1. Home
  2. Approved trials
  3. » فارسی

The Effect of Bromelain on Pain, Swelling and Trismus after Surgery in Orthognathic Patients

Protocol summary

Study aim
The effect of bromelain on pain, swelling and trismus after surgery in orthognathic patients
Design
Clinical trial with a control group, with parallel groups, three blinded, randomized, phase 3 on 20 patients. For randomization, the computer software will be "Random Allocation Software".
Settings and conduct
therapeutic goal; in Mashhad Dental Faculty and Mother Hospital; Patients are divided into two groups of 10. After surgery, both groups of patients will be given 8 mg dexamethasone every 8 hours for three days, cefazolin 1 mg every 6 hours for three days, and Apotel every 6 hours for 3 days, in addition to the intervention group Bromelain 200 mg daily and placebo (capsules containing lactose) will be given to the control group in 3 meals for up to 8 days. Study variables including pain, trismus, swelling will be investigated at different times. Only the pharmacist knows the type of pills (placebo/bromelain) based on coding.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of the Disease by an Orthodontist and Surgery by a Maxillofacial Surgeon؛ Willingness to Cooperate؛ Not taking supplements for at least one month before. Exclusion criteria: Suffering from chronic diseases such as diabetes mellitus, kidney failure, liver disorder and cancer؛ Suffering from other autoimmune and inflammatory diseases؛ Suffering from hormonal disorders, thyroid disorders؛ Alcohol consumption and hookah use؛ Smoking and being exposed to secondhand smoke chronically؛ Unwillingness to participate in the study.
Intervention groups
Intervention group: consumption of 200 mg bromelain supplement capsule powder three times a day for 8 days Control group: consumption of powder inside the placebo capsule three times a day for 8 days
Main outcome variables
Evaluation of swelling, pain and mouth opening before and after the intervention

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230517058214N1
Registration date: 2023-06-19, 1402/03/29
Registration timing: prospective

Last update: 2023-06-19, 1402/03/29
Update count: 0
Registration date
2023-06-19, 1402/03/29
Registrant information
Name
Zahra Ghafariyan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 2081
Email address
ghaffariandz971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Bromelain on Pain, Swelling and Trismus after Surgery in Orthognathic Patients
Public title
The Effect of Bromelain on Pain, Swelling and Trismus after Orthognathic Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of the Disease by an Orthodontist and Surgery by a Maxillofacial Surgeon Willingness to Cooperate and Sign the Informed Consent Form after being fully informed about the objectives and method of conducting the study Not taking supplements for at least one month before
Exclusion criteria:
Suffering from chronic diseases such as diabetes mellitus, kidney failure, liver disorder and cancer Suffering from other autoimmune and inflammatory diseases Suffering from hormonal disorders, thyroid disorders Alcohol consumption and hookah use Smoking and being exposed to secondhand smoke chronically Unwillingness to participate in the study
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Since the two groups are supposed to have the same sample size, the block randomization method will be used in this study. Random block units will usually be used in order to balance the number of samples allocated to each study group. The size of the blocks will be chosen randomly, and each block contains an equal number of each group. The way to make the random sequence will be by the computer software "Random Allocation Software". Concealment of random allocation in sealed envelopes with random sequence will be done by a person who is not aware of the study process.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants, surgeons, orthodontists, and data and outcome analysts will not know how the groups were assigned. Placebo and bromelain capsules with a completely similar appearance are prepared by the pharmacist and provided to the researchers in plastic covers with the number specified by the pharmacist.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ghoreishi Building, Daneshgah avenue.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2023-03-11, 1401/12/20
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1401.155

Health conditions studied

1

Description of health condition studied
Class III with maxilla deficiency and mandible prognathism
ICD-10 code
K07.1
ICD-10 code description
Anomalies of jaw-cranial base relationship

Primary outcomes

1

Description
Evaluation of swelling before and after intervention
Timepoint
Days 1, 7, 30 after surgery will be compared with these measurements before surgery and immediately after surgery
Method of measurement
to evaluate the swelling of the total length of the considered lines in the anatomical areas of the face will be used

2

Description
2. Assessment of pain before and after intervention
Timepoint
Days 1, 7, 30 after surgery will be compared with these measurements before surgery and immediately after surgery
Method of measurement
Visual analogue scale will be used in this evaluation

3

Description
Evaluation of mouth opening before and after the intervention
Timepoint
Days 1, 7, 30 after surgery will be compared with these measurements before surgery and immediately after surgery
Method of measurement
with a ruler from the incisal edge of the centrals in the state of maximum mouth opening

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Taking bromelain 200 mg powder inside the capsule three times a day for 8 days
Category
Treatment - Drugs

2

Description
Control group: Taking the powder inside the placebo capsule three times a day for 8 days
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Oral and maxillofacial surgery department, Mashhad dental school
Full name of responsible person
Seyedeh Maryam Omidkhoda
Street address
Oral and maxillofacial surgery department, Mashhad dental school, Vakilabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7100
Email
omidkhodam@mums.ac.ir

2

Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Seyedeh Maryam Omidkhoda
Street address
Ahmadabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9176999311
Phone
+98 51 3801 2602
Email
omidkhodam@mums.ac.ir

3

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Seyedeh Maryam Omidkhoda
Street address
Imam Reza Hospital, Ibn Sina Street, Doctor's Crossroads, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
omidkhodam@mums.ac.ir

4

Recruitment center
Name of recruitment center
Mother Hospital
Full name of responsible person
Seyedeh Maryam Omidkhoda
Street address
Mother Hospital, 1st (Alley) The north of Bozorgmehr St, Sajad Blve, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9187833678
Phone
+98 51 3704 8000
Email
omidkhodam@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyedeh Maryam Omidkhoda
Street address
Mashhad Dental School, Vakil Abad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 917 112 8147
Email
omidkhodam@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Seyedeh Maryam Omidkhoda
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mashhad Dental School, Vakil Abad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 917 112 8147
Email
omidkhodam@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sahand Samiee Rad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mashhad Dental School, Vakil Abad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 912 813 7859
Email
samieerads@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Ghafariyan
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Mashhad Dental School, Vakil Abad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 930 210 7578
Email
ghaffariandz971@mums.ac.ir

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
All collected data would be shared for all researchers after the participants were unidentified.
When the data will become available and for how long
The access to data will be started 6 months after publication.
To whom data/document is available
The data would only be available for people working in academic institutions.
Under which criteria data/document could be used
It is allowed to use the data for meta-analysis and systematic reviews.
From where data/document is obtainable
The data can be obtained via email, from the corresponding researcher (Dr Seyedeh Maryam Omidkhoda). E-mail: omidkhodam@mums.ac.ir
What processes are involved for a request to access data/document
The new research proposal and the processes details should be e-mailed to corresponding researcher in order to get the access permission.
Comments
Loading...