Comparison of the effectiveness of pomegranate peel extract mouth rinse & normal saline on complications of third molar surgery in patients having third molars
Determination of effect of pomegranate peel mouth-rinse on complications of impacted mandibular third molar
Design
This study is a clinical trial with control group and parallel design including 46 cases: 23 patients having bilateral mandibular third molars. This study will be done in both sides of patients mouth , one side as intervention group and the other side as control group
Settings and conduct
The method of study will be as following: pomegranate peel extract mouth rinse will be prescribed for one side of mouth, and normal saline will be prescribed for the other side of mouth after surgery.
Participants/Inclusion and exclusion criteria
Healthy individuals in the range of 20-35 years having bilateral impacted third molars of mandible; without any systemic disease; without Temporo-Mandibular Joint (TMJ) disorder; without limitation of mouth opening; non smoker
Intervention groups
One side of mouth, as intervention group, will be rinsed with pomegranate peel extract mouthrinse after the third mandibular molar surgery.
Other side of mouth, as control group, will be rinsed with normal saline after the third mandibular molar surgery.
Main outcome variables
swelling ; incidence of dry socket ; pain ; trismus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180117038415N1
Registration date:2018-03-04, 1396/12/13
Registration timing:retrospective
Last update:2018-03-04, 1396/12/13
Update count:0
Registration date
2018-03-04, 1396/12/13
Registrant information
Name
Ali Mortazavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 5965
Email address
mortazavia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-01-02, 1395/10/13
Expected recruitment end date
2018-01-03, 1396/10/13
Actual recruitment start date
2017-01-02, 1395/10/13
Actual recruitment end date
2018-01-03, 1396/10/13
Trial completion date
empty
Scientific title
Comparison of the effectiveness of pomegranate peel extract mouth rinse & normal saline on complications of third molar surgery in patients having third molars
Public title
The effect of pomegranate peel mouth-rinse on complications of wisdom tooth surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals in the age range of 20-35 years having bilateral third molars that are similar in classification of impacted teeth
informed consent
Exclusion criteria:
Systemic disease
TMJ disorder
Limitation of mouth opening
smoking
Age
From 20 years old to 35 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
23
More than 1 sample in each individual
Number of samples in each individual:
2
Bilateral impacted third mandibular molars
Actual sample size reached:
23
More than 1 sample in each individual
Actual sample size in each individual:
2
Bilateral impacted third mandibular molars
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not 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
Vice chancellor for researchs & technology affairs, central building no 2, Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2018-01-01, 1396/10/11
Ethics committee reference number
IR.TBZMED.REC.1396.921
Health conditions studied
1
Description of health condition studied
Complications of third molar tooth surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Swelling
Timepoint
Pre-operation, day 1 post-operation, day 3 post-operation, day 7 post-operation
Method of measurement
Measuring the tragus - alar , tragus - mandible angle, mandible angle - alar distances with a string
2
Description
Incidence of dry socket
Timepoint
Observation of surgery area in day 3 post operation , day 7 post-operation
Method of measurement
Observing the surgery area and assessing the symptoms
3
Description
Pain
Timepoint
Day 1 post-operation , day 3 post-operation, day 7 post-operation
Method of measurement
Visual analog scale (asking from patient, scoring from 1 to 10)
4
Description
Trismus
Timepoint
Pre-operation , day 1 post-operation , day 3 post-operation , day 7 post-operation
Method of measurement
Measuring the maximum space between central incisors of maxilla and mandible
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: one side of patients mouth will rinse with pomegranate peel extract mouth rinse with concentration of 2.5 grams per liter for 30 seconds, 4 times a day.
Category
Treatment - Drugs
2
Description
Control group: The opposite side of patients' mouth will be rinsed with normal saline 0.9% mouthwash for 30 seconds, 4 times a day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Faculty of Dentistry
Full name of responsible person
Ali Mortazavi
Street address
Faculty of dentistry, Daneshgah street.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
mortazavia@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammadreza Rashidi
Street address
Tabriz University of Medical Sciences, Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
mortazavia@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
Ali Mortazavi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dentistry faculty , Daneshgah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
mortazavia@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Mortazavi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dentistry faculty , Daneshgah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
mortazavia@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Mortazavi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dentistry faculty , Daneshgah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
mortazavia@tbzmed.ac.ir
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