Evaluation of the Effect of an Innovative Combination Solution Containing: Amoxicillin, Betamethasone and Ibuprofen on Controlling pain, Swelling and Infection Caused by Wisdom Tooth Surgery
Evaluation of the Effect of an Innovative Combination Solution Containing: Amoxicillin, Betamethasone and Ibuprofen on Controlling pain, Swelling and Infection Caused by Wisdom Tooth Surgery
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 40 patients.
Settings and conduct
A total of 40 patients who comply with the inclusion criteria are admitted with the patient's consent.
First, it is randomly selected which side of each patient's face should be operated on first. Then, by simple random method, it is determined in which side, as a control group, the foam gel alone and on the opposite side, the foam gel saturated with a compound containing amoxicillin, betamethasone and ibuprofen, which is combined and is in the form of a gel, is kept silent. The data should be sutured immediately to keep the jellum still in place.
Both the patient and the researcher are blind to the study.
Participants/Inclusion and exclusion criteria
Has erupted wisdom teeth
Absence of systemic disease
Proper oral hygiene
Intervention groups
Placing amoxicillin, betamethasone and ibuprofen-saturated gelfum in the wisdom tooth
Main outcome variables
the pain
Inflammation
Infection
impurity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210818052227N1
Registration date:2021-10-26, 1400/08/04
Registration timing:registered_while_recruiting
Last update:2021-10-26, 1400/08/04
Update count:0
Registration date
2021-10-26, 1400/08/04
Registrant information
Name
pouya mansourian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3522 5936
Email address
mansourian77pouya@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-07-23, 1401/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of an Innovative Combination Solution Containing: Amoxicillin, Betamethasone and Ibuprofen on Controlling pain, Swelling and Infection Caused by Wisdom Tooth Surgery
Public title
Evaluation of the Effect of an Innovative Combination Solution Containing: Amoxicillin, Betamethasone and Ibuprofen on Controlling pain, Swelling and Infection Caused by Wisdom Tooth Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Has erupted wisdom teeth
Absence of systemic disease
Proper oral hygiene
Exclusion criteria:
systemic disease
Improper oral hygiene
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, both interventions are performed in all patients. All 40 patients are given numbers from 1 to 40. In the first step, using a simple random method using a random number table, we identify 20 patients whose first surgery is on the left and another 20 patients whose first surgery is on the right. In the second stage, for 20 patients whose first surgery is on the left, using a simple random method, using a table of random numbers, we determine which 10 patients have the first surgery of a gel saturated with a combination of amoxicillin, betamethasone and ibuprofen. Which other 10 people use foam gel alone (control group). We repeat this for 20 people whose first surgery is on the right side.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both the patient and the researcher are blind to the study. In this way, the patient and the researcher are blind to the saturation or non-saturation of the gelfum with the innovative compound. An unsaturated gelfum is placed on one side of the mouth at the site of the extracted tooth, and the saturated gelfum is placed in place of the opposite tooth in the same extracted jaw and sutured, and the results are measured by me.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Semnan University of Medical Sciences
Street address
17 shahrivar bvld ; dental univesity
City
semnan
Province
Semnan
Postal code
3518794431
Approval date
2021-10-04, 1400/07/12
Ethics committee reference number
IR.SEMUMS.REC.1400.158
Health conditions studied
1
Description of health condition studied
Extraction of wisdom teeth
ICD-10 code
K01
ICD-10 code description
Embedded and impacted teeth
Primary outcomes
1
Description
Reducing pain
Timepoint
Patients are told to report the problem in case of severe pain and discomfort. The VAS form is given to patients to record the amount of pain: 12 and 24 hours after surgery and on 2-3-4-5-6-7 days after surgery.
Method of measurement
Through the VAS chart
2
Description
Inflammation control
Timepoint
The same amount of swelling is measured 42 hours after surgery and on the morning of the 3rd and 7th days after surgery
Method of measurement
Facial width is calculated by marking 5 pink spaces on a piece of yarn and then measuring it with a ruler. Horizontal distance: The distance between the corner of the lip to the junction of the auricular lobule (Earlobe) on the same side and the piece of thread follow the convexity of the cheek. Vertical: The distance between the outer canthus of the eye to the mandibular angle of the same side and the piece of thread follow the convexity of the face. Mile: The distance from the corner of the lip to the angle of the mandible on the same side and the piece of floss should follow the possible convexity of the face (swelling after surgery). During these three measurements, the patient lies supine on the unit and the receiver is on the desired side.
3
Description
infection control
Timepoint
In terms of pus, heat and redness in the desired area
Method of measurement
Zero and one technique (zero: no infection and one: infection)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Inserting gelfoam containing amoxicillin, betamethasone and ibuprofen into the silent tooth. Turn until it is impregnated with jelfum to have a longer effect and slower absorption. The patient's tooth is extracted, the saturated gelfum is placed, then two weeks later the opposite tooth is extracted, and the simple unsaturated gelfum is placed as a control, and the results are measured and evaluated.
Category
Treatment - Drugs
2
Description
Control group: Control group: placing unsaturated gelfum inside the extract of the extracted tooth
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Semnan dental university
Full name of responsible person
Atena Afzalimehr
Street address
17 Shahrivar bvld ; Dental university
City
Semnan
Province
Semnan
Postal code
3518794431
Phone
+98 23 3333 1729
Email
dent@semums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ava Nikbin
Street address
17 Shahrivar bvld ; Dental university
City
Semnan
Province
Semnan
Postal code
3518794431
Phone
+98 23 3333 4657
Email
dent@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Pouya Mansourian
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
17Sharivar blvd - Bahar Street
City
Semnan
Province
Semnan
Postal code
3518794431
Phone
+98 23 3522 5936
Fax
Email
mansourian77pouya@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Pouya Mansourian
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
17 sharivar blvd - bahar street
City
Semnan
Province
Semnan
Postal code
3518794431
Phone
+98 23 3522 5936
Fax
Email
mansourian77pouya@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Pouya Mansourian
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
17 sharivar blvd - bahar street
City
Semnan
Province
Semnan
Postal code
3518794431
Phone
+98 23 3522 5936
Fax
Email
mansourian77pouya@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Evaluation of the Effect of an Innovative Combination Solution Containing: Amoxicillin, Betamethasone and Ibuprofen on Controlling pain, Swelling and Infection Caused by Wisdom Tooth Surgery
When the data will become available and for how long
unlimited
To whom data/document is available
unlimited
Under which criteria data/document could be used
unlimited
From where data/document is obtainable
mansourian77pouya@gmail.com
What processes are involved for a request to access data/document