Protocol summary

Study aim
Evaluation of the effects of Echium amoenum tea on pain control after clinical crown lengthening surgery
Design
A clinical trial will with a placebo group, with parallel groups, two-blind, randomized. A randomized sampling from among individuals referring to the periodontology department of Tabriz Dental School. Types of treatment with code A (Echium Amoenum Tea) and B (placebo) are marked and placed in a bag. Then it was accidentally select from the bag and after the code is seen, the treatment will be given to the patient. Sample size will consist of 50 people.
Settings and conduct
The intervention group 24 hours before surgery every 12 hours, once and one hour before the start of surgery, will use a dose of Echium Amoenum Tea. The placebo group will use water as a placebo. The amount of pain will measure 30 minutes, 1, 3, 24, 48 and 72 hours after surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having conscious awareness, Patients who are candidates for surgery can increase the length of the crown of the tooth, Ages from 20 to 65 years old, Patients with moderate to severe periodontitis at the same depth of the envelope Exit criteria:Patients with systemic or mental illness, Alcoholism or any psychoactive substance, Sensitization known to be NSAID, caffeine or acetaminophen, Having any bleeding disorder, Patients at risk for any post-surgical infection, Patients with liver problems, Patients with a heart and blood pressure problems, Patients who need to increase the dose of sedative or injectable forms of sedative
Intervention groups
The intervention group 24 hours before surgery every 12 hours, once and one hour before the start of surgery, will use a dose of Echium Amoenum Tea. The placebo group will use water as a placebo.
Main outcome variables
The amount of pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180630040290N3
Registration date: 2019-07-30, 1398/05/08
Registration timing: registered_while_recruiting

Last update: 2019-07-30, 1398/05/08
Update count: 0
Registration date
2019-07-30, 1398/05/08
Registrant information
Name
Amir Reza Babaloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3428 3025
Email address
babalooa@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-11, 1398/04/20
Expected recruitment end date
2019-08-01, 1398/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the Effects of Echium Amoenum Tea on Pain Control after Clinical Crown lengthening Surgery
Public title
Evaluation the Effects of Echium Amoenum Tea on Pain Control after Clinical Crown lengthening Surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having conscious awareness Patients who are candidates for surgery can increase the length of the crown of the tooth (in the posterior maxilla). ages from 20 to 65 years old Patients who are physically and mentally healthy Patients with moderate to severe periodontitis at the same depth of envelope
Exclusion criteria:
Patients with systemic or mental illness Alcoholism or any psychoactive substance Sensitization known to be NSAID, caffeine or acetaminophen Having any bleeding disorder Patients at risk for any post-surgical infection Patients with liver problems Patients with a heart and blood pressure problems Persons with mental and physical disabilities (persons who do not have the competence to satisfy their personal satisfaction and complete the questionnaires) Patients who use of Echium Amoenum Tea are risky for them Patients who need to increase the dose of sedative or injectable forms of sedative Patients with no needs for bone surgery
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling Method is randomly among Individuals referring to the Periodontics Department of Tabriz Dental faculty. The randomization Method is simple and the unit is individual, our tool for randomization is the randomized Number Chart. Furthermore, the Allocation of Echium Amoenum tea or placebo to patients is done randomly. To do this, the types of treatments are identified with code A (Echium Amoenum tea) and B (placebo) and then they will be placed in a Box and stirred. Then they are randomly chosen from the Box and after observing the code, the treatment is given to the Patient. None of the Patients will be informed about another Patient's treatment.
Blinding (investigator's opinion)
Double blinded
Blinding description
Present Study is conducted in double-blinded fashion. Both Echium Amoenum tea and placebo will be in similar envelopes ( the same shape, size and color ).Sampling Method is randomly among Individuals referring to the Periodontics Department of Tabriz Dental faculty. The randomization Method is simple and the unit is individual, our tool for randomization is the randomized Number Chart. Furthermore, the Allocation of Echium Amoenum tea or placebo to patients is done randomly. To do this, the types of treatments are identified with code A (Echium Amoenum tea) and B (placebo) and then they will be placed in a Box and stirred. Then they are randomly chosen from the Box and after observing the code, the treatment is given to the Patient. None of the Patients will be informed about another Patient's treatment.The placebo group is treated in the same way as the intervention group, but instead of the Echium Amoenum tea, they will use ordinary water as a placebo. Contributors are unaware of the many types of treatment in the study and they are not aware of the other participants. The evaluator is also unaware of the type of treatment.
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
Central office of Tabriz University of Medical Sciences, Golgasht Ave, Azadi Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5165687386
Approval date
2019-07-01, 1398/04/10
Ethics committee reference number
IR.TBZMED.REC.1398.373

Health conditions studied

1

Description of health condition studied
Decrease the crown length of the tooth
ICD-10 code
K08.1
ICD-10 code description
Loss of teeth due to accident, extraction or local periodontal disease

Primary outcomes

1

Description
Extent of pain in the operated part
Timepoint
َAfter 30 minutes, 1 and 3 hours after the operation , 1 and 2 and 3 days after the operation
Method of measurement
En 30 minutes, 1 and 3 hours after the operation by VAS(Visual Analogue Scale) , after 1 and 2 and 3 days by VRS(Verbal Rating Scale)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group 24 hours before surgery every 12 hours once , and one hour before the start of surgery, will use a dose of Echium Amoenum Tea.
Category
Treatment - Drugs

2

Description
Control group: The placebo group 24 hours before surgery every 12 hours once , and one hour before the start of surgery, will use water as placebo.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences Dentistry Faculty Periodontics Department
Full name of responsible person
Amirreza Babaloo
Street address
Dentistry Faculty of Tabriz, Golgasht Ave, Azadi Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5921
Email
amirrezababaloo@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Central office No. 2, Tabriz University of Medical Sciences, Golgasht Ave, Azadi Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7310
Email
ajouyban@hotmail.com
Web page address
https://researchvice.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Amir reza Babaloo
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dentistry faculty, Tabriz University of Medical Sciences, Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5921
Email
amirezababaloo@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Amir reza Babaloo
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dentistry faculty, Tabriz University of Medical Sciences, Golgasht Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5921
Email
amirezababaloo@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Amir reza Babaloo
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dentistry faculty, Tabriz University of Medical Sciences, Golgasht Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5921
Email
amirezababaloo@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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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