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Comparison of analgesic and anti-inflammatory effect of topical application of ginger aqueous extract with local dexamethasone injection after extraction of mandibular wisdom teeth

Protocol summary

Summary
The aim of this study was to compare the analgesic and anti-inflammatory effects of topical application of ginger aqueous extract and local dexamethasone injection after extraction of mandibular wisdom. The aim of this study was to facilitate supportive care and reduce the complications of dexamethasone and analgesics. Design of the study: Interventional, non-random, non-randomly assigned to intervention and control, with placebo, parallel intervention groups. Main criteria for entering the study: having the same wisdom teeth in the mandible and the desire to remove both, general health criteria Main outcomes: Incompatibility and sensitivity to any of the drugs used in the study. Blindness: For the patient: In the place where the ginger bioadhesive, after removing the tooth, one carpool of lidocaine anesthetic is injected as a placebo. Also, in the tooth extraction of the other side, which1.8 ml of dexamethasone 1.6 mg is injected, base bioadhesive (without ginger) is used. For researcher: After removing the tooth and using the appropriate medication and placebo by surgeon, the researchers provided the patient with post-discharge explanations. Therefore, this study was blind to the patient and researcher. In fact, only the surgeon knows what medicine he has used. The researcher and patient do not know.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017082635906N1
Registration date: 2017-09-09, 1396/06/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-09-09, 1396/06/18
Registrant information
Name
sahar zandi
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 3356 5374
Email address
s.zandi@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Invastigator
Expected recruitment start date
2017-09-06, 1396/06/15
Expected recruitment end date
2017-11-06, 1396/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of analgesic and anti-inflammatory effect of topical application of ginger aqueous extract with local dexamethasone injection after extraction of mandibular wisdom teeth
Public title
Study of analgesic and anti-inflammatory effect of ginger
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The patient has a double-walled tooth (based on the angle of tooth placement in the jaw, the amount of bone and soft tissue on the tooth, the condition of the tooth in relation to the anterior border of ramus), the willingness to cooperate And there is no prohibition of tooth surgery or sensitivity to ginger. The tooth does not have any pathological lesions in the root zone in clinical and radiographic examinations. No other surgical procedures for at least two weeks. Exclusion criteria: kidney or liver disease, bleeding problems such as hemophilia, neutropenia, blood platelet deficiency, etc., previous or current stomach ulcers, any heart disease, Known allergies, allergies, or individual reactions to either the drugs used or the drugs that may be used in the study (ginger, lidocaine anesthesia, acetaminophen codine 300, gelofen 400, amoxicillin 500, and metronidazole 400 mg G) Pregnancy and lactation, taking analgesic or anti-inflammatory drugs 24 hours before the study, having pain and other inflammatory symptoms including swelling, high blood pressure and the inability to open the mouth before the study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of the Vice-Chancellor of Research of Bushehr University of Medical Sciences
Street address
Imam Khomeini Ave (Bushehr), Bushehr University of Medical Sciences, Faculty of Dentistry
City
Bushehr
Postal code
Approval date
2016-05-14, 1395/02/25
Ethics committee reference number
IR.BPUMS.REC.1396.36

Health conditions studied

1

Description of health condition studied
Extracting the mandibular double-sided wisdom teeth
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The amount of pain
Timepoint
Day of intervention, one day after intervention, two days after intervention, three days after intervention
Method of measurement
VAS scale (number)

2

Description
Mouth opening rate
Timepoint
Pre-intervention, 24 hours after intervention, 72 hours after intervention
Method of measurement
Millimeters

3

Description
Distance between the corner of the mouth and the tragus
Timepoint
Pre-intervention, 24 hours after intervention, 72 hours after intervention
Method of measurement
Millimeters

4

Description
The amount of acetaminophen codoine 300 mg taken
Timepoint
Day of intervention, one day after intervention, two days after intervention, three days after intervention
Method of measurement
questionnaire

Secondary outcomes

1

Description
age
Timepoint
Before intervention
Method of measurement
questionnaire

2

Description
gender
Timepoint
Before intervention
Method of measurement
questionnaire

3

Description
infection
Timepoint
Before intervention, 24 hours after intervention, 72 hours after intervention
Method of measurement
View, interview

4

Description
Any other anti-inflammatory or analgesic drug
Timepoint
three days after the intervention
Method of measurement
questionnaire

Intervention groups

1

Description
In this double-blind clinical trial, anti-inflammatory and anti-inflammatory effects of topical administration of a 20% tissue bioadhesive made of 100% ginger extract and a mucosal dexamethasone injection of 1.6 mg after extraction of the wisdom teeth will be compared. The similarity of the mandibular teeth is performed by a qualified expert oral and maxillofacial radiologist through panoramic radiography images based on the indications in the radiology images and the classifications available in reference books as well as by a clinical examination by a oral and maxillofacial surgeon. The angle of tooth placement in the jaw, the amount of bone and soft tissue on the tooth, and the tooth position should be similar. Each patient will take amoxicillin 500 mg and metronidazole 400 mg 30 minutes before startingextraction. For each patient, the choice of which treatment is to be done on his right or left tooth will be done using random numbers. Patients will be injected with two carpool of lidocaine anesthetics with inferior alveolar nrve block technique, then removed by the surgeon and under the cut-off procedure of the mucoperiosteal envelope flap (in case of need for surgery) or by simple tooth extraction. Then, according to a randomized random number, in the cavity of the tooth extracted, the area of 4 cm 2 of the bioadhesive contains 20% ginger extract will be replaced or 1.8 ml of the dexamethasone dose of 1.6 mg will be injected. The degree of opening the patient's mouth (Trismus status) and the distance between the commisure of oral cavity of the patient and the tragus of his ear (checking the status of swelling) will be measured and recorded before surgery, 24 hours and 72 hours after surgery. A translated VAS pain intensity questionnaire will be provided for patients and they will determine the amount of pain in the respective hours (surgery day and one to three days after surgery). Also, in connection with taking medications, he will be allowed to use acetaminophen codoine 300 mg in case of severe pain. In addition to the numbers of the VAS scale, the number of acetaminophen codin 300 mg tablets taken will be reported to the researcher in each of the days (surgery day and one to three days after surgery). The opening of the mouth and the tragus distance to the corner of his lips, which is considered as a criterion for trismus and swelling of the position, will be measured and recorded by the researcher before surgery 24 hours and 72 hours after surgery. The patient is taking antibiotics amoxicillin 500 and metronidazole 400 every 8 hours and mouthwash (spatula twice a day) up to one week.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental Clinic, Faculty of Dentistry, Bushehr University of Medical Sciences
Full name of responsible person
Sahar Zandi
Street address
Shahid Heidari St., Imam Khomeini Avenue, Dental Clinic, Bushehr University of Medical Sciences, Bushehr, Iran.
City
Bushehr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The Vice-Chancellor of Research of Bushehr University of Medical Sciences
Full name of responsible person
Dr. Saman Jokar
Street address
Imam Khomeini Street, Bushehr University of Medical Sciences, Faculty of Dentistry
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The Vice-Chancellor of Research of Bushehr University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
School of Dentistry, Bushehr University of Medical Sciences
Full name of responsible person
Sahar Zandi
Position
Student of General Dentistry
Other areas of specialty/work
Street address
Imam Khomeini Street, Bushehr University of Medical Sciences, Faculty of Dentistry
City
Bushehr
Postal code
7514633341
Phone
+98 77 3356 5374
Fax
Email
s.zandi@bpums.ac.irsaharzandi72@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Saman jokar
Position
Assistant Professor of Maxillofacial Surgery
Other areas of specialty/work
Street address
Imam Khomeini Street, Bushehr University of Medical Sciences, Faculty of Dentistry
City
Bushehr
Postal code
7514633341
Phone
+98 77 3356 5374
Fax
Email
saman.jokar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Dentistry, Bushehr University of Medical Sciences
Full name of responsible person
Sahar Zandi
Position
Student of General Dentistry
Other areas of specialty/work
Street address
Imam Khomeini Street, Bushehr University of Medical Sciences, Faculty of Dentistry
City
Bushehr
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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