Preemptive multimodal pain control for pain after root canal therapy
Official title: The Effects of Preemptive Multimodal Analgesic on Endodontic Pain.
Run by Chattogram International Dental College · NCT07400471 · Data updated 2026-11-12
This trial will test whether taking pregabalin or duloxetine together with acetaminophen before root canal treatment reduces immediate and longer‑term post‑endodontic pain in adults.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 280 (estimated) |
| Sponsor | Chattogram International Dental College Academic / other |
| Locations | 1 site (Chittagong, Chattogram) |
| Status | Recruiting |
| Started | February 6, 2026 |
| Main results expected | March 30, 2027 |
| Study ends | April 30, 2027 |
| Registry record updated | February 11, 2026 |
| Trial ID | NCT07400471 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with ASA I–II who have moderate to severe tooth pain originating from the tooth or surrounding structures and who are scheduled for non‑surgical or surgical endodontic treatment and can provide informed consent are ideal candidates.
✕Probably not a fit
Patients who are pregnant, have severe organ dysfunction, are ASA III–V, are already taking anticonvulsant medications, or have contraindications to the study drugs are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study compares preemptive multimodal analgesic regimens (pregabalin plus acetaminophen or duloxetine plus acetaminophen) against placebo given alongside standard endodontic care to adults with moderate to severe preoperative tooth pain. Participants who meet inclusion criteria will receive the assigned medication before undergoing non‑surgical or surgical endodontic procedures, with pain and sensory responses measured immediately and during follow‑up. Outcomes include immediate and chronic post‑endodontic pain, mechanical pain thresholds, and sensory testing, analyzed using chi‑square, t‑tests, and regression with Bonferroni correction for multiple comparisons. Placebo arms are included to help separate pharmacologic from psychological effects, and acetaminophen is available as rescue medication per protocol.
Why it matters
Potential benefit: If effective, the approach could reduce both immediate and persistent pain after root canal procedures and decrease reliance on rescue analgesics.
How similar studies have gone: There is some evidence that pregabalin and duloxetine can help neuropathic and postoperative pain, but their preemptive use specifically for post‑endodontic pain is relatively limited and not well established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient's aged 18 years more. 2. ASA physical status I-II. 3. Patient with the complain of pain originated from teeth and surrounding structure. 4. Preoperative pain severity is moderate to severe. 5. Patient can be able to make communication about their pain. 6. Patients give consent to attain this research. 7. Patients have others concomitant chronic pain. 8. Patients who will have non-surgical endodontic treatment. 9. Patients who will have non-surgical endodontic retreatment. 10. Patients who will have surgical endodontic treatment. Exclusion Criteria: 1. Patient would not like to attain in research. 2. Patients have any medical condition those are contra indication for study drug. 3. ASA physical status III, IV, V. 4. Patient already under treated any anti convulsent drug. 5. Patient participant in other clinical trials. 6. Lack of motivation or poor adharence to study protocols. 7. Patient with Pregnancy 8. Severe organ dysfunction 9. Patient have Hepatitis B, and other cross infection disease like (HIV) 10. Uncontrolled comorbidities that patient do not fit for endodontic treatment. 11. Severe cognitive impaired patients. 12. History of certain cancers or severe hematological issues.
Where it's running
-
Professor. Dr. Md. Abu Saeed Ibn Harun
Chittagong, Chattogram, Bangladesh Recruiting
Study contacts
- Study coordinator: Prof.Dr. Md. Abu Saeed Ibn Harun, MS
- Email: dr.abusaeed@cidch.edu.bd
- Phone: 8801711157586
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Influence of Sealer Composition on Post-Endodontic Pain
This study tests whether a calcium hydroxide–based sealer affects post-endodontic pain after primary root canal treatment in people with acute irreversible pulpitis.
-
Effect of anti-inflammatory drugs on pain after root canal treatment
This study is testing whether taking ibuprofen or dexamethasone before a root canal can help reduce pain afterward for people with severe tooth issues.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.