Aim: Probing is the only reliable method for the detection of periodontal disease yet is painful. EMLA anesthetic gel can be used for decreasing pain during probing.The aim of this study was to evaluate the effect of EMLA anesthetic gel on pain during Probing in patients with chronic periodontists who were referred to the Department of Periodontal,dental branch, Islamic Azad University .Method:This clinical,double-blind , Split Mouth study was performed on 20 eligible patients. All existing teeth in two quadrant were randomized assigned as anesthetic(test) or placebo(control) group and probing was done at 6 site per teeth. Pain was measured using VAS (10 cm) before and 30 second after application of gel and data was recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201409143720N4
Registration date:2015-02-28, 1393/12/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-28, 1393/12/09
Registrant information
Name
Roya Shariatmadarahmadi
Name of organization / entity
Department of periodontology, Dental branch, Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
r_shariatmadari@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-04-21, 1393/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Eutectic Mixture of Lidocaine and Prilocain ( EMLA) anesthetic gel on pain during Probing in Patients With chronic Periodontists.
Public title
A randomized double-blind placebo controlled clinical trial of the effect of Eutectic Mixture of Lidocaine and Prilocain (EMLA) anesthetic gel on pain during Probing in
Patients With chronic Periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria were: patients with chronic periodontists with PD ≥4 mm and CAL ≥3; patients needed to have a minimum of one incisors, one canine, one premolar, and one molar in two quadrants; patients with no periodontal therapy in the previous 6 months; and a signed informed consent form
exclusion criteria: those requiring prophylactic antibiotics before periodontal probing; those suffering from any psychiatric disorders or with chronic pain problems; those with coagulation disorders or on anti coagulation therapy; female patients that were pregnant or lactating; patients with congenital or idiopathic met- hemoglobinemia or those receiving treatment with methemoglobin-inducing agents; those reporting allergies to dental anesthetics; those taking non-steroidal anti-inflammatory drugs in the 3 days before participation in the study; patients having acute periodontal pain, pulpits, abscesses,or other acute infections.
Age
No age limit
Gender
Both
Phase
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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
randomisation was performed by coin.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University- dental branch
Street address
no:4 - 10th neiystan- pasdaran st.-Tehran - Iran
City
Tehran
Postal code
Approval date
2014-11-12, 1393/08/21
Ethics committee reference number
24311
Health conditions studied
1
Description of health condition studied
Periodontitis
ICD-10 code
ko5.3
ICD-10 code description
Periodontitis
Primary outcomes
1
Description
pain during probing
Timepoint
before intervetion/30-45 seconds aftherintervention
Method of measurement
Visual analog pain with ruler (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: EMLA gel 2.5% (Eutectic Mixture of Lidocain Prilocain)(Made by Pharmaceutical Laboratory of Hakim Co,Tehran- Iran .
Category
Treatment - Drugs
2
Description
"Control group":Placebo gel was prepared in the same manner but without the active drug in it(Made by Pharmaceutical Laboratory of Hakim Co,Tehran- Iran .
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University of Tehran, Dental Branch
Full name of responsible person
Dr.Roya Shariatmadarahmadi
Street address
No:4, 10th Neyestan, Pasdaran St., Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research Council of Dental Branch Islamic Azad University of Tehran
Full name of responsible person
Dr Azizi
Street address
No:4,,10th Neiystan, pasdaran St., Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research Council of Dental Branch Islamic Azad University of Tehran
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
Islamic Azad University of Tehran-Dental Branch
Full name of responsible person
Dr Roya Shariatmadarahmadi
Position
Assisstant professor
Other areas of specialty/work
Street address
No:4, 10th Nieyestan, Pasdaran St., Tehran, Iran
City
Tehran
Postal code
19585/175
Phone
+98 21225645713
Fax
Email
dr.r.shariatmadari@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of Tehran- Dental Branch
Full name of responsible person
Dr.Roya Shariatmadarahmadi
Position
periodontist
Other areas of specialty/work
Street address
No:4, 10th Neiystan, Pasdaran St., Tehran, Iran
City
Tehran
Postal code
19585/175
Phone
+98 21225645713
Fax
Email
dr.r.shariatmadari@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)