Comparing full pulpotomy and root canal treatment for irreversible pulpitis
Full Pulpotomy Versus Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis: A Clinical Study
This study is testing whether a less invasive tooth treatment called full pulpotomy works better than traditional root canal treatment for adults with painful tooth issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | University of Malaya Academic / other |
| Locations | 1 site (Kuala Lumpur) |
| Trial ID | NCT06002698 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of full pulpotomy versus traditional root canal treatment in adults with symptomatic irreversible pulpitis in their posterior teeth. It will involve a randomized controlled design to assess outcomes related to pain relief and tooth preservation. Additionally, the study will evaluate the cost-effectiveness of pulpotomy and gather feedback from both dentists and patients regarding the acceptability of the treatment options. The trial seeks to provide robust evidence to inform clinical practice in endodontics.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 12 years or older with a mature posterior tooth showing signs of irreversible pulpitis and capable of being treated with either pulpotomy or root canal therapy.
Not a fit: Patients with active periodontal disease, apical periodontitis, or complex medical histories that may affect treatment outcomes are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from irreversible pulpitis, potentially preserving more teeth and reducing the need for more invasive procedures.
How similar studies have performed: Other studies have suggested the potential benefits of vital pulp treatment approaches, but this specific comparison of full pulpotomy and root canal treatment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 12 years or older (with a mature permanent tooth demonstrating radiographic evidence of a deep caries/restorations and signs/ symptoms indicative of IRP (moderate to severe spontaneous lingering pain). Tooth will be responsive to cold and EPT sensibility testing, restorable and can be adequately isolated during treatment. One posterior tooth (molar or premolar) only per patient. Exclusion Criteria: * Teeth with active periodontal disease (pocket depth \>5mm); teeth indicated for elective root canal treatment for restorative purposes, teeth with apical periodontitis, patients with complex medical histories that may affect their caries experience and healing ability (immunocompromised, radiotherapy), patients who are unable to consent; history of previous trauma to the tooth, presence of apical radiolucency and patients who are pregnant or breast-feeding. Intraoperatively, any evidence of purulence or excessive bleeding that cannot be controlled with a cotton pellet with 2-4% hypochlorite for 10 minutes will be excluded.
Where this trial is running
Kuala Lumpur
- Hany Mohamed Aly Ahmed — Kuala Lumpur, Malaysia (Recruiting)
Study contacts
- Principal investigator: Hany Ahmed, PhD — University of Malaya
- Study coordinator: Hany Ahmed, PhD
- Email: hanyendodontist@um.edu.my
- Phone: 0060129857937
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.