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Post Endodontic PainEarly Phase 1NCT07400471

The Effects of Preemptive Multimodal Analgesic on Endodontic Pain Following Root Canal Therapy.

A Early Phase 1 study testing Pregabalin- Acetaminophen and Duloxetine- Acetaminophen in people with Post Endodontic Pain and Mechanical Detection Threshold, run by Chattogram International Dental College at 1 site in Bangladesh.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

A clinical trial comparing preemptive multimodal analgesics with placebo in the management of immediate and chronic post-endodontic pain. The study utilizes statistical methods such as chi-squared, T-tests, and regression analysis, accounting for multiple outcomes with the Bonferroni adjustment. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Pregabalin- Acetaminophen and Duloxetine- Acetaminophen
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
280 participants
Where
1 siteBangladesh
Study dates
6 Feb 2026to 30 Apr 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patient's aged 18 years more.
  • ASA physical status I-II.
  • Patient with the complain of pain originated from teeth and surrounding structure.
  • Preoperative pain severity is moderate to severe.
  • Patient can be able to make communication about their pain.
  • Patients give consent to attain this research.
Show all 10Show fewer
  • Patients have others concomitant chronic pain.
  • Patients who will have non-surgical endodontic treatment.
  • Patients who will have non-surgical endodontic retreatment.
  • Patients who will have surgical endodontic treatment.

Who cannot join

  • Patient would not like to attain in research.
  • Patients have any medical condition those are contra indication for study drug.
  • ASA physical status III, IV, V.
  • Patient already under treated any anti convulsent drug.
  • Patient participant in other clinical trials.
  • Lack of motivation or poor adharence to study protocols.
Show all 12Show fewer
  • Patient with Pregnancy
  • Severe organ dysfunction
  • Patient have Hepatitis B, and other cross infection disease like (HIV)
  • Uncontrolled comorbidities that patient do not fit for endodontic treatment.
  • Severe cognitive impaired patients.
  • History of certain cancers or severe hematological issues.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Prof.Dr. Md. Abu Saeed Ibn Harun, MS contact

8801711157586

dr.abusaeed@cidch.edu.bd

Bangladesh1 site, 1 recruiting
  • Professor. Dr. Md. Abu Saeed Ibn Harun

    Chittagong, Chattogram, 4212

    Prof. Dr. Md. Abu Saeed Ibn Harun, MS, 8801711157586, dr.abusaeed@cidch.edu.bd

    Mohammad Kamrul Islam, FCPS, 8801818247435, dr.kamrul11@gmail.com

    Recruiting

Other trials in Bangladesh

About this study

Official title: The Effects of Preemptive Multimodal Analgesic on Endodontic Pain.

A clinical trial comparing preemptive multimodal analgesics with placebo in the management of immediate and chronic post-endodontic pain. The study utilizes statistical methods such as chi-squared, T-tests, and regression analysis, accounting for multiple outcomes with the Bonferroni adjustment. Duloxetine hydrochloride and pregabalin, both available in Bangladesh, are evaluated as experimental drugs, while placebos are used to assess psychological effects on pain. All participants receive standard interventional treatments, with acetaminophen provided as needed, and ethical considerations are addressed according to international guidelines.

Being tested
Pregabalin- Acetaminophen, Duloxetine- Acetaminophen
Keywords
post endodontic pain, Root canal Therapy, Multimodal Analgesia, Dynamic sensory test

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pregabalin- AcetaminophenDrug

    Preemptive Multi modal analgesic drug: Experimental group will be divided into 2 subgroups according to use of drug.

    1. Pregabalin-acetaminophen. B. Duloxetine-Acetaminophen Pregabalin-acetaminophen: Before a half-hour endodontic treatment, patients in this group will receive a single dosage of 50 mg pregabalin and 500 mg acetaminophen. If necessary, acetaminophen dosages of 500 mg will be administered three times a day.
  • Duloxetine- AcetaminophenDrug

    Duloxetine-Acetaminophen: Prior to a half-hour endodontic treatment, patients in this group will receive a single dosage of 500 mg of acetaminophen and 30 mg of Duloxetine. If necessary, acetaminophen dosages of 500 mg will be administered three times a day.

Study groups in NCT07400471
Study groupRoleWhat they receive
Multimodal AnalgesiaActive comparatorPreemptive Multi modal analgesic drug: Experimental group will be divided into 2 subgroups according to use of drug. A. Pregabalin-acetaminophen. B. Duloxetine-Acetaminophen Pregabalin-acetaminophen: Before a half-hour endodontic treatment, patients in this group will receive a single dosage of 50 mg pregabalin and 500 mg acetaminophen. If necessary, acetaminophen dosages of 500 mg will be administered three times a day. Duloxetine-Acetaminophen: Prior to a half-hour endodontic treatment, patients in this group will receive a single dosage of 500 mg of acetaminophen and 30 mg of Duloxetine. If necessary, acetaminophen dosages of 500 mg will be administered three times a day.
Receives: Drug: Pregabalin- Acetaminophen; Drug: Duloxetine- Acetaminophen
ControlPlacebo comparatorPlacebo: Patient in this group will receive placebo drug before half an hour of operating procedure. If necessary, acetaminophen dosages of 500 mg will be administered three times a day and noted
Receives: Drug: Pregabalin- Acetaminophen; Drug: Duloxetine- Acetaminophen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effects of Preemptive multimodal analgesia on post endodontic pain

    Primary Pain during endodontic treatment and the effectiveness of intervention will be evaluated at 6, 12, 24, 48, 72, and hourly intervals after the endodontic procedure. Treatment-related anaesthetic efficacy will be assessed using the VAS (Visual Analogue Scale; numerical value 0-10). During endodontic treatment, the level of pain will decide how effective the anesthetic is. The patient will be asked to rate the analgesic effects on a VAS (Visual Analogue Scale) scale by providing a numerical number 0-10. '0" are indicated no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= sever pain.

    Measured: 6, 12, 24, 48, 72 hours

Secondary outcomes (3)
  1. Mechanical Detection Threshold

    Mechanical Detection Threshold: A standardized set of modified von Frey hairs (Opti-hair2-Set, Marstock Nervtest, Germany) that exert stresses upon bending between 0.25 and 512 mN graded by a factor of 2 (1-2 s contact time) were used to determine the mechanical detection threshold (MDT). With a rounded tip and 0.5 mm in diameter, the von Frey hairs' contact area with the skin was consistent in size and shape to prevent sharp edges that could aid in nociceptor activation. Five threshold determinations with a sequence of increasing and decreasing stimulus intensities were made using the "method of limits." The geometric mean of these five series served as the final threshold.

    Measured: baseline, 72 hours

  2. Mechanical Pain Threshold

    Mechanical Pain Threshold: A set of seven pin-prick mechanical stimulators with preset stimulus intensities (flat contact area of 0.2 mm diameter) that applied forces of 8, 16, 32, 64, 128, 256, and 512 mN were used to test the mechanical pain threshold (MPT). These stimuli were custom-made and weighted. Until the first perception of sharpness was attained, the stimulators were applied in ascending order at a pace of two seconds on, two seconds off. The geometric mean of five sequences of rising and descending stimuli served as the final threshold. The purpose of this test was to identify pinprick hypoalgesia. Before initiation of endodontic treatment, the patient has to take drug that's are supplied in enveloped.

    Measured: baseline, 72 hours

  3. Mechanical Pain Sensitivity

    Mechanical Pain Sensitivity will test using the same weighted pinprick stimuli as for mechanical pain threshold. To obtain a stimulus- response- function, these seven pinprick stimuli will apply in a balanced order, five times each, and patient will ask to give a pain rating for each stimulus on a 0-10 VAS scale ( '0' indicate no pain; 10 indicate most intense pain imaginable.

    Measured: baseline, 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2026
  2. Study start6 Feb 2026 (estimated)
  3. Primary completion30 Mar 2027 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07400471
Sponsor's protocol ID
ERC-BBS/2025/0015-44/2025
Status last verified
Feb 2026
First submitted
26 Jan 2026
Last updated
11 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Anibal Diogenes, Michael A. Henry. Pain Pathways and Mechanisms of the Pulpodentin Complex. Chapter 8; Seltzer and Bender's Dental Pulp. 2nd edition. Quintessence Publishing Co Inc;2012.

  • Jang YE, Kim Y, Kim BS. Influence of Preoperative Mechanical Allodynia on Predicting Postoperative Pain after Root Canal Treatment: A Prospective Clinical Study. J Endod. 2021 May;47(5):770-778.e1. doi: 10.1016/j.joen.2021.01.004. Epub 2021 Jan 29.

    PubMed 33516824
  • Alelyani AA, Azar PS, Khan AA, Chrepa V, Diogenes A. Quantitative Assessment of Mechanical Allodynia and Central Sensitization in Endodontic Patients. J Endod. 2020 Dec;46(12):1841-1848. doi: 10.1016/j.joen.2020.09.006. Epub 2020 Sep 15.

    PubMed 32941893
  • Wiech K, Ploner M, Tracey I. Neurocognitive aspects of pain perception. Trends Cogn Sci. 2008 Aug;12(8):306-13. doi: 10.1016/j.tics.2008.05.005. Epub 2008 Jul 5.

    PubMed 18606561
  • Md. Abu Saeed Ibn Harun et al. The dimension and severity of orofacial pain in patients with current and chronic odontogenic pain. M Dent J 2021; 41(3): 235-244.

  • Woolf CJ. Windup and central sensitization are not equivalent. Pain. 1996 Aug;66(2-3):105-8. No abstract available.

    PubMed 8880830
  • Md. Abu Saeed Ibn Harun et al. Endogenous Pain modulation of Irreversible Pulpitis and Persistent Endodontic Pain. Chattagram International Dental College Journal 2019; 2(1):9-13.

  • O'Keefe EM. Pain in endodontic therapy: preliminary study. J Endod. 1976 Oct;2(10):315-9. doi: 10.1016/S0099-2399(76)80047-7. No abstract available.

    PubMed 1068208
  • Doleman B, Leonardi-Bee J, Heinink TP, Boyd-Carson H, Carrick L, Mandalia R, Lund JN, Williams JP. Pre-emptive and preventive NSAIDs for postoperative pain in adults undergoing all types of surgery. Cochrane Database Syst Rev. 2021 Jun 14;6(6):CD012978. doi: 10.1002/14651858.CD012978.pub2.

    PubMed 34125958
  • Price DD, Finniss DG, Benedetti F. A comprehensive review of the placebo effect: recent advances and current thought. Annu Rev Psychol. 2008;59:565-90. doi: 10.1146/annurev.psych.59.113006.095941.

    PubMed 17550344
  • Ince B, Ercan E, Dalli M, Dulgergil CT, Zorba YO, Colak H. Incidence of postoperative pain after single- and multi-visit endodontic treatment in teeth with vital and non-vital pulp. Eur J Dent. 2009 Oct;3(4):273-9.

    PubMed 19826598
  • Al-Nahlawi T, Alabdullah A, Othman A, Sukkar R, Doumani M. Postendodontic pain in asymptomatic necrotic teeth prepared with different rotary instrumentation techniques. J Family Med Prim Care. 2020 Jul 30;9(7):3474-3479. doi: 10.4103/jfmpc.jfmpc_342_20. eCollection 2020 Jul.

    PubMed 33102316
  • Nixdorf DR, Moana-Filho EJ, Law AS, McGuire LA, Hodges JS, John MT. Frequency of persistent tooth pain after root canal therapy: a systematic review and meta-analysis. J Endod. 2010 Feb;36(2):224-30. doi: 10.1016/j.joen.2009.11.007.

    PubMed 20113779
  • Oshima K, Ishii T, Ogura Y, Aoyama Y, Katsuumi I. Clinical investigation of patients who develop neuropathic tooth pain after endodontic procedures. J Endod. 2009 Jul;35(7):958-61. doi: 10.1016/j.joen.2009.04.017.

    PubMed 19567314
  • Hargreaves KM, BermanLH, Cohen S. Cohen's Pathways of the Pulp. 11th ed. Amsterdam, Netherlands: Elsevier; 2015.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Pregabalin- Acetaminophen and Duloxetine- Acetaminophen in people with Post Endodontic Pain and Mechanical Detection Threshold, run by Chattogram International Dental College at 1 site in Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Prof.Dr. Md. Abu Saeed Ibn Harun, MS (8801711157586, dr.abusaeed@cidch.edu.bd), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effects of Preemptive multimodal analgesia on post endodontic pain (time frame: 6, 12, 24, 48, 72 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07400471, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.

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