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Effect of preemptive ibuprofen analgesic compared to placebo on pain perception associated with the placement of temporary anchorage devices (TADs), A double blinded randomised clinical trial

Protocol summary

Study aim
Effect of preemptive ibuprofen analgesic compared to placebo on pain perception associated with the placement of temporary anchorage devices (TADs),
Design
A multicenter, randomized controlled trial, double-masked trial, parallel group.
Settings and conduct
A multicenter, randomized, double-masked trial, The Research will consist of 2 groups of 25 participants each, the medication (Ibuprofen and placebo) will be given to both groups thirty minutes before the TAD placement, 400 mg Ibuprofen (Advil، Pfizer Inc.) for the first group and placebo for the second group. Patients will be asked to fill the questionnaire form (translated SF-MPQ) and Discomfort and severity of pain will be recorded at the following times: immediately after TAD placement (T1), 1 hour after TAD placement (T2), 12 hours after TAD placement (T3), 24 hour after TAD placement (T4).
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Patients treated with fixed orthodontic appliances 2- Patients that only need one TAD in the posterior part of the maxilla 3- Patients with minimum age of 13 years old 4- Patients that will agree to participate in the clinical trial Exclusion criteria: 1- Patients with poor oral hygiene or severe gingivitis 2- Patients with systemic diseases 3- Patients who currently are using other pain killer medications 4- Patients who are allergic to any of TAD, Ibuprofen, or Placebo medication 5- Patients who can not swallow
Intervention groups
A multicenter, randomized, double-masked trial, The Research will consist of 2 groups of 25 participants each, the medication (Ibuprofen and placebo) will be given to both groups thirty minutes before the TAD placement, 400 mg Ibuprofen (Advil، Pfizer Inc.) for the first group and placebo for the second group.
Main outcome variables
Determining severity and type of pain

General information

Reason for update
Acronym
RCT
IRCT registration information
IRCT registration number: IRCT20210803052059N1
Registration date: 2022-03-07, 1400/12/16
Registration timing: registered_while_recruiting

Last update: 2022-03-07, 1400/12/16
Update count: 0
Registration date
2022-03-07, 1400/12/16
Registrant information
Name
Arman Mohammadi Shayan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3661 4341
Email address
mohammadishayan@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-09, 1400/11/20
Expected recruitment end date
2022-03-11, 1400/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of preemptive ibuprofen analgesic compared to placebo on pain perception associated with the placement of temporary anchorage devices (TADs), A double blinded randomised clinical trial
Public title
Effect of preemptive ibuprofen analgesic compared to placebo on pain perception associated with the placement of temporary anchorage devices (TADs), A double blinded randomised clinical trial
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Patients treated with fixed orthodontic appliances Patients that only need one TAD in the posterior part of the maxilla Patients that will agree to participate in the clinical trial
Exclusion criteria:
Patients with poor oral hygiene or severe gingivitis Patients with systemic diseases Patients who currently are using other pain killer medications Patients who are allergic to any of TAD, Ibuprofen, or Placebo medication Patients who can not swallow
Age
From 13 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
Each individual represents a unit in the randomization method (46 individuals = 46 units), patients are randomly allocated in to blocks thus in to one of the arms using simple random sampling by using a computer softwarethe (Randlist v1.5), the two arms in the trial were placebo group and ibuprofen group and the block size was fixed to 6 individuals per block. The seed for random generator was (1786741248), then after the list was generated allocation concelment was carried out.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both Ibuprofen and Placebo will be packed in unclear packages and will be given to the patient by the assistance without the patient or the orthodontist knowing witch medication are in the package, for identifying the group no. 1 and 2 was written on the packages.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Central building of Tabriz medical university / gulgasht st. / Azadi st. / Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2021-10-25, 1400/08/03
Ethics committee reference number
IR.TBZMED.REC.1400.716

Health conditions studied

1

Description of health condition studied
Malocclusion, Dental crowding.
ICD-10 code
M26
ICD-10 code description
Anomalies of dental relationship

Primary outcomes

1

Description
Severity and type of pain during different times
Timepoint
severity and type of pain will be recorded at the following times: immediately after TAD placement (T1), 1 hour after TAD placement (T2), 12 hours after TAD placement (T3), 24 hour after TAD placement (T4).
Method of measurement
The patients will be asked to fill a questionnaire form, this form is consisted of a Persian translated copy of short form of McGill Pain questionnaire (SF-MPQ).

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 25 participants, the medication (400 mg Ibuprofen (Advil، Pfizer Inc.)) will be given to the first groups thirty minutes before the TAD placement.
Category
Prevention

2

Description
Control group: 25 participants, the medication (Placebo) will be given to the second groups thirty minutes before the TAD placement.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences, Faculty of Dentistry
Full name of responsible person
Hezha Shafiq H. Rashid
Street address
Dentiistry faculty / Tabriz University of Medical Science / Gulgasht st. / Azadi st. / Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 5965
Fax
Email
info@dentistryfac.tbzmed.ac.ir
Web page address
https://dentistryfac.tbzmed.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samie
Street address
Dentiistry faculty / Tabriz University of Medical Science / Gulgasht st. / Azadi st. / Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 5965
Email
info@dentistryfac.tbzmed.ac.ir
Web page address
https://dentistryfac.tbzmed.ac.ir/
Grant name
Research Ethics Committees of Tabriz University of medical sciences
Grant code / Reference number
IR.TBZMED.REC.1400.716
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
1
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
Arman Mohammadi Shayan
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No 111, Niavaran 6 Building, Kaj Street, Roshdiyeh
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3661 4341
Fax
Email
mohammadishayan@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Arman Mohammadi Shayan
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No 111, Niavaran 6 Building, Kaj Street, Roshdiyeh
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3661 4341
Fax
Email
mohammadishayan@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Arman Mohammadi Shayan
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No 111, Niavaran 6 Building, Kaj Street, Roshdiyeh
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3661 4341
Fax
Email
mohammadishayan@tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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