Actively Recruiting
Effect of Pre-medication With Anti-inflammatory Drugs (Ibuprofen and Dexamethasone) on Post-Endodontic Pain With Symptomatic Irreversible Pulpitis
Led by Armed Forces Institute of Dentistry, Pakistan · Updated on 2025-05-20
130
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effect of pre-medication with anti-inflammatory drugs, specifically ibuprofen and dexamethasone, on post-endodontic pain in patients with symptomatic irreversible pulpitis. This Phase 2 randomized and double-blind trial aims to compare these two drugs in managing pain after root canal treatment. The study will include adult patients aged 18 to 50 who have acutely inflamed pulp without swelling or draining sinus and are otherwise healthy. Participants will be divided into two groups, one receiving ibuprofen and the other dexamethasone as pre-medication 15 minutes before root canal treatment. The treatment involves local anesthesia, rubber dam isolation, working length determination, and instrumentation of the root canals using the ProTaper Next system with sodium hypochlorite irrigation. Calcium hydroxide will be used as an intra-canal medicament before temporary sealing. After instrumentation, patients will be recalled after one week for final obturation and restoration. During the study, patients will mark their pain intensity on a visual analogue scale at 24, 48, and 72 hours after the first visit. Severe pain will be managed with prescribed analgesics. Researchers will monitor the effect of pre-medication on post-endodontic pain at these time points. Patients must attend recall visits and provide written consent. The total study duration includes initial treatment and a one-week follow-up for final restoration.
CONDITIONS
Brief Title
Effect of Pre-medication With Anti-inflammatory Drugs(Ibuprofen and Dexamethasone)on Post-Endodontic Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Permanent teeth with acutely inflamed pulp without swelling or draining sinus.
- Patients of either gender aged between 18-50 years old.
- Systemically healthy patients.
- Patients who agree to attend recall appointments and provide written consent.
You will not qualify if you...
- Patients on preoperative analgesics and antibiotics.
- Teeth with calcified canals and previously treated teeth.
- Pregnant and lactating mothers.
- Patients who are immunocompromised, anxious, or mentally handicapped.
- Patients allergic to any of the test medications.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for history, clinical examination, and necessary tests including radiographs
Duration - Single treatment session with follow-up for 1 week
Participants receive pre-medication with either ibuprofen or dexamethasone 15 minutes before root canal treatment, which includes instrumentation, irrigation, and placement of intra-canal medicament.
1 treatment visit and 1 follow-up visit after 1 week
Duration - 72 hours post-treatment plus 1 week until final restoration
Participants record their pain intensity at 24, 48, and 72 hours after treatment using a pain scale. They return for obturation and final restoration after one week. Analgesics may be taken if severe pain occurs.
1 follow-up visit after 1 week; self-assessment at 24, 48, and 72 hours
Trial Site Locations
Total: 1 location
1
Armed Forces Institute Of Dentistry
Rawalpindi, Pakistan, 46000
Actively Recruiting
Research Team
Q
Quratulain Abbasi, BDS
M
Maha Ali Mirza, BDS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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