Effect of DCS on Post-Endodontic Pain (NCT06632015) | Clinical Trial Compass
CompletedNot Applicable
Effect of DCS on Post-Endodontic Pain
Turkey (Türkiye)90 participantsStarted 2024-01-22
Plain-language summary
The aim of this randomized, triple-blind, parallel-group clinical trial was to evaluate the effects of calcium hydroxide (CH), diclofenac sodium (DCS), and their combination (CH+DCS) as intracanal medicaments on post-endodontic pain in mandibular molars diagnosed with symptomatic apical periodontitis. Ninety patients were randomly assigned to three groups (CH, DCS, or CH+DCS; n=30 each). Pain intensity was recorded using a 100 mm Visual Analog Scale (VAS) over 7 days following treatment, and the number of analgesic tablets taken was also recorded. Statistical analyses were performed using Kruskal-Wallis, Friedman, Wilcoxon signed-rank, and Chi-square tests, with significance set at 0.05. The null hypothesis stated that there would be no significant difference in post-endodontic pain among the groups.
Who can participate
Age range
18 Years – 60 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:
* Age between 18 and 60 years
* Systemically healthy (ASA I-II)
* Diagnosed with symptomatic irreversible pulpitis or symptomatic apical periodontitis in mandibular molars (characterized by spontaneous pain or prolonged pain in response to cold test, and presence of percussion sensitivity)
* Positive response to Electric Pulp Testing (EPT) and cold testing
* Periapical Index (PAI) score of 1 or 2 according to Ørstavik et al. (1986)
* Pre-operative pain level ≥50 mm on the Visual Analog Scale (VAS), which ranges from 0 (no pain) to 100 (most severe pain)
Exclusion Criteria:
* History of psychiatric disorders
* Allergic reactions
* Pregnancy
* Use of analgesics within the previous 24 hours
* Use of antibiotics within the last 3 months
* Teeth with a sinus tract or history of abscess formation
* Periodontal pocket depth \>3 mm
* Root resorption, root fractures, or ankylosis
* Previous root canal treatment on the selected tooth
* Teeth requiring prosthetic restoration
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.