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Evaluation the effect of admixture of clonidine and lidocaine in comparison with epinephrine and lidocaine on postoperative pain after single visit root canal therapy of mandibular molars with irreversible pulpitis

Protocol summary

Summary
The purpose of this study is to evaluate the efficacy of admixture of clonidine and lidocaine in comparison with admixture of epinephrine and lidocaine on postoperative pain after single visit root canal therapy of mandibular molars with irreversible pulpitis. A randomized double-blind study will designed. One hundred emergency patients who attended faculty of dentistry, Isfahan university of medical sciences in the range of 18-60 years old and physical status ASA I with at least one first or second mandibular molars having diagnosed irreversible pulpitis, will involved in this study. Patients taking beta-blockers or any opioids preoperatively, drug abusers, pregnant or nursing mothers, those with a contraindication for the use of clonidine and those known to be allergic will excluded from the study. Patients randomly received 1.8 mL of 2% lidocaine with clonidine (15 μg/mL) or 1.8 mL of 2% lidocaine with epinephrine (12.5 μg/mL), using a conventional IANB technique. Root canal therapy will done in a single visit appointment. Patients will asked to recorded their pain on a Heft-Parker visual analogue scale (VAS) at 6, 12, 24, 36, 48, and 72 hours after treatment. They also will asked to record the number of analgesic tables that they will use.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201512076578N33
Registration date: 2015-12-18, 1394/09/27
Registration timing: na

Last update:
Update count: 0
Registration date
2015-12-18, 1394/09/27
Registrant information
Name
Elham Shadmehr
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1625 0955
Email address
elham.shadmehr@gmail.com
Recruitment status
Not enough for processing
Funding source
Vice Chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2006-03-21, 1385/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of admixture of clonidine and lidocaine in comparison with epinephrine and lidocaine on postoperative pain after single visit root canal therapy of mandibular molars with irreversible pulpitis
Public title
The effect of admixture of clonidine and lidocaine as dental anesthesia solution on postoperative pain
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criteria: 18 years of age up to 60; in good health(ASA I (classification of the American Society of Anesthesiologists)); having at least one mandibular molar teeth with irreversible pulpitis criteria The exclusion criteria: Patients taking beta-blockers or being medicated with any opioids preoperatively; drug abusers; pregnant or nursing mothers; those with a contraindication for the use of clonidine; those known to be allergic to clonidine; those with orofacial infection/inflammation
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Five-digit random numbers are chose by using computer random number and are written on a label on the anesthetic solutions. And also each one will kept in a separate sealed opaque envelope. All these procedure is done by a third person who has no clue and has not involved in the rest of the study. Patients with simple random sampling protocol choose the envelope to determine which anesthetic solution will be administered. Only the random number is used on the data collection sheets to further blind the experiment.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Department of Isfahan University of Medical Sciences
Street address
Isfahan
City
Isfahan
Postal code
81723477
Approval date
2004-09-22, 1383/07/01
Ethics committee reference number
393430

Health conditions studied

1

Description of health condition studied
Irreversible pulpitis
ICD-10 code
KO4.0
ICD-10 code description
Diseases of pulp and periapical tissues, Pulpitis

Primary outcomes

1

Description
Pain
Timepoint
6, 12, 24, 36, 48, 72
Method of measurement
Heft-Parker visual analogue scale (VAS)

Secondary outcomes

empty

Intervention groups

1

Description
Control group : 1.8 mL of 2% lidocaine with epinephrine 1:80000 (L+Epi) at a concentration of 12.5 μg/mL (Persicaine, Darupakhsh, Tehran, Iran) applied by using conventional inferior alveolar nerve block injection technique.
Category
Treatment - Drugs

2

Description
Intervention group: 1.8 mL of 2% lidocaine with clonidine (L+Clo) at a concentration of 15 μg/mL applied by using conventional inferior alveolar nerve block injection technique.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Torabinejad research center
Full name of responsible person
Dr. Elham Shadmehr
Street address
Shohadaye sofe street
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Isfahan University of Medical Sciences
Full name of responsible person
Tavangar Mr.
Street address
Dental School, Isfahan University of Medical Sciences.
City
Isfahan
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 of Isfahan 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
Isfahan university of medical sicence
Full name of responsible person
ِDr. Elham Shadmehr
Position
Assistant professor of endodontic, Isfahan University of Medical Sciences
Other areas of specialty/work
Street address
Hezar Jerib street
City
Isfahan
Postal code
87986546
Phone
+98 31 3440 8524
Fax
Email
elham.shadmer@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Assistant professor of endodontic, Isfahan University of Medical Sciences
Full name of responsible person
Dr Elham Shadmehr
Position
assistant of endodontics
Other areas of specialty/work
Street address
Hezar Jarib
City
Isfahan
Postal code
87986546
Phone
+98 31 3440 8524
Fax
Email
elham.shadmehr@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of medical sciences
Full name of responsible person
Dr Elham Shadmehr
Position
Assistant professor of endodontic
Other areas of specialty/work
Street address
Isfahan
City
Isfahan
Postal code
87986546
Phone
+98 31 3440 8524
Fax
Email
elham.shadmehr@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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