Main Aim
Determining amount of pain and complications due to injection of 2 brands of Botulinom Toxin type A diluted with lidocaine or normal saline of patients in Buali hospital in 1399
Specific Aims
Design
Clinical trail with control group, with parallel groups, double blinded, randomized, phase 3 on 64 patients, Exel’s random function used for randomization
Settings and conduct
Reseach will be done Clinical Trial, Double Blinded method on 64 patientsParticipants are randomly assigned to three different groups A, B and C
In each group there is one sample with a specific code and patients are selected using Exel software’s random selection.
Coded syringes will be handed to the operator who is a specific person in each group
The operator will perform the injection on 20 spots without knowing the injection material, dilution material and related codes and fill out form
The questionnaires will be sorted by codes and patients will not know about the injection material
Patient will rate their pain according to VAS scale
Patient will rate their pair according to VAS scale wherein highest tolerable pain is rated 10
Possible complications which are Ptosis, Asymmetry and Diplopia will be examined in patient next visit after 2 weeks
Participants/Inclusion and exclusion criteria
All participants without Systemic Disease who have expressed their written approval, haven’t experienced previous unpleasant injection and are not allergic to Botolinum Toxin
Intervention groups
Group A: patients who received Dysport diluted with Normal Saline
Group B: patients who received Dysport diluted with lidocaine
Group C: patients who received Xeomin diluted with Normal Saline
Main outcome variables
Pain; Ptosis; Asymmetry; Diplopia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210401050804N1
Registration date:2021-04-26, 1400/02/06
Registration timing:registered_while_recruiting
Last update:2021-04-26, 1400/02/06
Update count:0
Registration date
2021-04-26, 1400/02/06
Registrant information
Name
diba bagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2212 1467
Email address
diba.bgi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-25, 1400/02/05
Expected recruitment end date
2021-07-27, 1400/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Complication and Pain Comparison of 2 Brands of Botolinum Toxin A, Diluted with Lidocaine vs Normal Saline
Public title
Complication and Pain Comparison of 2 Brands of Botolinum Toxin A, Diluted with Lidocaine vs Normal Saline
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients without any Systemic disease
Exclusion criteria:
Patients who have experienced unpleasant injection will be eliminated from the study
Patients who are allergic to Botulinum Toxin
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are randomly assigned to three different groups A, B and C
In each group there is one sample with a specific code and patients are selected using Exel software’s random selection
(Thus each patient entering the study will be coded and assigned to one the groups A, B and C by Exel)
Blinding (investigator's opinion)
Double blinded
Blinding description
Coded syringes will be handed to the operator who is a specific person in each group
The operator will perform the injection without knowing the injection material, dilution material and related codes and fill out form
The questionnaires will be sorted by coeds and patients will not know about the injection material
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University Tehran Medical sciences faculty of Dentistry
Street address
No. 4, 10th Neyestan Ave., Pasdaran St., Tehran
City
Tehran
Province
Tehran
Postal code
19585/175
Approval date
2021-03-07, 1399/12/17
Ethics committee reference number
IR.IAU.DENTAL.REC.1399.301
Health conditions studied
1
Description of health condition studied
Facial aging
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
Pain during injection
Method of measurement
Patient will rate their pain according to Visual Analogue Scale wherein highest tolerable pain is rated 10 (0 to 3 means mild pain; 4 to 6 is considered moderate pain; 7 to 10 is severe pain)
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Group A: 100 mg Botolinum Toxin manufactured by Ipsen sold under the trade name Dysport, mixed with 1 ml Normal Saline without preservative
Category
Prevention
2
Description
Intervention group No. 1: Group B; 100 mg Botolinum Toxin manufactured by Ipsen sold under the trade name Dysport, mixed with 1 ml Lidocaine 2%
Category
Prevention
3
Description
Intervention group No. 2: Group C; 100 mg Botolinum Toxin manufactured by Merz sold under the trade name Xeomin, mixed with 1 ml Normal Saline without preservative
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
BooAli hospital
Full name of responsible person
Farzin Sarkarat
Street address
Damavand Ave, Emam Hosein Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
17117
Phone
+98 21 3334 8036
Fax
+98 21 3378 6182
Email
booali.hospital96@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Arash Azizi
Street address
No. 4, 10th Neyestan Ave., Pasdaran St., Tehran
City
Tehran
Province
Tehran
Postal code
19585/175
Phone
+98 21 2256 4571
Email
drarashazizi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Diba Bagheri
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 29, West Bidar St., Kooye Faraz St., Saadat Abad St., Tehran
City
Tehran
Province
Tehran
Postal code
1981957134
Phone
+98 21 2212 1467
Email
diba.bgi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Diba Bagheri
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 29, West Bidar St., Kooye Faraz St., Saadat Abad St., Tehran
City
Tehran
Province
Tehran
Postal code
1981957134
Phone
+98 21 2212 1467
Email
diba.bgi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Diba Bagheri
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 29, West Bidar St., Kooye Faraz St., Saadat Abad St., Tehran
City
Tehran
Province
Tehran
Postal code
1981957134
Phone
+98 21 2212 1467
Email
diba.bgi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be available to share after the participants are unrecognizable
When the data will become available and for how long
Access will be granted 6 months after results get published
To whom data/document is available
University and scientific organization’s researchers
Under which criteria data/document could be used
For future research
From where data/document is obtainable
Cranio MaxilloFacial Research Center of Islamic Azad University of Tehran - Dental branch
What processes are involved for a request to access data/document
Mailing Cranio MaxilloFacial Research Center of Islamic Azad University of Tehran - Dental branch