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The effect of local cooling on pain during injection, root canal therapy, and after treatment in mandibular molars with irreversible pulpitis

Protocol summary

Summary
The aim of the present study is to evaluate the effect of local cooling on pain perception during local anesthesia injection, root canal therapy and post-operative pain in mandibular molars with irreversible pulpitis. The inclusion criteria include persons without systemic diseases with minimum age of 18 years old, having first or second mandibular molar tooth diagnosed with irreversible pulpitis, normal periapical radiographic appearance, without percussion sensitivity, having no pain before treatment; and absence of taking medication within 6 hours before treatment. The exclusion criteria are: presence of sensitivity to lidocaine with 1:80,000 epinephrine, periodontal ligament widening; and pregnancy or lactation. In a randomized double-blinded clinical trial, one hundred patients will be divided into two groups of 50 patients each. In group I, patients will receive frozen gel packs for 5 minutes prior to inferior alveolar nerve block injection, while in the second group a gel pack at room temperature would be used. Patients will be asked to rate their pain using a Visual Analogue Scale immediately after the injection, during root canal therapy and at times 6, 12, 24, 36, 48, and 72 hours after treatment. Two different persons are responsible for applying the gel packs and performing root canal treatments. The practitioner who performs root canal therapy and statistic analyzer remains unaware of the groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013101214985N1
Registration date: 2014-01-31, 1392/11/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-01-31, 1392/11/11
Registrant information
Name
Maryam Raoof
Name of organization / entity
Kerman University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 34 1211 8071
Email address
m_raouf@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Kerman University of Medical Sciences
Expected recruitment start date
2013-11-23, 1392/09/02
Expected recruitment end date
2014-04-14, 1393/01/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of local cooling on pain during injection, root canal therapy, and after treatment in mandibular molars with irreversible pulpitis
Public title
The effect of local cooling on pain related to root canal therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Persons without systemic diseases with minimum age of 18 years old; having first or second mandibular molar tooth diagnosed with irreversible pulpitis; normal periapical radiographic appearance; without percussion sensitivity; having no pain before treatment; absence of taking medication within 6 hours before treatment. Exclusion criteria: Presence of sensitivity to lidocaine with 1:80,000 epinephrine; presence of periodontal ligament widening; pregnancy or lactation.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Two different persons are responsible for applying the gel packs and performing root canal treatments. The practitioner who performs root canal therapy and statistic analyzer remain unaware of the groups.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Kerman University of Medical Sciences
Street address
Research Vice-Chancellor Office, Ebn Sina Street, Jahad Blvd, Kerman, Iran
City
Kerman
Postal code
Approval date
2013-04-08, 1392/01/19
Ethics committee reference number
ka/92/139

Health conditions studied

1

Description of health condition studied
Irreversible pulpitis of first or second mandibular molars
ICD-10 code
k04.0
ICD-10 code description
بیماریهای پالپ و پری آپیکال

Primary outcomes

1

Description
Pain degree
Timepoint
During needle insertion
Method of measurement
Visual Analogous Scale (VAS)

2

Description
Pain degree
Timepoint
During injection
Method of measurement
Visual Analogous Scale (VAS)

3

Description
Pain degree
Timepoint
During treatment
Method of measurement
Visual Analogous Scale (VAS)

4

Description
Pain degree
Timepoint
At times 6, 12, 24, 36, 48 and 72 hours after treatment
Method of measurement
Visual Analogous Scale (VAS)

Secondary outcomes

empty

Intervention groups

1

Description
Inferior alveolar nerve block after cooling of the skin over the injection site
Category
Treatment - Other

2

Description
Inferior alveolar nerve block without cooling of the skin over the injection site
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Dentistry، Kerman University of Medical Sciences.
Full name of responsible person
Siamak Samanipoor
Street address
Endodontic Department, School of Dentistry, Shafa Street, Jomhoori Eslami Boulevard, Kerman, Iran
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza Malekpour Afshar
Street address
Research Vice-Chancellor Office, Ebn Sina Street, Jahad Blvd, Kerman, Iran
City
Kerman
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
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
Kerman University of Medical Sciences
Full name of responsible person
Siamak Samanipoor
Position
Resident of Endodontics
Other areas of specialty/work
Street address
Department of Endodontics, School of Dentistry, Shafa Street, Jomhoori Eslami Blvd, Kerman, Iran
City
Kerman
Postal code
Phone
+98 34 1247 7388
Fax
+98 34 1211 8073
Email
s_samanipoor@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Maryam Raoof
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Endodontics, School of Dentistry, Shafa Street, Jomhoori Eslami Blvd, Kerman, Iran
City
Kerman
Postal code
Phone
+98 34 1211 9021
Fax
+98 34 1211 8073
Email
m_raouf@kmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Siamak Samanipoor
Position
Resident of Endodontics
Other areas of specialty/work
Street address
Department of Endodontics, School of Dentistry, Shafa Street, Jomhoori Eslami Blvd, Kerman, Iran
City
Kerman
Postal code
Phone
+98 34 1247 7388
Fax
+98 34 1211 8073
Email
s_samanipoor@yahoo.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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