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Effect of Berberine mouthwash on pain caused by elastomeric Seprator placement

Protocol summary

Study aim
Effect of Berberine mouthwash on pain caused by elastomeric Separator insertion
Design
This clinical trials study was conducted in parallel, randomized, and double blind groups of 60 patients. Study phase is 3 . Participants will be divided into two equal groups using random numbers: A (intervention group) and B (control group). In group A, patients will receive Berberine and will receive placebo in group B.
Settings and conduct
This study will be carried out at the dental faculty of Ahvaz University. The number of participants is 60. Patients and researcher do not know who in what group is . Mouthwashes will be provided in the same glasses by the Drug Center. To the intervention and control groups, Berberine and placebo will be given. Patients' pain is recorded using the VAS scale on days 2, 1, 5 and 7.
Participants/Inclusion and exclusion criteria
Entry Criteria: People aged between 18 and 35 years old, people with no specific systemic disease, people with no pain in other teeth or other parts of the oral cavity, selected teeth are vital without endodontic and periodontal problems, tight contact of the first permanent molar With adjacent teeth, the presence of teeth in front of the first permanent molar teeth in the opposite jaw, absence of space in the jaw. Exit criteria: use of any drug during the study, falling of separator, failure to complete the questionnaire, inappropriate use of mouthwash, history of allergy
Intervention groups
"Intervention group": The volunteers in this group will be given the Berberine mouthwash . "Control group":They will receive the Placebo.Participants in both groups should use mouthwashes for 3 days, 3 times a day, at 10 cc for 1 minute.
Main outcome variables
Pain scale based on Visual Analogue Scale

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181115041667N1
Registration date: 2019-06-08, 1398/03/18
Registration timing: registered_while_recruiting

Last update: 2019-06-08, 1398/03/18
Update count: 0
Registration date
2019-06-08, 1398/03/18
Registrant information
Name
Sayedeh Zeinab Eftekhari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8383
Email address
eftekhari-z@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-04, 1398/03/14
Expected recruitment end date
2019-07-05, 1398/04/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Berberine mouthwash on pain caused by elastomeric Seprator placement
Public title
Effect of Berberine mouthwash on pain caused by orthodontic treatments
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The samples are in the age range of 18-35, who can execute the study carefully and sign the consent form voluntarily The samples lack any specific systemic disease (such as gastrointestinal and coagulation diseases, etc.) The selected teeth are vital and have no endodontic problems The selected teeth have no periodontic problems The sample doesn't mention any pain in other teeth or other parts of the oral cavity The contact of the first permanent molar with its adjacent teeth is tight so that the banding of the first permanent molar in the beginning of the treatment requires two-way separating ( is checked using dental floss) Lack of space in the desired jaw There is a tooth in front of first permanent molar in front jaw
Exclusion criteria:
Taking any medication during the study Separator loss Not completing the questionnaire Improper use of mouthwash History of allergy to Berberine Pregnancy or breastfeeding
Age
From 18 years old to 35 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study the randomization will be done using random numbers table. After consultation with the statistics specialist even numbers will be considered for the intervention group and odd numbers for control group. The researcher stays on one of the numbers then the right direction which predefined to move and the numbers will be registered.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and researcher will not be aware of the type of herbal mouthwash. The first Berberine will be prepared in the Ahvaz Jundishapur University Of Medical Sciences. Then the phrmacist will place the Berberin and Placebo in the same glasses. Only the pharmacist will be aware of the type of content inside glasses
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz jundishapur University of Medical Sciences
Street address
Assistance of Research and Technology Development of Ahvaz Jundishapur University of Medical Sciences , Academic Town, Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-06-02, 1397/03/12
Ethics committee reference number
IR.AJUMS.REC.1397.186

Health conditions studied

1

Description of health condition studied
The pain caused by the separator placement
ICD-10 code
R52.1
ICD-10 code description
Chronic intractable pain

Primary outcomes

1

Description
Pain scale based on Visual Analogue Scale
Timepoint
Immediately after separator placement, 2 hours later and 6 hours later on the first day, at 10 am and 6 am on the second and third days, at 10 am on the seventh day
Method of measurement
Description of the patient's pain based on the Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: They must use the Berberine mouthwash(prepared in the Ahvaz Jundishapur University Of Medical Sciences) for 3 days, threewice a day, each time 10 CC for 1 minutes.
Category
Prevention

2

Description
Control group: They must use placebo for 3 days, threewice a day, each time 10 CC for 1 minutes.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Jundi Shapur University Of Medical Sciences School Of Dental Medicine
Full name of responsible person
Dr Seyede Zeynab Eftekhari
Street address
Jundi Shapur University Of Medical Sciences, Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3320 5169
Email
Eftekhari_283@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Mohammad Badavi
Street address
University of Ahvaz, Assistant Professor of Research and Technology, University of Medical Sciences Ahvaz Jundishapur Health Services - Ground floor
City
Ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3336 2414
Fax
+98 61 3336 1544
Email
badavi-m@ajums.ac.ir
Web page address
http://www.vchresearch.ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
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
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Seyede Zeynab Eftekhari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Jundi Shapur University Of Medical Sciences, Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3320 5319
Email
eftekhari-z@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Seyede Zeynab Eftekhari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of dentistry, Ahvaz Joundishapour University of medical science, Academic Town, Golestan St.
City
ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3320 5319
Email
eftekhari-z@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Seyede Zeynab Eftekhari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Jundi Shapur University Of Medical Sciences, Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3320 5319
Email
eftekhari-z@ajums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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