین برداشت جرم های فوق و زیر لثه ای در بیماران مراجعه کننده به مطب پریودونتیست در سال 1400 می باشد
Intervention groups
CA group
Main outcome variables
Anesthesia success

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210114050033N1
Registration date: 2021-04-22, 1400/02/02
Registration timing: registered_while_recruiting

Last update: 2021-04-22, 1400/02/02
Update count: 0
Registration date
2021-04-22, 1400/02/02
Registrant information
Name
Saman Taram
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3336 3600
Email address
taram.saman@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-12, 1399/11/24
Expected recruitment end date
2021-07-14, 1400/04/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between Crestal and Inferior Alveolar Nerve Block in Pain control during Supra-gingival and Sub-gingival Scaling
Public title
Crestal Anesthesia in Scaling
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients seeking dental scaling
Exclusion criteria:
1. Medically-suppressed patients including patients with hypertension and diabetes mellitus Smoking Alcoholism Patient with analgesics consumption during last 24 hours.
Age
No age limit
Gender
Both
Phase
1
Groups that have been masked
  • Participant
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided into two equal groups (n = 32) using computer-generated random of sequence numbers
Blinding (investigator's opinion)
Single blinded
Blinding description
بیمار از تکنیک بی حسی آگاه نخواهد بود.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Urmia ethical committee
Street address
Alborz
City
Urmia
Province
West Azarbaijan
Postal code
4432261512
Approval date
2021-03-11, 1399/12/21
Ethics committee reference number
IR.UMSU.REC.1399.308

Health conditions studied

1

Description of health condition studied
All were normal
ICD-10 code
12
ICD-10 code description
12

Primary outcomes

1

Description
Succes
Timepoint
intraoperative
Method of measurement
Pain report

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Urmia Alborz Dental Clinic
Full name of responsible person
Ehsan Khashabi
Street address
Urmia Alborz Stu
City
Urmia
Province
West Azarbaijan
Postal code
32412252
Phone
+98 44 3336 3600
Email
Ehsankhashabi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Urmia university of medical science
Full name of responsible person
Ehsan Khashabi
Street address
Urmia Alborz Stu
City
Urmia
Province
West Azarbaijan
Postal code
32242215
Phone
+98 44 3336 3600
Email
Ehsankhashabi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urmia university of medical science
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
Urmia university of medical science
Full name of responsible person
Ehsan Khashabi
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Urmia alborz st
City
Urmia
Province
West Azarbaijan
Postal code
32242215
Phone
+98 44 3336 3600
Email
Ehsankhashabi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Urmia university of medical science
Full name of responsible person
Ehsan Khashabi
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Urmia Alborz St
City
Urmia
Province
West Azarbaijan
Postal code
32252215
Phone
009833363600
Email
Ehsankhashabi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Urmia university of medical science
Full name of responsible person
Ehsan Khashabi
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Urmia Alborz St
City
Urmia
Province
West Azarbaijan
Postal code
32242215
Phone
+98 44 3336 3600
Email
Ehsankhashabi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
It is not well determined
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 are no checklist
When the data will become available and for how long
for 6 months after study complete
To whom data/document is available
Study authors
Under which criteria data/document could be used
Getting consent from authors
From where data/document is obtainable
from study article
What processes are involved for a request to access data/document
contact to correspond author
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