Active — Not RecruitingEarly Phase 1

Effect of Cryotherapy on Postoperative Pain for Pulpotomy

Thailand82 participantsStarted 2026-01-21

Plain-language summary

The goal of this clinical trial is to investigate the effect of cryotherapy on post-operative pain for pulpotomny in permanent mature carious posterior teeth with symptomatic irreversible pulpitis. The main question is: Do cryotherapy reduce post-operative pain and improve QoL in interested samples? \[primary hypothesis or outcome measure 1\] Post-operative pain by Numerical rating scale scores. \[primary hypothesis or outcome measure 2\] QoL of patients by OHIP-14 If there is a comparison group: Researchers will compare pulpotomy incorperated with cryotherapy and without. Participants will scoring VAS scores and OHIP-14 before and after treatment at designated time points.

Who can participate

Age range

18 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: * Healthy patients aged at least 18 years old with deep or extremely deep carious lesions in mature permanent posterior teeth diagnose with symptomatic irreversible pulpitis. Diagnoses are confirmed using Electric Pulp Test(EPT) and cold test. Pulpal and periapical diagnoses are based on terminology from the American Association of Endodontists (AAE, 2013). * Posterior teeth with moderate or severe pain according to the Visual Analog Scale(VAS):no pain(0), mild pain, non-disruptive to routine activity (1-3), moderate pain, interferes with daily life but no need analgesic intake (4-6) and severe pain, interferes with daily life and need analgesic intake (7-10). * Teeth that response negatively to percussion and palpation tests. * Teeth without periapical pathosis. * Teeth are restorable with direct composite restoration. Exclusion Criteria: * Teeth with subgingival caries and/or clinical attachment loss more than 3 mm and probing depth more than 4 mm. * Negative responses to pulp sensibility tests, presence of sinus tracts, swelling, non-restorable crowns, immature roots, or no pulp exposure following complete caries removal in case of pre-operative diagnosis as asymptomatic irreversible pulpitis. * Patients with systemic diseases involving bleeding disorders such as hemophilia, Von Willebrand disease, platelet disorders. And patients under taking all kind of anticoagulant and anti-platelet. * Patients who had taken analgesics or anti-inflammatory drugs …

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

Pain score

Timeframe: 6, 24, 48, 72, 96, 120, 148, 172, 196 hours after treatment

Trial details

NCT IDNCT07245004

SponsorSirawut Hiran-us

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

View on ClinicalTrials.gov More Pulpitis - Irreversible trials