Evaluating biomarkers for the outcome of pulpotomy in molars with irreversible pulpitis
Discovering Prognostic Biomarkers for Pulpotomy Outcome in Permanent Mature Teeth With Irreversible Pulpitis
This study is testing whether a full pulpotomy can work better than root canal treatment for molars with irreversible pulpitis by looking at inflammation markers and checking how well the treatments perform over time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 192 (estimated) |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06514053 on ClinicalTrials.gov |
What this trial studies
This study aims to recruit 180 molars diagnosed with irreversible pulpitis to assess the outcomes of full pulpotomy compared to root canal treatment. A total of 120 teeth will undergo pulpotomy, while 60 will receive root canal treatment as a control. Blood samples and pulp tissues will be collected for analysis to profile inflammation-related biomarkers. The treatment outcomes will be evaluated clinically and radiographically at 6 and 12 months post-treatment.
Who should consider this trial
Good fit: Ideal candidates include patients with permanent molars exhibiting clinical signs of irreversible pulpitis and deep carious lesions.
Not a fit: Patients with apical radiolucency, non-responsive teeth, or those with compromised immune systems may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for irreversible pulpitis, enhancing patient outcomes.
How similar studies have performed: While there may be studies on pulpotomy and root canal treatments, this specific approach focusing on biomarkers is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hong Kong
- Clinical Research Centre, Faculty of Dentistry, The University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Chengfei Zhang — The University of Hong Kong
- Study coordinator: Rong Cen
- Email: cenrong@hku.hk
- Phone: +852 28590290
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.