Actively Recruiting
Discovering Prognostic Biomarkers for Pulpotomy Outcome in Permanent Mature Teeth With Irreversible Pulpitis
Led by The University of Hong Kong · Updated on 2024-07-23
192
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating treatments for permanent mature molars diagnosed with irreversible pulpitis, a painful dental condition. The study aims to identify biomarkers that can predict the outcome of pulpotomy, a dental procedure removing diseased pulp tissue. It compares the long-term success of full pulpotomy with root canal treatment (RCT) over a two-year period, using blood and tissue samples to study inflammation and cellular activity. Participants will receive either full pulpotomy, where the entire roof of the pulp chamber and pulp tissue are removed and covered with Biodentine before restoring the tooth with resin-based composite, or root canal treatment as a control. Blood samples and pulp tissues will be collected during treatment for detailed analysis including histology, spatial imaging, and single-cell RNA sequencing. Pulpotomy outcomes will be assessed clinically and with radiographs at 6 and 12 months, while the comparison with RCT outcomes will occur at 24 months. During the study, researchers will monitor treatment success and failure by analyzing biomarkers in blood and tissue samples and correlating these with clinical outcomes. Participants will undergo evaluations at specific intervals to track healing and treatment effectiveness. The study includes 180 molars: 120 treated with pulpotomy and 60 with RCT, plus samples from healthy teeth as controls. This research spans two years, with outcomes measured at multiple time points to better understand and improve treatment for irreversible pulpitis.
CONDITIONS
Brief Title
Prognostic Biomarkers for Pulpotomy Outcome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Permanent molars with a deep cavity extending close to the pulp chamber
- Clinical diagnosis of irreversible pulpitis including spontaneous or lingering pain
- Positive response to cold and electric pulp tests
You will not qualify if you...
- Teeth with no response to cold and electric tests or signs of advanced damage like apical radiolucency or resorption
- Teeth with history of trauma, unrestorable or nonfunctional teeth, or perio-endo lesions
- Intraoperative bleeding lasting more than 10 minutes or insufficient pulpal blood sample
- Patients with compromised immune status or recent use of antibiotics or painkillers within one week
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single treatment visit with long-term follow-up
Participants receive either a full pulpotomy or root canal treatment for irreversible pulpitis.
1 treatment visit (in-person)
Duration - 2 years
Participants are monitored to assess the success of the treatment and biomarker outcomes over 2 years.
Periodic visits during 2 years for outcome assessments
Trial Site Locations
Total: 1 location
1
Clinical Research Centre, Faculty of Dentistry, The University of Hong Kong
Hong Kong, Hong Kong
Actively Recruiting
Research Team
R
Rong Cen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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