Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201611001850216 Date of Approval: 04/11/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of an anti-inflammatory medication on the control of pain before orthodontic separators placement in children and adolescents: a single center randomized controlled trial
Official scientific title Effectiveness of a preemptive Ibuprofen on the control of pain before orthodontic separator placement in children and adolescents: a single center randomised controlled trial
Brief summary describing the background and objectives of the trial Background: Control of pain is an important part of the healthcare delivery. The placement of orthodontic separators is considered a routine dental work that could potentially cause some pain to the patients. It is therefore important to manage this postoperative pain during this routine dental procedure. A recent Cochrane review concluded that there is a low quality of evidence suggesting the effectiveness of a preoperative analgesic on pain control in children. Thus is it imperative that high quality research is needed in this area mandating the conduction of a well-designed prospective randomized controlled trials. Aims: To assess the effectiveness of a preoperative dose of ibuprofen on the pain control before placement of orthodontic separators. Participants and interventions: Children and adolescents 12-18 years will be recruited in this is single center prospective randomized controlled clinical trial assessing the effect of a preemptive dose of ibuprofen when compared to a placebo on the management of pain when an orthodontic separator is placed. Sixty subjects will be randomized on a 1:1 ratio . Investigator, caregiver and the subjects will be blinded to the allocation. A visual analogue scale will be used to assess the subject¿s pain experience on different occasions Funding: This study is self funded. Recruitment: Recruitment will be open for approximately 2 months, study is expected to end by June 2017. Dr. Hisham Mohammed Hishamyasser@hotmail.com
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health,Pain experienced by patients undergoing a regular separators placement in preparation for fitting orthodontic bands and braces
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 07/11/2016
Actual trial start date 08/11/2016
Anticipated date of last follow up 01/06/2017
Actual Last follow-up date 01/06/2017
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Computer generated random numbers Sequentially numbered drug containers with identical appearance Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ibuprofen one preemptive dose one hour before insertion of separators Patients will receive a preemptive dose of ibuprofen. The drug will be supplied in an effervescence form one hour before insertion of the orthodontic separators 30
Control Group Placebo One preemptive dose 1 hour before insertion of separators Patients will receive a preemptive dose of placebo The drug will be supplied in an effervescence form one hour before insertion of the orthodontic separators 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
12-18 years old children Willing to participate in the study No problems with swallowing All posterior teeth present up to the second molar Subjects on current antibiotic or analgesic medication Systematic disease, GIT problems Medical contraindication to ibuprofen Previous history of orthodontic treatment 12 Year(s) 18 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/10/2016 the ethical committee at El-Sahel teaching hospital, General Committee of Teaching Hospitals and Institutes, Egypt.
Ethics Committee Address
Street address City Postal code Country
2 Youssef Karam, Borham, As Sahel, Cairo Governorate Cairo 11697 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain assessed using a 100 mm Visual analogue scale (VAS) five different intervals (2 hours, 6 hours, bedtime, awakening, 24 hours)
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
El Sahel teaching hospital 2 Youssef Karam, Borham, As Sahel, Cairo Governorate Cairo 11697 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funding 2 Youssef Karam, Borham, As Sahel, Cairo Governorate Cairo 11697 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor El Sahel teaching Hospital 2 Youssef Karam, Borham, As Sahel, Cairo Governorate Cairo 11697 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mumen Rizk 6 Ahmed fouad st. Cairo 11697 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hisham Mohammed Hishamyasser@hotmail.com +201008105737 63 Al-fatth , Nasr City
City Postal code Country Position/Affiliation
Cairo 11727 Egypt Postgraduate student University of Dundee
Role Name Email Phone Street address
Public Enquiries Mumen Rizk moerizk@gmail.com +201117765448 6 St. Ahmed Nessim
City Postal code Country Position/Affiliation
Cairo Egypt Postgraduate student, University of Dundee, United kingdom
Role Name Email Phone Street address
Scientific Enquiries Amr Maged amr.maged@fue.edu.eg +201005849238 N 90th Street - Service Ln
City Postal code Country Position/Affiliation
Cairo 11853 Egypt Assistant lecturer, Department of Pharmaceutics and Pharmaceutical Technology, Future University
REPORTING
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