NCT07388862

Brief Summary

The goal of this \[randomized clinical trial\] is to evaluate the treatment outcome by assessing clinical and radiographic outcomes. The main question it aims to answer is Do using dental operating microscope incorperated with pulpotomy procedure will have a different outcome when compare with without using. Participants will be asked to have clinical and radiographic evaluation for evaluating the outcome every year after treatment.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for early_phase_1

Timeline
141mo left

Started Feb 2026

Longer than P75 for early_phase_1

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Feb 2026Dec 2037

First Submitted

Initial submission to the registry

January 21, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

February 21, 2026

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2036

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2037

Last Updated

March 18, 2026

Status Verified

January 1, 2026

Enrollment Period

10.9 years

First QC Date

January 21, 2026

Last Update Submit

March 16, 2026

Conditions

Irreversible Pulpitis

Keywords

Pulpotomytreatment outcomedental operating microscope

Outcome Measures

Primary Outcomes (1)

  • Treatment outcome

    Treatment outcomes will be classified as healed, healing, or failure based on clinical and radiographic evaluations. Healed: Cases presenting with no clinical symptoms and no evidence of a periapical lesion on radiographic examination. Healing: Cases presenting with no clinical symptoms and a reduction in the size of the periapical lesion on radiographic examination. Failure: Cases presenting with clinical symptoms and/or enlargement of the periapical lesion on radiographic examination.

    Yearly up to 10 years

Study Arms (2)

Additional using of dental operating microscope in the procedure

EXPERIMENTAL

using of dental operating microscope (OPMI PICO, Carl Zeiss) in the procedure for improving the quality of treatment

Device: Dental operating microscope

Routine pulpotomy

NO INTERVENTION

Routine pulpotomy procedure without addition using of dental operating microscope

Interventions

Dental operating microscopeDEVICE

Incorperating the using of dental operating microscope into the pulpotomy procedure

Additional using of dental operating microscope in the procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 teeth diagnose with asymptomatic or symptomatic irreversible pulpitis. Diagnoses are confirmed using EPT and cold tests. Pulpal and periapical diagnoses are based on terminology from the American Association of Endodontists (AAE, 2013)20.
  • 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.
  • Teeth with pulpal obliteration.
  • Necrotic pulp is found after access opening
  • Bleed cannot be stopped within 8 minutes after full pulpotomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Sirawut Hiran-us

    Faculty of Dentistry, Chulalongkorn University

    STUDY DIRECTOR

  • Choontawee Soponsakulkaew

    Phaholponpayuhasena Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

66 812055775sirawut.h@chula.ac.th

Choontawee Soponsakulkaew, DDS, Higher Grad Dip, FRCDS

CONTACT

66 982693303choontaweeso@gmail.com

Study Design

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

Study Record Dates

First Submitted

January 21, 2026

First Posted

February 5, 2026

Study Start

February 21, 2026

Primary Completion (Estimated)

December 31, 2036

Study Completion (Estimated)

December 31, 2037

Last Updated

March 18, 2026

Record last verified: 2026-01