Evaluation of the effect of the green tea extract on the postoperative pain following surgical removal of the impacted mandibular third molar
Design
A double-blinded clinical trial with a parallel-group design of 32 self-controlled participants enrolled between June to August 2018.
Settings and conduct
32 participants were selected from June to August 2018 among whom referred to the Dentistry Faulty of Isfahan University of Medical Sciences. surgical extraction of the impacted mandibular third molars was performed in two months. local anesthesia was achieved and an envelope flap was made using a standard incision. after extraction of the tooth, the flap was managed by suturing with silk 3-0. based on the randomized order, saline or green tea-extract-impregnated gauze was applied to the surgical site. patients were given 10 tablets of ibuprofen 400 mg only for using only when the patient is in pain. 6, 12, 24, and 48 hours after surgery, patients were evaluated concerning the postoperative pain using VAS and the number of analgesics. this study was a double-blinded one in which none of the patient and surgeon was not aware of the exact location of the green tea-extract-impregnated gauze.
Participants/Inclusion and exclusion criteria
having bilateral impacted mandibular third molar with the same level of difficulty was considered as the inclusion criteria. any factor affecting the postoperative pain exclude the patient from the study.
Intervention groups
after the extraction of the impacted mandibular third molars in 2 months, based on the randomized order, saline or green tea-exract-impregnated gauze was applied on the surgical site.
Main outcome variables
type of the gauze applied to the surgical site; the score of the VAS for pain in 6, 12, 24, and 48 hours after surgery; the number of analgesics used in 6, 12, 24, and 48 hours after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131205015665N4
Registration date:2020-07-10, 1399/04/20
Registration timing:retrospective
Last update:2020-07-10, 1399/04/20
Update count:0
Registration date
2020-07-10, 1399/04/20
Registrant information
Name
Milad Etemadi-Shalamzari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 1391 3237
Email address
etemadi@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-08-22, 1397/05/31
Actual recruitment start date
2018-05-22, 1397/03/01
Actual recruitment end date
2018-08-11, 1397/05/20
Trial completion date
2018-08-13, 1397/05/22
Scientific title
Evaluation of the effect of green tea extract on the postoperative pain following surgical removal of the impacted mandibular third molar
Public title
Evaluation of the effect of green tea extract on the postoperative pain following surgical removal of the impacted mandibular wisdom tooth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having bilateral impacted mandibular third molar with the same difficulty based on the spatial direction of the teeth (mesioangular) on preoperative panoramic radiography
Having bilateral impacted mandibular third molar with the same difficulty based on the depth of impaction (Pell & Gregory classifications/type B) on preoperative panoramic radiography
Having bilateral impacted mandibular third molar with the same difficulty based on the relationship with the anterior border of the ramus (class 1) on preoperative panoramic radiography
Exclusion criteria:
having allergy to green tea products
being younger than 18 years old or having more than 30 years of age
receiving other drugs like antibiotics, analgesics, and herbal therapy for pain/ infection in the last 30 days
presence of any kind of lesion (benign or malignant) in the site of surgery before surgery
pregnancy and/or lactation
systemic health problems
presence or history of pain in the maxillofacial region like temporomandibular joint disorder (TMD) or myofascial pain and dysfunction syndrome (MPDS) before surgery
presence of pulpitis
drug addiction (methamphetamine, ephedrine, or cocaine)
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
32
More than 1 sample in each individual
Number of samples in each individual:
2
surgical removal of the impacted mandibular wisdom teeth will be performed with the time interval of two months. based on the patient's ID number and randomization plan, after one surgery green tea-impregnated gauze will be applied on one side and saline-impregnated gauze on the other side.
Actual sample size reached:
31
More than 1 sample in each individual
Actual sample size in each individual:
2
surgical removal of the impacted mandibular wisdom teeth was performed with the time interval of two months. based on the patient's ID number and randomization plan, after one surgery green tea-impregnated gauze was applied on one side and saline-impregnated gauze on the other side.
Randomization (investigator's opinion)
Randomized
Randomization description
pseudorandomization will be performed in this study. after considering an identification number from 1 to 32 for each patient; in patients with an odd ID number, green tea-impregnated gauze will be used on the right side and saline-impregnated gauze will be applied to the left side. in patients with an even ID number, green tea-impregnated gauze will be used on the left side and saline-impregnated gauze will be applied to the right side
Blinding (investigator's opinion)
Double blinded
Blinding description
for blinding the participants: they will not be aware of the exact location of application of the green tea-impregnated gauze after surgery
for blinding the care provider: the surgeon will not be aware of the exact location of application of the green tea-impregnated gauze after surgery and application of the gauze and patient's instruction will be performed by the researcher and in the absence of the surgeon
Placebo
Used
Assignment
Parallel
Other design features
split-mouth design
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan university of medical sciences
Street address
oral and maxillofacial surgery department, dentistry faculty, Isfahan university of medical sciences,Hezar-jerib st., Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Approval date
2018-05-15, 1397/02/25
Ethics committee reference number
IR.MUI.REC.1397.3.067
Health conditions studied
1
Description of health condition studied
evaluation of the postoperative pain following application of the green tea-impregnated gauze after surgical extraction of the impacted mandibular third molar
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
severity of the pain based on Visual analogue scale (VAS)
Timepoint
evaluation of the severity of the pain 6, 12, 24, and 48 hours after surgery
Method of measurement
using Visual analogue scale (VAS)
2
Description
number of analgesics (ibuprofen) used after surgery
Timepoint
6, 12, 24,and 48 hours after surgery
Method of measurement
asking the patient
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: All the surgeries will be performed by an experienced surgeon using the same protocol: the povidone-iodine solution will be applied to the surgical site; 2% lidocaine and 1:80,000 epinephrine (Iran, Tehran, Exir) will be used to block the inferior alveolar and long buccal nerves; a mucoperiosteal envelop flap will be created using a standard incision; if needed, bone removal, tooth sectioning, and bone recontouring will be performed with a low-speed hand-piece under sufficient sterile solution irrigation; following tooth removal the socket will be irrigated with 60 ml of saline; the flap will be sutured using 3–0 silk sutures. Green tea extract-impregnated sterile gauze will be used after removing the right or left tooth, according to the randomized order specified before and based on the patient's ID number. Both patients and surgeons will be blinded to the type of gauze. Iranian green tea will be purchased from the market (Iran, Mashhad, Zarghani company). For the preparation of hydroalcoholic extract, green tea will be powdered and 300 grams of the powder will be macerated by 1500 ml of ethanol 70% (v/v) for 72 hours. The extract will be then shaken, filtered and the solvent will be removed in a vacuum evaporator to obtain a semi-solid extract, and then it will be placed in an oven at 60°C for 72 hours. Patients will be instructed to take no painkiller or narcotics 12 hours before the procedure. As the surgery finished they will be given 10 Advalgine (Ibuprofen Lysine 400 mg) tablets and told to use them as the only medication for pain relief. They also will be instructed not to drink green tea beverages 48 hours after the operation. Respectively 6, 12, 24, and 48 hours after the end of the procedure by telephone contact, they will be asked about the presence and intensity of pain on the surgical site. On the third day after the operation, patients will be examined by the surgeon to note if they had experienced a dry socket. The decrease in the VAS pain scores as well as the number of analgesics used will be calculated for each patient.
Category
Treatment - Other
2
Description
Intervention group 2: All the surgeries will be performed by an experienced surgeon using the same protocol: the povidone-iodine solution will be applied to the surgical site; 2% lidocaine and 1:80,000 epinephrine (Iran, Tehran, Exir) will be used to block the inferior alveolar and long buccal nerves; a mucoperiosteal envelop flap will be created using a standard incision; if needed, bone removal, tooth sectioning, and bone recontouring will be performed with a low-speed hand-piece under sufficient sterile solution irrigation; following tooth removal the socket will be irrigated with 60 ml of saline; the flap will be sutured using 3–0 silk sutures. Green tea extract-impregnated sterile gauze will be used after removing the right or left tooth, according to the randomized order specified before and based on the patient's ID number. Both patients and surgeons will be blinded to the type of gauze. Patients will be instructed to take no painkiller or narcotics 12 hours before the procedure. As the surgery finished they will be given 10 Advalgine (Ibuprofen Lysine 400 mg) tablets and told to use them as the only medication for pain relief. They also will be instructed not to drink green tea beverages 48 hours after the operation. Respectively 6, 12, 24, and 48 hours after the end of the procedure by telephone contact, they will be asked about the presence and intensity of pain on the surgical site. On the third day after the operation, patients will be examined by the surgeon to note if they had experienced a dry socket. The decrease in the VAS pain scores as well as the number of analgesics used will be calculated for each patient.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan University of Medical Sciences, Dentistry Faculty
Full name of responsible person
Milad Etemadi Shalamzari
Street address
Oral and Maxillofacial surgery section, Dentistry Faculty, Isfahan University of medical Sciences, Hezar-jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5581
Fax
Email
etemadi@dnt.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Vice-chancellor in research affairs, Isfahan University of Medical Sciences, Hezar-jerib st., Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Web page address
https://research.mui.ac.ir/
Grant name
Grant code / Reference number
397067
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Milad Etemadi Shalamzari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of oral and maxillofacial surgery, dentistry faculty, Isfahan university of medical sciences, Hezar-jerib st., Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5581
Email
etemadi@dnt.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Milad Etemadi Shalamzari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of oral and maxillofacial surgery, dentistry faculty, Isfahan university of medical sciences, Hezar-jerib st., Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5581
Email
etemadi@dnt.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Milad Etemadi Shalamzari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of oral and maxillofacial surgery, dentistry faculty, Isfahan university of medical sciences, Hezar-jerib st., Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5581
Email
etemadi@dnt.mui.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
there is no further information
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
study protocol
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
available for whom working in academic institutions
Under which criteria data/document could be used
no other condition
From where data/document is obtainable
sending request email to "gtajmiri.gt@gmail.com"
What processes are involved for a request to access data/document
10 days after the request, data will be accessible