Comparison of Postoperative Pain After Pulpotomy Performed With Versus Without Dental Operating Microscope in Carious Mature Permanent Teeth

NCT07373977 | Not Yet Recruiting Early Phase 1

• 1 other identifier: BBC 42/2025
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this \[randomized clinical trials\] is to investigate the effect of using dental operating microscope incorperated in full pulpotomy procedure in mature carious posterior teeth. The main questions it aims to answer are: investigate postoperative pain levels. investigate the quality of life of patient after treatment. If there is a comparison group: Researchers will compare the pulpotomy procedure with and without using dental operating microscope. Participants will will be asked to do

• Pain evaluation with numerical rating scale
• OHIP 14 survey before and after treatment

Conditions

Carious Exposure of Pulp

Keywords

Pulpotomy; Dental operating microscope; post-operative pain

Outcome Measures

Primary Outcomes (1)

• Post-operative pain

  Patient will be asked to do a post-operative pain assessment by using numerical rating scale before and after treatment a 6hr, 24 hrs, 48 hrs, 72 hrs. Minimum is 0, Maximum is 10 Higher the score worsen the outcome.

  72 hrs after treatment

Secondary Outcomes (1)

• Patient's quality of life assessment

  72 hrs after treatment

Study Arms (2)

Additional using of dental operating microscope in the procedure

EXPERIMENTAL

using of dental operating microscope in the procedure to improve the quality of treatment

Device: Using dental operating microscope

Rountine pulpotomy

NO INTERVENTION

Rountine pulpotomy procedure without addition using of dental operating microscope

Interventions

Using dental operating microscope DEVICE

Using dental operating microscope additional to the procedure

Additional using of dental operating microscope in the procedure

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 teeth diagnose with 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.
• Posterior teeth with moderate or severe pain according to The NRS (Numeric Rating Scale) According to this scale, the level of pain is documented in the range of 0-10 numerically and verbally as no pain (0), mild pain, non-disruptive to routine activities (1-3), moderate pain that interferes with daily life but no need analgesics intake (4-6) and severe pain that significantly disrupts normal acitivities requiring analgesic intervention (7-10).
• Teeth that response negatively to percussion and palpation tests.
• 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. If necessary, record how many and dose that taken.
• 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

• Chulalongkorn University: lead

Related Publications (1)

• Chang Ya-Ching, Wang Ting-Ya, Effectiveness of microscope-assisted root canal treatment in permanent posterior teeth: A retrospective cohort study. Journal of Dentistry, 2025.157: 105771.

  BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

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

  Faculty of Dentistry, Chulalongkorn University

  STUDY DIRECTOR

• Choontawee Soponsakulkaew, DDS, Higher Grad Dip, FRCDS

  Phaholpolpayuhasena Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

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

Choontawee Soponsakulkaew, DDS, Higher Grad Dip, FRCDS

CONTACT

66 982693303; choontaweeso@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: January 28, 2026
• Study Start: February 10, 2026
• Primary Completion (Estimated): December 28, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01