The purpose of this study was to investigate the effect of Bromelain on Controling the pain after an implant surgery and to compare its effectiveness with the commonly used drug is ibuprofen.
Design
Two arm parallel group randomised clinical trial design of 40 patients with single blinded
Settings and conduct
Among the patients referring to Implant Department of Tabriz Faculty of Dentistry, individuals who are eligible, will be informed .The patients were randomly divided into two groups of 20. For the first group, Ibuprofen 400mg was prescribed 5 days every 8 hours.For the second group, Bromelin 500 mg was prescribed for 5 days every 8 hours. Post-operative pain is initial outcome that will be assessed at 1, 3, 6, days after surgery with using visual analog scale (VAS). Also, patients are not aware of the drug and which group they are in.
Participants/Inclusion and exclusion criteria
inclusion criteria : Applicants without illness over the age of 18 who have not consumed any medication in the last two weeks. Applicant to replacement of missing teeth with implants in the first and second premolar regions of the maxilla or mandible. Based on CBCT assessments, there is a sufficient amount of bone in the toothless areas without the need for recovery and reconstruction.
exclusion criteria : Applicants with systemic diseases that are treated with other medications. Smokers and alcoholics. Applicants with poor oral hygiene. Applicants who need bone graft. Applicants who need more than two implants. Applicants with surgical duration more than 45 minutes.
Intervention groups
1-The group that received the Ibuplofen 400after dental implant surgery.
2-The group that received the Ibuplofen 400after dental implant surgery.
Main outcome variables
The main variable in this study is pain, which is measured by visual analog scale (VAS).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180513039628N1
Registration date:2018-08-29, 1397/06/07
Registration timing:registered_while_recruiting
Last update:2018-08-29, 1397/06/07
Update count:0
Registration date
2018-08-29, 1397/06/07
Registrant information
Name
Farhang Mahboub
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 5965
Email address
mahboubif@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-16, 1397/04/25
Expected recruitment end date
2019-01-05, 1397/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between Bromelain and Ibuprofen for postoperative pain control following dental implant placement surgery
Public title
Comparison between Bromelain and Ibuprofen for postoperative pain control following dental implant placement surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Applicants without illness over the age of 18 who have not consumed any medication in the last two weeks.
Applicant to replacement of missing teeth with implants in the first and second premolar regions of the maxilla or mandible.
Based on CBCT assessments, there is a sufficient amount of bone in the toothless areas without the need for recovery and reconstruction.
Exclusion criteria:
Applicants with systemic diseases that are treated with other medications
Smokers and alcoholics
Applicants with poor oral hygiene
Applicants who need bone graft
Applicants who need more than two implants
Applicants with surgical duration more than 45 minutes
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization of the samples is according to the expert's opinion using the Randlist software
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are aware of the two generic groups but they are not aware which group they are in.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee in biomedical researchs of Tabriz University of Medical Sciences
Street address
No.2 central buiding, Tabriz University of Medical Sciences, Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2017-08-14, 1396/05/23
Ethics committee reference number
IR.TBZMED.REC.1396.476
Health conditions studied
1
Description of health condition studied
Pain control following dental implant placement surgery
ICD-10 code
K00-K14
ICD-10 code description
Diseases of oral cavity, salivary glands and jaws
Primary outcomes
1
Description
pain intensity
Timepoint
day 1, 3 and 6 after surgery
Method of measurement
Visual analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group : in intervention group Bromelin ,500 mg (Bromelain500-Parmoon Amin -Iran-Tehran) was prescribed an oral tablet for 5 days every 8 hours.Post-operative pain is initial outcome that will be assessed at 1, 3, 6, days after surgery with using visual analog scale (VAS).
Category
Treatment - Drugs
2
Description
Control group:in control group , Ibuprofen 400mg (Ibuprofen400-Abidi-Iran-Tehran) was prescribed an oral tablet for 5 days every 8 hours. Post-operative pain is initial outcome that will be assessed at 1, 3, 6, days after surgery with using visual analog scale (VAS).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry
Full name of responsible person
Farhang Mahboub
Street address
Faculty of Dentistry, Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
mahboubif@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Abolghasem Jouyban
Street address
No.2 central buiding, Tabriz University of Medical Sciences, Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3334 1249
Email
mahboubif@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Farhang Mahboub
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Fax
Email
mahboubif@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farhang Mahboub
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Fax
Email
mahboubif@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farhang Mahboub
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Fax
Email
mahboubif@tbzmed.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The total potential data can be shared after unidentifiable Applicants.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Results are available to researchers and practitioner in the industry.
Under which criteria data/document could be used
No specific requirements.
From where data/document is obtainable
It can also be accessed via email.
mahboubif@tbzmed.ac.ir
What processes are involved for a request to access data/document
After sending the email, you can access it utmost a month later.