Evaluating the effectiveness of pulpotomy for treating deep caries in permanent teeth
Effectiveness of Pulpotomy in Symptomatic Permanent Teeth With Deep Caries Lesions
This study is testing how well pulpotomy treatments work for adults with deep tooth decay to see if they can keep their teeth healthy and pain-free.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universidad Rey Juan Carlos Academic / other |
| Locations | 1 site (Alcorcón, Madrid) |
| Trial ID | NCT06918639 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the success of partial or total pulpotomy treatments in permanent teeth with irreversible pulpitis in adults over 18 years old. The study will focus on factors related to the patient, the treated tooth, and specific treatment methods to determine their association with the success of pulpotomy. Success will be defined by the absence of symptoms and maintenance of pulp vitality, with patient satisfaction recorded through surveys after the procedure. The study addresses a gap in existing research by evaluating pulpotomy outcomes in teeth with closed apexes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with symptomatic irreversible pulpitis in permanent teeth that can be treated with pulpotomy.
Not a fit: Patients with pulp necrosis, abscesses, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive treatment option for patients with deep caries, preserving more tooth structure and reducing the need for complex root canal procedures.
How similar studies have performed: While there have been studies on pulpotomy in immature teeth, this study's focus on permanent teeth with closed apexes is relatively novel and underexplored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients over 18 years of age. * Patients in good general health, ASA I or ASA II with no contraindications to contraindications to receive a TPV procedure under local anaesthesia. * Tooth with symptomatology of pulpitis, both reversible and irreversible, to be determined by history of spontaneous pain, exacerbation of pain with heat and cold confirmed by the cold test and radiating pain. * Tooth without signs of pulp necrosis and absence of sinus tract and abscess. * Tooth in occlusion with antagonist tooth and without discomfort on chewing. * Tooth that can be directly restored. * Tooth with pocket depth and mobility within normal limits. * Extent of the caries lesion greater than two thirds of the amelodentine distance or which tooth or the pulp has been exposed during caries removal. Exclusion Criteria: * Patients with allergies or intolerance to any anaesthetic solution. * Pregnant patients or patients who suspect pregnancy due to the impossibility of complementary radiographic tests cannot be carried out. * Patients with systemic pathology that prevents the use of a vasoconstrictor or with a compromised immune system that may influence the response to treatment. * Tooth with an immature apex. * Tooth that is not restorable or not viable for preservation. * Tooth with negative response to thermal sensitivity test or electrical test. * Tooth in which haemostasis cannot be achieved after exposure of the pulp, or with a pulp, or with a haemostasis time exceeding 10 minutes, where there is no pulp bleeding or partial or complete tissue necrosis is observed.
Where this trial is running
Alcorcón, Madrid
- Rey Juan Carlos University — Alcorcón, Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Olga González-Castro, Dds
- Email: olga.gonzalez.castro@clinica.urjc.es
- Phone: +34667938051
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.