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Search / Trial NCT06514053

Prognostic Biomarkers for Pulpotomy Outcome

Launched by THE UNIVERSITY OF HONG KONG · Jul 20, 2024

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the outcomes of two different treatments for permanent molars that have a serious condition called irreversible pulpitis, which means the pulp inside the tooth is inflamed and damaged. The trial will include 180 molars, with 120 receiving a procedure called full pulpotomy, where the damaged pulp is removed, and 60 teeth undergoing root canal treatment as a comparison. Researchers will also collect blood and tissue samples from healthy teeth to help understand the healing process better. Over the course of the study, which will last up to two years, they will examine how well each treatment works by looking at clinical signs and taking X-rays at 6 and 12 months, and comparing treatment success rates after one year.

To be eligible for this trial, participants should have permanent molars with severe cavities that are close to the pulp, along with specific symptoms such as pain when exposed to cold. However, people with certain conditions, like a compromised immune system or specific tooth issues, will not be included. If you decide to participate, you can expect to receive one of the two treatments and will be closely monitored for your recovery. This study aims to find out which treatment offers better long-term results and to identify important indicators of treatment success.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Permanent molars showing clinical and radiographic evidence of a deep carious lesion (extend to the three-quarters thickness of dentine radiographically) extending close to the pulp chamber
  • Clinical diagnosis of irreversible pulpitis, including spontaneous pain, lingering pain with cold stimulation, no or mild tenderness to percussion, normal apical tissue or widening of the periodontal ligament space but with no signs of periapical periodontitis (i.e., PAI score 1 or 2)
  • Positive response to cold and electric pulp test.
  • Exclusion Criteria:
  • Tooth with no response to the cold and electric tests, presence of apical radiolucency (greater than periodontal widening), signs of canal calcification and resorption, history of trauma, unrestorable or nonfunctional teeth, and evidence of perio-endo lesion
  • Intraoperative bleeding time is more than 10 minutes or less than 10 μL pulpal blood can be obtained
  • Patients with a compromised immune status (such as HIV or organ transplant) or with any history of taking analgesics/antibiotics in the past one week.

About The University Of Hong Kong

The University of Hong Kong (HKU) is a leading research institution dedicated to advancing medical knowledge and improving healthcare outcomes through innovative clinical trials. With a commitment to excellence in research and education, HKU collaborates with various stakeholders, including healthcare providers and industry partners, to conduct rigorous and ethically sound clinical studies. The university's diverse expertise and state-of-the-art facilities enable it to explore a wide range of therapeutic areas, contributing to the global pursuit of scientific advancement and the development of novel treatment strategies.

Locations

Hong Kong, , Hong Kong

Patients applied

0 patients applied

Trial Officials

Chengfei Zhang

Principal Investigator

The University of Hong Kong

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported