Comparison of Inter-appointment Pain Reduction During Root Canal Treatment in Symptomatic Apical … (NCT07198919) | Clinical Trial Compass
By InvitationPhase 1/2
Comparison of Inter-appointment Pain Reduction During Root Canal Treatment in Symptomatic Apical Periodontitis by Using Intracanal Medicaments; Chlorhexidine Gel and Single Antibiotic Paste Nitrofurantoin
Pakistan220 participantsStarted 2025-05-20
Plain-language summary
This study is being conducted to find out which of two medications-Chlorhexidine Gel or Nitrofurantoin-works better in reducing pain between root canal treatment visits. Sometimes, patients with infected teeth (called symptomatic apical periodontitis) continue to feel pain between treatment appointments. To help with this, dentists use medications inside the cleaned tooth canal.
In this trial, 220 patients will be divided into two groups. One group will receive Chlorhexidine Gel, and the other will receive Nitrofurantoin paste inside their tooth during the first treatment visit. Pain levels will be recorded before treatment, and again after 24 and 48 hours using a pain scale from 0 (no pain) to 10 (severe pain). No pain medicine will be given unless the patient feels very uncomfortable.
The study is taking place at the Altamash Institute of Dental Medicine in Karachi, and will help dentists understand which medication helps patients feel better faster during root canal treatment.
Who can participate
Age range
16 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with single rooted permanent teeth of both arches.
* Patients with a pulpal status of necrosis with or without periapical radiolucency, confirmed using Electric Pulp Test (EPT) and Cold Test.
* Male and female patients age of 16 to 45 yrs.
* Patients of both genders.
Exclusion Criteria:
* Patients with uncontrolled diabetes.
* Presence of periapical granuloma or cyst confirmed via radiographic evaluation.
* Patient is on any medication that affects pain, inflammation and infection like analgesic, antibiotics since last 7 days
* Patient requiring endodontic re-treatment.
* Patients with immature teeth with open apices.
* Patients with calcified canals.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage Reduction in Inter-Appointment Pain Score
Timeframe: Pain scores will be assessed before treatment, then at 24 hours and 48 hours after the first treatment visit.