A Comparative Evaluation of the Degree of Pain and MMP-9 Expression Following Instrumentation of … (NCT07101003) | Clinical Trial Compass
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A Comparative Evaluation of the Degree of Pain and MMP-9 Expression Following Instrumentation of Necrotic Pulps With Apical Periodontitis in One or Two Visits
28 participantsStarted 2025-08-01
Plain-language summary
This randomized clinical trial compares postoperative pain and MMP-9 levels after root canal treatment of necrotic teeth with apical periodontitis, using either single-visit or two-visit instrumentation. The primary outcome is pain intensity measured at multiple intervals using a Visual Analogue Scale. The secondary outcome is the periapical expression of MMP-9 assessed via ELISA. The trial aims to determine whether treatment timing impacts inflammation and healing.
Who can participate
Age range
18 Years – 40 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 18-40 years.
* Males/Females.
* Straight single canaled permanent teeth:
* Non-Vital pulps.
* Negative response to cold pulp tester (ethyl chloride spray\*).
* Absence of spontaneous pain.
* Chronic apical periodontitis with negative response to percussion
* Slight widening in the periodontal membrane space or with periapical radiolucency not exceeding 2\*2 mm radiographically. The Periapical Index (PAI) score by Ørstavik is 2 or 3 (Ørstavik et al., 1986 43)
* Systemically healthy patients (ASA I or II)
* No anti-inflammatory or antibiotic medications taken in the past month
* Patients' acceptance to participate in the trial.
* Patients who can understand pain scale and can sign the informed consent (Appendix I).
* Patients' acceptance to participate in the trial.
Exclusion Criteria:
* Medically compromised patients having significant systemic disorders. (ASA III or IV).
* Teeth with swelling or fistulous tract.
* Teeth with acute or chronic periapical abscess.
* Mobility Grade II or III.
* Previous root canal therapy.
* Non-restorable teeth.
* Immature teeth.
* Pregnant females.
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
Post instrumentation Pain
Timeframe: At 6,12, 24, 48 and 72 hours post instrumentation