Protocol summary

Study aim
Evaluation of effectiveness of Lactuca sativa in postoperative pain control following surgical removal of impacted mandibular third molars.
Design
Clinical trial with control group, parallel groups, double blind, randomized
Settings and conduct
Effectiveness of Lactuca Sativa after mandibular third molar surgery was evaluated in terms of patient's pain. The split mouth was divided into Lactuca Sativa or placebo syrup. In this double blinded study, patients and researchers were unaware of the outcome of treatment with Lactuca Sativa or placebo. The study was conducted at the faculty of dentistry of Arak University of Medical Sciences. The pain intensity of the patients was evaluated on the first to fourth day after surgery with the VAS scale.
Participants/Inclusion and exclusion criteria
All patients with symmetrical mandibular third molars with full bone or relative bone, in the same classification (in terms of spatial orientation and position of tooth, depth of impaction and relationship with Ramus in radiography) and with same degree of surgical difficulty, painless up to day surgery, without systemic disease, and history of allergy or bleeding problems.
Intervention groups
Intervention group :Use of Lactuca Sativa after mandibular third molar surgery that will be used 3 days before surgery, 3 times a day, and each time a bowl of spoon will be consumed half an hour after the meal, and the same way, until 4 days after surgery It will continue. Control group: Use of placebo syrup after mandibular third molar surgery that will be used 3 days before surgery, 3 times a day, and each time a bowl of spoon will be consumed half an hour after the meal, and the same way, until 4 days after surgery It will continue.
Main outcome variables
Postoperative pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180828040899N2
Registration date: 2020-07-16, 1399/04/26
Registration timing: retrospective

Last update: 2020-07-16, 1399/04/26
Update count: 0
Registration date
2020-07-16, 1399/04/26
Registrant information
Name
Hadi Jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3425 4409
Email address
hadj2424der@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Lactuca Sativa in Postoperative Pain Control Following Surgical Removal of Impacted Mandibular Third Molars (Wisdom Tooth): Double Blind Randomized Clinical Trial.
Public title
Effectiveness of Lactuca Sativa in Postoperative Pain Control Following Surgical Removal of Impacted Mandibular Third Molars (Wisdom Tooth).
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with symmetrical mandibular third molars with full bone or relative bone in the same classification (in terms of spatial orientation and position of tooth, depth of impaction and relationship with Ramus in radiography) with same degree of surgical difficulty require Surgery of Impacted mandibular third molars All patients have good health painless up to day surgery
Exclusion criteria:
Patients with a previous medical history or report of systemic disease history of allergy Smokers Patients with a history of long-term use of antibiotics and corticosteroids Pregnant women
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 35
Randomization (investigator's opinion)
Randomized
Randomization description
To determine the surgical side of surgery, the number 1 for lettuce syrup and the number 2 for placebo will be considered. There are 70 envelopes of similar appearance that will be in 35 envelopes number 1 and 35 envelopes number 2, envelopes numbered from 1 to 70, and a random number table will be counted for the first surgery that the patient will be blindfolded. He puts on a number, we give the envelope to the patient while the patient does not know the number is 1 or 2 in the envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is designed double blinded, so that the participants (patients) initially did not know if the Lactuca Sativa was given or the placebo was unaware, as well as the experts reviewing the results of the two interventions for the type of intervention They are unaware of the patient. In order to achieve the goals of blindness in this study, it needs to be explained that the surgeon specializing in evaluating the results from the use of Lactuca Sativa and placebo syrup is different, and the expert assessing the results is completely unaware of the Lactuca Sativa or placebo syrup and it is someone. Which is selected from the outside of the therapeutic system.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
ScienceArak University of Medical Sciences, Basij Square, Sardasht, Khalij Fars Boulevards
City
Arak
Province
Markazi
Postal code
3848153793
Approval date
2020-02-16, 1398/11/27
Ethics committee reference number
IR.ARAKMU.REC.1398.315

Health conditions studied

1

Description of health condition studied
The patient's pain after mandibular third molars extraction surgery following consumption of Lactuca Sativa
ICD-10 code
Z00-Z99
ICD-10 code description
Factors influencing health status and contact with health services

Primary outcomes

1

Description
Pain scale based on VAS scale
Timepoint
From day one to fourth after surgery
Method of measurement
visual analog scale (VAS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group :Use of Lactuca Sativa after mandibular third molar surgery that will be used 3 days before surgery, 3 times a day, and each time a bowl of spoon will be consumed half an hour after the meal, and the same way, until 4 days after surgery It will continue.
Category
Treatment - Drugs

2

Description
Control group: Use of placebo syrup after mandibular third molar surgery that will be used 3 days before surgery, 3 times a day, and each time a bowl of spoon will be consumed half an hour after the meal, and the same way, until 4 days after surgery It will continue.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Arak Dental School
Full name of responsible person
Research committee of Arak University of Medical Science . Dr. Mohammad Arjmandzadegan
Street address
Between Andisheh 5 and 6 Alleys, Ghadir Blvd., Nabaei town, Sardasht
City
Arak
Province
Markazi
Postal code
3848153793
Phone
+98 86 3272 4522
Email
hadj2424der@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
ِDr. Mohammad Arjmandzadegan
Street address
Arak University of Medical Sciences, Basij Square, Sardasht, Khalij Fars Boulevard
City
Arak
Province
Markazi
Postal code
3848153793
Phone
+98 86 3417 3505
Email
Arjmanzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Hadi Jafari
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Between Andisheh 5 and 6 Alleys, Ghadir Blvd., Nabaei town, Sardasht
City
Arak
Province
Markazi
Postal code
3848153793
Phone
+98 86 3272 4522
Email
hadj2424der@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hadi Jafari
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Between Andisheh 5 and 6 Alleys, Ghadir Boulevard, Nabaei town
City
Arak
Province
Markazi
Postal code
3848159345
Phone
+98 86 3272 4522
Email
hadj2424der@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hadi Jafari
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Between Andisheh 5 and 6 Alleys, Ghadir Blvd., Nabaei town, Sardasht
City
Arak
Province
Markazi
Postal code
3848153793
Phone
+98 86 3272 4522
Email
hadj2424der@yahoo.com

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
After the publication of this article in a journal if the privacy of patients is not invaded information will be given to the respected center.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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