The purpose is to evaluate the effect of acupuncture on the success of Inferior alveolar nerve block injection for teeth with irreversible pulpitis in a placebo controlled ,triple blind randomized clinical trials study. 40 Patients with spontaneous or nightly pain in first or second mandibular molars that rate their pain 54 mm or more on VAS, randomly are divided into two groups (case or control) of 20 patient each. 15 minutes after acupuncture (in case group) or schema acupuncture (in control group), Inferior alveolar nerve block injection is administered by an endodontist. In case of no lip numbness, the patient will be excluded from the study. 15 minutes later, access cavity preparation is initiated and if there is pain, supplemental anaesthesia will be administered and recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013121615814N1
Registration date:2014-06-04, 1393/03/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-04, 1393/03/14
Registrant information
Name
Shahrzad Jalali
Name of organization / entity
Qazvin University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3335 3061
Email address
jalali.shahrzad@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Qazvin University of Medical Sciences
Expected recruitment start date
2014-05-31, 1393/03/10
Expected recruitment end date
2014-08-01, 1393/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Acupuncture on the success of Inferior Alveolar Nerve block anesthesia for teeth with Irreversible Pulpitis
Public title
The effect of Acupuncture on dental anaesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Complete healthy or controlled mild systemic disorders(ASA I, II); Patients with spontaneous or nightly pain in first or second mandibular molars that rate their pain 54 mm or more on VAS.
Exclusion Criteria: Patients with contraindication or sensitivity to lidocaine or epinephrine; Taking medication for chronic pain; History of acupuncture; Coagulation disorders; Lactation; Pregnancy; Using any type of analgesic medication in the preceding 6 hours before the treatment; Teeth with extensive caries; Casting coronal restoration; Advanced periodontal disease.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Shahid Bahonar Boulevard
City
Qazvin
Postal code
3418-5745
Approval date
2014-05-12, 1393/02/22
Ethics committee reference number
28/20/8739
Health conditions studied
1
Description of health condition studied
Irreversible Pulpitis
ICD-10 code
k04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
The need for supplemental anaesthesia
Timepoint
30 to 45 minutes after intervention
Method of measurement
Administering or not
Secondary outcomes
1
Description
Pain
Timepoint
Before intervention and 30 to 45 minutes after intervention
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group: Acupuncture, needle insertion on Hegu point on the hand
Category
Treatment - Other
2
Description
Control group: Painful stimulation without Acupuncture specific needle insertion
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvin Dental Faculty
Full name of responsible person
Shahrzad Jalali
Street address
Dental Faculty; Shahid Bahonar Boulevard
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Qazvin University of Medical Sciences
Full name of responsible person
Mehri Mashatan
Street address
Shahid Bahonar Boulevard
City
Qazvin
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, Qazvin University of Medical Sciences