Comparison of the effect of local pressure and topical anesthesia with lidocaine/ prilocaine cream (EMLA) on pain during infiltration of maxillary canine teeth: Randomized clinical trial
Study aim : to compare the effect of local pressure and topical anesthesia with lidocaine / prilocaine cream (EMLA) on pain during infiltration of maxillary canine teeth. Study design : clinical trial,randomized, triple blind, controlled with placebo, single center, phase 3 of trial. Table of random numbers is used for randomization in this study.Target population of the study : volunteer dental students educating at different grades. Main inclusion criteria: intact or with minimal caries and restoration maxillary canine teeth with normal view in periapical radiography and exclusion criteria is the patients with tooth pain at the time of study. Sample size is 140(35 per group). Interventions of this study:
Group 1: Before administration of anesthesia, finger pressure would be applied on the alveolar mucosa at injection site in one side (experimental side). The finger pressure will be applied on the tooth crown in opposite side (control side). Group 2: Before administration of anesthesia, 5% EMLA cream would be applied on the injection site(experimental side). Placebo will be applied in the opposite side(control side).Group3: Before administration of anesthesia, finger pressure would be applied on the alveolar mucosa at injection site on one side and on the opposite side 5% EMLA cream would be used. Group 4: Before administration of anesthesia, 5% EMLA cream would be applied on the injection site and on the opposite side 20% benzocaine gel would be used.
Primary outcome: Pain intensity (visual analogue scale)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015120925456N1
Registration date:2016-03-03, 1394/12/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-03-03, 1394/12/13
Registrant information
Name
Amir Ardalan Abdollahi
Name of organization / entity
Department of Endodontics, Faculty of Dentistry,Tabriz University of Medical sciences Univers
Country
Iran (Islamic Republic of)
Phone
+98 41 3667 9135
Email address
amin.salemmilani@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Dental and Periodontal Research Center, Dental Faculty of Tabriz University of Medical Science
Expected recruitment start date
2015-10-18, 1394/07/26
Expected recruitment end date
2016-01-20, 1394/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of local pressure and topical anesthesia with lidocaine/ prilocaine cream (EMLA) on pain during infiltration of maxillary canine teeth: Randomized clinical trial
Public title
Comparison of the effect of local pressure and topical anesthesia with lidocaine /prilocaine cream (EMLA) on pain during infiltration of maxillary canine teeth: Randomized clinical trial
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Healthy adults with the age 18-55 years old; intact or with minimal caries and restoration maxillary canine teeth with normal view in periapical radiography; normal probing depth; no sensitivity to palpation and percussion; no consumption of painkillers,analgesics and anxiolytics drugs in recent 2 weeks; no allergy to anesthetic material and no medical history; clinical diagnosis of intact tooth would be confirmed by response to electric pulp tester(PARKELL,PT-20,made in USA) and normal response(short momentary answer). Exclusion criteria:Systemic disease and/or maxillary sinusitis; patients with tooth pain at the time of study; unstable heart disease; allergy to anesthesia material of lidocaine 2% with 1/80000 epinephrine or latex or lidocaine or prilocaine gels; facial or or oral parasthesia; consumption of painkillers,analgesics and anxiolytics drugs in 2 weeks before treatment; presence of periapical radiolucency; pregnancy; breast-feeding; non-repairable tooth and presence of crown
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
140
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 Tabriz University of Medical Sciences
Street address
Daneshgah Avenue, Tabriz University of Medical Sciences, Tabriz
City
Tabriz
Postal code
Approval date
2015-10-18, 1394/07/26
Ethics committee reference number
TBZMED.REC.1394.600, letter number:5/4/7721
Health conditions studied
1
Description of health condition studied
local anesthesia
ICD-10 code
XXII
ICD-10 code description
Codes for special purposes
Primary outcomes
1
Description
pain intensity
Timepoint
immediately after injection
Method of measurement
visual analoge scale
Secondary outcomes
1
Description
Hematoma
Timepoint
24 hours after treatment
Method of measurement
visual observation(objective)
Intervention groups
1
Description
This is a split mouth, randomized clinical trial study. Intervention group 1: Before administration of anesthesia, finger pressure would be applied on the alveolar mucosa at injection site in one side.
Category
Treatment - Drugs
2
Description
In the opposite side of intervention group 1, finger pressure will be applied on the tooth crown.
Category
Placebo
3
Description
Intervention group 2: Before administration of anesthesia, 5% EMLA cream would be applied on the injection site(experimental side).
Category
Treatment - Drugs
4
Description
In the opposite side of intervention group 2, placebo will be applied at the injection site.
Category
Placebo
5
Description
Intervention group3: Before administration of anesthesia, finger pressure would be applied on the alveolar mucosa at injection site on one side and on the opposite side 5% EMLA cream would be used.
Category
Treatment - Drugs
6
Description
Intervention group 4: Before administration of anesthesia, 5% EMLA cream would be applied on the injection site and on the opposite side 20% benzocaine gel would be used.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Operative Dentistry of Dental faculty
Full name of responsible person
Dr.Mehdi Daneshpooy, Assistant Professor, Operative Dentistry specialist
Street address
Second floor, Entry 3, Dental Faculty, Daneshgah Avenue, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dental and Periodontal Research Center
Full name of responsible person
Dr.shahriar Shahi
Street address
Second floor, Entry number 2, Tabriz dental faculty, Daneshgah Avenue, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental and Periodontal Research Center
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
Department of Endodontics, Faculty of Dentistry
Full name of responsible person
Amir Ardalan Abdollahi
Position
Postgraduate student of Endodontics, Dentist
Other areas of specialty/work
Street address
Second floor, Entry 3, Dental Faculty, Daneshgah Avenue, Tabriz