Study of the effect of Vibration on Needle Penetration and Injection Pain Following Maxillary Anterior Infiltrations and Inferior Alveolar Nerve Blocks Anesthesia in Patients Who Need Two Visit Root Canal Therapy: A Cross Over Study
Comparison of patient's self-reported pain in two injection methods with dental vibe and traditional method( without dental vibe) during needle penetration and local anesthesia injection
Design
A concealead, randomized using random number table, sham controlled clinical trial with a cross over design of 48 patients
Settings and conduct
Endodontic Department of Dental school of Shahid Beheshti University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria ; 12-65 years old systemically healthy patients who need two visit treatment for Root Canal therapy (RCT) in the maxilla or mandible
Exclusion criteria ; systemic diseases, allergy to Lidocaine or sulfites, using drug that affect the patient pain response (excessive alcohol consumption, narcotics, barbiturates), severe dental pain that needs emergency treatment.
Intervention groups
1.Anesthetic injection group( inferior alveolar nerve block or anterior maxillary infiltration) without vibration of dental vibe
2.Anesthetic injection group( inferior alveolar nerve block or anterior maxillary infiltration) with vibration of dental vibe
Study of the effect of Vibration on Needle Penetration and Injection Pain Following Maxillary Anterior Infiltrations and Inferior Alveolar Nerve Blocks Anesthesia in Patients Who Need Two Visit Root Canal Therapy: A Cross Over Study
Public title
Effectiveness of Vibration on Needle Penetration Pain and Intra-Oral Local Anesthesia Injection
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
patients who have 12-65 years old.
patients who are Systemically healthy.
Patients who need two visit treatment for root canal therapy(RCT) in the maxilla or mandible
Exclusion criteria:
patients who have systemic diseases.
patients who have allergy to Lidocaine or sulfites.
patient who used medications that affect the patient' pain response( excessive alcohol consumption, narcotics, barbiturates)
patients who have severe dental pain that needs emergency treatment.
Age
From 12 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Actual sample size reached:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization tecnique with table of random numbers will be used. For allocation concealment a nurse in department knew the code number of every patient and she informs it to clinician just before treatment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences, School Of Dentistry
Street address
School Of Dentistry, Shahid Beheshti University of Medical Sciences, Evin, Shahid Chamran highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2015-07-09, 1394/04/18
Ethics committee reference number
IR.SBMU.RIDS.1394.110
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
R52.9
ICD-10 code description
Generalized pain NOS
Primary outcomes
1
Description
Needle insersion pain in infiltration anesthesia in anterior site of maxilla
Timepoint
During needle insersion
Method of measurement
VAS
2
Description
Injection pain in infiltration anesthesia in anterior site of maxilla
Timepoint
During injection
Method of measurement
VAS
3
Description
Injection pain in inferior alveolar nerve block anesthesia in mandible
Timepoint
During injection
Method of measurement
VAS
4
Description
Needle insersion pain in inferior alveolar nerve block anesthesia in mandible
Timepoint
During needle insersion
Method of measurement
VAS
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Needle insertion and anesthesia injection with dental vibe that cause vibration in injection site
Category
Other
2
Description
Control group : Needle insertion and anesthesia injection without dental vibe
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti University Of Medical Sciences , Faculty Of Dentistry
Full name of responsible person
Dr nazanin zargar
Street address
Shahid Beheshti Dental School-Daneshjoo Boulevard-Velenjak-Shahid Chamran high way-Tehran-Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2240 3075
Email
N.zargar48@yahoo.com
Web page address
http://www.dentistry.sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University Of Medical Sciences , Faculty Of Dentistry