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Search / Trial NCT06918639

Effectiveness of Pulpotomy in Symptomatic Permanent Teeth With Deep Caries Lesions

Launched by UNIVERSIDAD REY JUAN CARLOS · Apr 6, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Pulpotomy Vitalpulptherapy Partialpulpotomy Biodentinexp Fullpulpotomy Completepulpotomy

ClinConnect Summary

This clinical trial is investigating how effective a treatment called pulpotomy is for adults with certain dental problems, specifically those with deep cavities and symptoms of irreversible pulpitis, which means the tooth's nerve is inflamed and can't heal on its own. The goal is to see if removing part or all of the pulp tissue (the soft center of the tooth) can help save the tooth and allow it to function normally, while also being a simpler and less time-consuming option compared to traditional root canal treatment. Researchers will also look at how satisfied patients are with this treatment.

To be eligible for the trial, participants must be over 18 years old and in good health, with a tooth that shows signs of pulp inflammation but is still restorable. This means no major issues like tooth death or infection. During the study, participants will receive the pulpotomy treatment and a final restoration in one appointment, and they will have follow-up evaluations at one week, three months, six months, and one year after the procedure to check on the tooth's health and their satisfaction with the treatment.

Gender

ALL

Eligibility 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.

About Universidad Rey Juan Carlos

Universidad Rey Juan Carlos (URJC) is a prominent academic institution located in Madrid, Spain, dedicated to advancing knowledge and research in various fields, including health sciences. With a commitment to innovation and excellence, URJC actively engages in clinical trials aimed at improving patient care and outcomes. The university's multidisciplinary approach fosters collaboration among researchers, clinicians, and industry partners, ensuring that its clinical research is grounded in scientific rigor and ethical standards. Through its robust infrastructure and expertise, Universidad Rey Juan Carlos is poised to contribute significantly to the advancement of medical research and the development of novel therapeutic interventions.

Locations

Alcorcón, Madrid, Spain

Patients applied

0 patients applied

Trial Officials

Laura Ceballos, Full Professor, DDS, PhD

Study Director

Universidad Rey Juan Carlos

Victoria Fuentes, Associate Professor, DDS, PhD

Study Director

Universidad Rey Juan Carlos

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported