Effect of Cryotherapy on Postoperative Pain for Pulpotomy

NCT07245004 | Active Not Recruiting Early Phase 1

• 1 other identifier: BBC 32/2025
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulpitis - Irreversible

Keywords

Pulpotomy; Cryotherapy

Outcome Measures

Primary Outcomes (1)

• Pain score

  Pain was recorded using a numerical rating scale (NRS) which minimum is 0 and maximum is 10. Higher scores indicate worse pain, while lower scores indicate better outcomes.

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

Secondary Outcomes (1)

• Patient quality of life

  Before treatment and at 7 days after treatment

Study Arms (2)

Addition of Cryotherapy on pulpotomy

EXPERIMENTAL

After hemostasis is achieved, the pulpotomy area is irrigated for 5 minutes with normal saline solution, which is kept in the refrigerator set to 2.5°C (measuring with thermometer and record) by using a disposable insulated 5 ml syringe and 21-gauge needle is placed 1-2 mm above the root canal orifices and is constantly moved in a circular motion: 5 ml in each of 4 syringes, administered every 1.25 minutes per syringe.

Other: Cryotherapy

Rountine pulpotomy

NO INTERVENTION

After hemostasis is achieved, the pulpotomy area is irrigated for 5 minutes with normal saline solution, which is kept in the room temperature 25°C (measuring with thermometer and record) by using a disposable insulated 5 ml syringe and 21-gauge needle is placed 1-2 mm above the root canal orifices and is constantly moved in a circular motion.

Interventions

Cryotherapy OTHER

After hemostasis is achieved, the pulpotomy area is irrigated for 5 minutes with normal saline solution, which is kept in the refrigerator set to 2.5°C (measuring with thermometer and record) by using a disposable insulated 5 ml syringe and 21-gauge needle is placed 1-2 mm above the root canal orifices and is constantly moved in a circular motion: 5 ml in each of 4 syringes, administered every 1.25 minutes per syringe.

Addition of Cryotherapy on pulpotomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 within the previous 24 hours.
• Patients taking opioids.
• Known allergies to non-steroidal anti-inflammatory drugs (NSAIDs).
• Pregnant or lactating patients.
• Teeth with pulpal obliteration.
• Necrotic pulp is found after access opening.
• Bleed cannot be stopped within 8 minutes after full pulpotomy

Sponsors & Collaborators

• Sirawut Hiran-us: lead
• Chulalongkorn University: collaborator

Study Sites (1)

Yala Hospital

Yala, 95000, Thailand

Location

Related Publications (1)

• Gurler K, Yilmaz K. The Effect of Novel Cryotherapy Technique on Postoperative Pain for Pulpotomy in Permanent Molars with Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial. J Endod. 2025 May;51(5):547-553. doi: 10.1016/j.joen.2025.01.020. Epub 2025 Feb 3.

  PMID: 39909197 RESULT

MeSH Terms

Interventions

Cryotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Sirawut Hiran-us, DDS, MSc, High Grad Dip, FRCDS

  Faculty of Dentistry, Chulalongkorn University

  STUDY DIRECTOR

• Sawat Pojlerdarun, DDS, Higher Grad Dip, FRCDS

  Dental Department, Yala Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: January 21, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

TH (1)