None listed
Conditions
Brief summary
Objectives of the study 1.3.1 General objective: • To evaluate the effectiveness of calcium supplementation compared to ibuprofen in reducing pain following orthodontic elastic separators placement using a randomized clinical trial design. 1.3.2 Specific objectives: • To assess the onset of pain relief and duration of action for both calcium and ibuprofen in a group of orthodontic patients. • To investigate any potential side effects associated with each treatment option. • To investigate the association of pain intensity with age and gender. Study hypothesis 1.4.1 Null hypothesis (H0): • There is no statistically significant difference in pain reduction between orthodontic patients who receive calcium supplementation and those who receive ibuprofen following orthodontic elastic separators placement. • There is no statistically significant association between pain intensity with age and gender of orthodontic patients who receive calcium supplementation and those who receive ibuprofen following orthodontic elastic separators placement. • There is no statistically significant difference in side effects prevalence between orthodontic patients who receive calcium supplementation and those who receive ibuprofen following orthodontic elastic separators placement. 1.4.2 Alternative hypothesis (H1): • There is statistically significant difference in pain reduction between orthodontic patients who receive calcium supplementation and those who receive ibuprofen following orthodontic elastic separators placement. • There is statistically significant association between pain intensity with age and gender of orthodontic patients who receive calcium supplementation and those who receive ibuprofen following orthodontic elastic separators placement. • There is statistically significant difference in side effects prevalence between orthodontic patients who receive calcium supplementation and those who receive ibuprofen following orthodontic elastic separators placement.
Interventions
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
Sponsors
Sadiq Abdullah Dhafir Hamud Atif, orthodontic resident university of Science and Technology
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to 28 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed