Comparison of the effect of two drugs bromelain and ibuprofen in combination with acetaminophen and corticosteroid on pain and trismus after mandibular third molar surgery
The aim is to replace ibuprofen with a herbal compound with fewer side effects for pain relief in patients after wisdom teeth surgery
Design
Clinical trial with a control group, with parallel groups, double-blind, phase 1-2 on 80 patients. Stratification by simple randomization method using a sealed envelope will contain one bead (white bead of the intervention group, red bead of the control group).
Settings and conduct
Patients in need of mandibular third molar tooth surgery will be operated by a surgeon at Imam Reza Clinic (AS) in Shiraz. After surgery, patients are divided into two groups (intervention and control) by simple random allocation method. Medicines along with prescription instructions will be provided to patients. Patients receive the medicine in sealed envelopes with black cover that are coded (A and B). After starting the treatment, on days 1, 3 and 7, the pain level and degree of trismus of the patients are measured and recorded in a checklist. The study will be double-blind. Neither the patients nor the researcher will be aware of the type of drug given to the patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria include the need for mandibular third molar surgery, age between 17-35 years, and semi-occluded mesiangular mandibular third molar teeth.
Patients who have taken painkillers or other drugs before surgery, have a history of drug addiction or are allergic to the drugs used in the study will not be included in the study.
Intervention groups
Intervention group: Bromelain will be given along with acetaminophen and corticosteroid after surgery
Control group: After the surgery, ibuprofen along with acetaminophen and corticosteroids will be given
Main outcome variables
Main outcome variables of pain and trismus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230131057290N1
Registration date:2023-08-14, 1402/05/23
Registration timing:prospective
Last update:2023-08-14, 1402/05/23
Update count:0
Registration date
2023-08-14, 1402/05/23
Registrant information
Name
Ali Kochi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3336 7545
Email address
aliahmadiden@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of two drugs bromelain and ibuprofen in combination with acetaminophen and corticosteroid on pain and trismus after mandibular third molar surgery
Public title
Comparison of the effect of bromoline drug on pain and trismus after dental surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Needing mandibular third molar surgery
Age between 17-35 years
Semi-embedded mesiangular mandibular third molar teeth
Exclusion criteria:
Patients who have taken painkillers or other drugs within 24 hours before surgery.
have a history of addiction to drugs or painkillers
Patients who are pregnant or breastfeeding, or have a known sensitivity to analgesics, common non-steroidal anti-inflammatories or cyclooxygenase-2 inhibitors.
Those who have a history of nasal polyps, bronchospasm or angioedema caused by non-steroidal anti-inflammatories.
Patients who were not able to take medicine orally
Age
From 17 years old to 35 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomize in this study, simple randomization method will be used. Randomization will be done using a sealed envelope containing a bead. If there is a white bead in the envelope, the patient will be in the intervention group, and if the envelope contains a red bead, he will be placed in the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be a double-blind study. The evaluated drugs are placed in the same packages and will be provided to the patients along with the prescription instructions. Patients receive the medicine in sealed envelopes with black cover that are coded (A and B). Study drugs are administered to patients by an independent surgeon. Therefore, neither the patients nor the researchers will be aware of the type of drug given to the patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Zand St., Central Building of Shiraz University of Medical Sciences
City
shiraz
Province
Fars
Postal code
7134814336
Approval date
2023-07-05, 1402/04/14
Ethics committee reference number
IR.SUMS.DENTAL.REC.1402.040
Health conditions studied
1
Description of health condition studied
.
ICD-10 code
.
ICD-10 code description
.
Primary outcomes
1
Description
pain
Timepoint
1, 3 and 7 days after surgery
Method of measurement
A visual analogue scale (VAS), with 10 points, will be evaluated from 0 for "no pain" to 10 for "worst possible pain".
2
Description
Trismus
Timepoint
1, 3 and 7 days after surgery
Method of measurement
The degree of trismus is also measured by measuring the inter-incisal distance using a measuring caliper and the results are reported with an accuracy of 0.01 mm.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 500 mg bromelain drug (Permon Amin Pharmaceutical Company) along with acetaminophen 325 mg every 8 hours (three times a day) and corticosteroids including dexamethasone 8 mg by intramuscular injection in one session immediately after surgery.
Category
Treatment - Drugs
2
Description
Control group: Ibuprofen drug 200 mg (Hakim Pharmaceutical Company) along with acetaminophen 325 mg every 8 hours (three times a day) and corticosteroid including dexamethasone 8 mg as intramuscular injection in one time immediately after surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Clinic in Shiraz
Full name of responsible person
Ilnaz Ghanbari
Street address
Prayer Square - Imam Reza Clinic
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 3211 2700
Email
ilnazaghanbari@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Research assistant
Street address
Zand St., Central Building of Shiraz University of Medical Sciences
City
shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
hashempurm@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Ilnaz Ghanbari
Position
Assistant Professor of Oral and Maxillofacial Surgery
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Qomabad St. Qasrdasht - School of Dentistry
City
shiraz
Province
Fars
Postal code
1587871956
Phone
+98 71 3628 0112
Email
ilnazaghanbari@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ilnaz Ghanbari
Position
Assistant Professor of Oral and Maxillofacial Surgery
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Qomabad Qasrdasht St. - School of Dentistry
City
shiraz
Province
Fars
Postal code
1587871956
Phone
+98 71 3628 0112
Email
ilnazaghanbari@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ilnaz Ghanbari
Position
Assistant Professor of Oral and Maxillofacial Surgery
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Qomabad Qasrdasht St. - School of Dentistry
City
shiraz
Province
Fars
Postal code
1587871956
Phone
+98 71 3628 0112
Email
ilnazaghanbari@sums.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
The data will remain confidential with the researcher and will only be used to carry out this research project.