Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000402448
Ethics application status
Approved
Date submitted
21/11/2024
Date registered
2/05/2025
Date last updated
2/05/2025
Date data sharing statement initially provided
2/05/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of calcium versus ibuprofen in reducing pain among a group of orthodontic patients
Scientific title
The effectiveness of calcium versus ibuprofen in reducing pain among a group of orthodontic patients
Secondary ID [1] 313439 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Orthodontic Pain 335817 0
Condition category
Condition code
Anaesthesiology 332395 332395 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Application of pain trigger (Orthodontic Separator Placement) to the the participants by the main researcher by using separator placement plier
The duration of the procedure is approximately two minutes
The orthodontic elastic separator will remain in place one week after and experience of pain relief
Ibuprofen 500 mg oral tablet is taken two hours after procedure one tablet daily for one week
strategy used to monitor adherence to the intervention by tablet count
Intervention code [1] 330005 0
Treatment: Drugs
Comparator / control treatment
Application of pain trigger (Orthodontic Separator Placement) for one week and experience of pain relief
Calcium citrate 350 mg oral tablet is taken two hours after procedure one tablet daily for one week
strategy used to monitor adherence to the intervention by tablet count
Control group
Active

Outcomes
Primary outcome [1] 339948 0
Depression and anxiety levels of the participants will be assessed as a composite outcome”
Timepoint [1] 339948 0
At the visit of orthodontic separator placement
Primary outcome [2] 340153 0
Pain Assessment
Timepoint [2] 340153 0
Baseline, 2 hours, 6 hours, bed time, 2 days, 3 days, 7 days post orthodontic separator placement
Secondary outcome [1] 444324 0
Patient satisfaction with analgesics
Timepoint [1] 444324 0
5 minutes to explain their experience

Eligibility
Key inclusion criteria
1. Patients who need orthodontic treatment with fixed orthodontic appliances (braces).
2. Early adult patients aged 18-28 years old.
3. Patients who are scheduled for a specific orthodontic procedure known to cause pain (separator placement).
4. Orthodontic patients who are generally healthy with no major medical conditions that could influence pain perception or medication use such as chronic pain, ventricular filtration, renal calculi, kidney diseases, uncontrolled diabetes mellitus, bleeding disorders, hyperthyroidism and calcium supplement intake.
5. Absence of allergies to calcium or ibuprofen.
6. Willingness, ability, and understanding to adhere to the study protocol, including taking medications as instructed and attending follow-up assessments.
7. Initial pain intensity between 40 and 100 mm (VAS).
8. Initial Hospital Anxiety Depression Scale (HADS) scoring between 0 and 10.
Minimum age
18 Years
Maximum age
28 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnancy or breastfeeding.
2. Taking medications that could interact with calcium or ibuprofen, such as thyroid medications, bisphosphonates, diuretics, corticosteroids, other NSAID, and blood thinners.
3. Previous participation in a similar study within a specific timeframe.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The following strategies will be used:
• Sealed Opaque Envelopes: Sealed envelopes containing allocation assignments will be used to maintain concealment until the point of enrollment.
• Pharmacy Dispensing: Partnership (My colleague Dr: Ali Al-fahd) will be made to dispense coded medications based on the participant's enrollment ID. The Partnership will maintain the allocation list and dispense the appropriate blinded medication without revealing the group assignment to the researcher.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
• Pain Scores (Continuous Data): Since pain scores are measured on a continuous scale (e.g., VAS), the following statistics will be conducted:
o Descriptive Statistics: Pain scores will be calculated for each group (calcium, ibuprofen, placebo) using measures like mean, standard deviation, and median. This will provide a basic understanding of how pain scores are distributed within each group.
o Analysis of Variance (ANOVA): This method will compare the mean pain scores between the three groups (calcium, ibuprofen, placebo) at each time point (baseline, post-procedure intervals). It will allow to assess whether there are statistically significant differences in pain levels among the groups.
o Post-hoc Tests: If ANOVA reveals significant differences, using post-hoc tests (e.g., Tukey's HSD) to identify which specific group pairs differ from each other in terms of pain scores.
• Onset and Duration of Pain Relief (Categorical Data):
o Chi-Square Test: This test will assess whether the distribution of these categories (onset or duration of pain relief) differs significantly between the groups.
Statistical Software:
• The data analysis will be performed using: SPSS V.25 (SPSS, JASP).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
14/12/2024
Date of last participant enrolment
Anticipated
3/05/2025
Actual
Date of last data collection
Anticipated
24/05/2025
Actual
Sample size
Target
81
Accrual to date
3
Final
Recruitment outside Australia
Country [1] 26750 0
Yemen
State/province [1] 26750 0
Country [2] 26779 0
Saudi Arabia
State/province [2] 26779 0

Funding & Sponsors
Funding source category [1] 317875 0
Self funded/Unfunded
Name [1] 317875 0
Sadiq Abdullah Dhafir Hamud Atif,orthodontic resident
Country [1] 317875 0
Yemen
Primary sponsor type
Individual
Name
Sadiq Abdullah Dhafir Hamud Atif, orthodontic resident university of Science and Technology
Address
Country
Yemen
Secondary sponsor category [1] 320385 0
None
Name [1] 320385 0
Address [1] 320385 0
Country [1] 320385 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316559 0
USTY Medical Research Ethics Committee
Ethics committee address [1] 316559 0
Ethics committee country [1] 316559 0
Yemen
Date submitted for ethics approval [1] 316559 0
17/11/2024
Approval date [1] 316559 0
24/11/2024
Ethics approval number [1] 316559 0
1446/0031/UREC/UST

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138254 0
Mr Sadiq Abdullah Dhafir Hamud Atif
Address 138254 0
University of Science and Technology, Sana’a, Yemen,60th street 00967
Country 138254 0
Yemen
Phone 138254 0
+967774719858
Fax 138254 0
Email 138254 0
[email protected]
Contact person for public queries
Name 138255 0
Sadiq Abdullah Dhafir Hamud Atif
Address 138255 0
Yemen, Sana’a, 6th street, university of Science and Technology 00967
Country 138255 0
Yemen
Phone 138255 0
+967774719858
Fax 138255 0
Email 138255 0
[email protected]
Contact person for scientific queries
Name 138256 0
Sadiq Abdullah Dhafir Hamud Atif
Address 138256 0
Yemen, Sana’a, 6th street, university of Science and Technology 00967
Country 138256 0
Yemen
Phone 138256 0
+967774719858
Fax 138256 0
Email 138256 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.