Protocol summary

Study aim
This study aimed to evaluate the effect of Echium Amoenum tea before dental implant surgery on pre-surgical anxiety control and post-surgical pain control.
Design
Fifty-four patients who needed dental implantation were chosen via simple randomization and categorized in two groups of equal size.
Settings and conduct
Both Echium Amoenum tea and placebo will be in similar packets (shape, size, color were similar), which is made by the Faculty of Pharmacy of Tabriz University of Medical Sciences.
Participants/Inclusion and exclusion criteria
This study included the patients in the 25-50 age bracket who needed dental implantation; Patients with systemic or mental diseases, The patients for whom the intake of Echium Amoenum tea was harmful, and the patients with psychological and stress conditions, were excluded from this study.
Intervention groups
In the intervention group, Echium Amoenum tea (made at Faculty of Pharmacy of Tabriz University of Medical Sciences) was given to the patients 1 hour before implantation, and the morning following the implantation, the patients were asked to drink it again. Placebo (drinking water whose chemical neutrality was approved by Faculty of Pharmacy of Tabriz University of Medical Sciences) was given to the control group 1 hour before the start of implantation, and the morning following the implantation, they were asked to drink the placebo again. In both groups, patients filled in the manifest anxiety questionnaire just before the start of implantation. After the implantation, both groups will take the painkiller (600 mg of Ibuprofen, every 6 hours, for three days) according to the surgeon’s order.
Main outcome variables
Extent of pain in the operated part after 30 minutes, 1 and 3 hours, 1 and 2 and 3 days after the operation. Preoperative anxiety.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180630040290N1
Registration date: 2018-07-15, 1397/04/24
Registration timing: prospective

Last update: 2018-07-15, 1397/04/24
Update count: 0
Registration date
2018-07-15, 1397/04/24
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
2018-09-22, 1397/06/31
Expected recruitment end date
2019-03-19, 1397/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of Evaluation of The Effect of Echium Amoenum Tea before Dental Implant surgery on Pre-surgical Anxiety Control and Post-surgical Pain Control
Public title
Evaluation of The Effect of Echium Amoenum Tea before Dental Implant surgery on Pre-surgical Anxiety Control and Post-surgical Pain Control
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The patients in the 25-50 age bracket. The patients who needed dental implantation.
Exclusion criteria:
Patients with systemic or mental diseases. Patients with hemorrhagic, lever, cardiac and hypertension diseases. Pregnant and breastfeeding women. The patients for whom the intake of Echium Amoenum tea is harmful. The patients with psychological and stress conditions.
Age
From 25 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Both Echium Amoenum tea and placebo will be in similar packets (shape, size, color were similar), which is made by the Faculty of Pharmacy of Tabriz University of Medical Sciences.
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
2018-06-25, 1397/04/04
Ethics committee reference number
IR.TBZMED.REC.1397.263

Health conditions studied

1

Description of health condition studied
Effect of Echium Amoenum Tea on Pre-surgical Anxiety Control and Post-surgical Pain Control
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Preoperative anxiety
Timepoint
Just before the start of surgery
Method of measurement
Spielberger's manifest anxiety questionnaire

Secondary 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
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)

Intervention groups

1

Description
Intervention group: Echium Amoenum Tea (made at Faculty of Pharmacy of Tabriz University of Medical Sciences) was given to the patients 1 hour before implantation, and the morning following the implantation, the patients were asked to drink it again.Patients filled in the Spielberger's manifest anxiety questionnaire just before the start of implantation.
Category
Treatment - Other

2

Description
Control group: Placebo (drinking water whose chemical neutrality was approved by Faculty of Pharmacy of Tabriz University of Medical Sciences) was given to the control group 1 hour before the start of implantation, and the morning following after the implantation, they were asked to drink the placebo again.Patients filled in the Spielberger's manifest anxiety questionnaire just before the start of implantation.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental Clinic of Faculty of Dentistry of Tabriz
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
Fax
Email
amirrezababaloo@yahoo.com
Web page address
https://dentistryfac.tbzmed.ac.ir/

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
Periodontics
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 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 Esmaeilpour
Position
Student
Latest degree
A Level or less
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
dramiresmaeilpour@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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