The Effect of Cryotherapy on Treatment Outcomes for Pulpotomy

NCT07303010 | Not Yet Recruiting Early Phase 1

• 1 other identifier: BBC 33/2025
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate the effect of cryotherapy on treatment outcome for pulpotomny in permanent mature carious posterior teeth. The main question is: Do cryotherapy improve treatment outcome in interested samples? \[primary hypothesis or outcome measure 1\] Treatment outcome by clinical and radiographic examination. Treatment outcome from different groups will be compared at designated time points.

Conditions

Carious Teeth

Keywords

pulpotomy; cryotherapy

Outcome Measures

Primary Outcomes (1)

• Treatment outcome of pulpotomy

  Determine the treatment outcome in to success or failure Success: No clinical sign and symptom and no abnormality of periapical tissue from radiograph Failure: Presence of any clinical sign or symptom or abnormality of periapical tissue from radiograph

  The outcomes will be evaluated as healed, healing or disease at one year after completion of treatment and annually thereafter for up to ten years, or until the patient is no longer available for follow-up.

Study Arms (2)

Addition of Cryotherapy on pulpotomy

EXPERIMENTAL

Experimental: Addition of Cryotherapy on pulpotomy 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: Addition of Cryotherapy on pulpotomy

Rountine pulpotomy

NO INTERVENTION

No Intervention: Rountine pulpotomy

Interventions

Addition of Cryotherapy on pulpotomy OTHER

Experimental: Addition of Cryotherapy on pulpotomy 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: Yes
• 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 asymptomatic or 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).
• 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.
• 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

Study Sites (1)

Yala Hospital

Yala, 95000, Thailand

Location

Related Publications (1)

• Taha NA, Albakri SW. Outcome and Prognostic Factors for Partial and Full Pulpotomy in the Management of Spontaneous Symptomatic Pulpitis in Carious Mature Permanent Teeth: A Randomized Clinical Trial. J Endod. 2024 Jul;50(7):889-898. doi: 10.1016/j.joen.2024.03.012. Epub 2024 Apr 5.

  PMID: 38583758 RESULT

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

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

  Yala Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

66 812055775; sirawut.h@chula.ac.th

Sawat Pojlerdarun, DDS, Higher Grad Dip, FRCDS

CONTACT

66 828955635; lookbadz@hotmail.com

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 Orofessor

Study Record Dates

• First Submitted: December 6, 2025
• First Posted: December 24, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): December 30, 2035
• Study Completion (Estimated): December 30, 2035
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

TH (1)