NCT06918639 Effectiveness of Pulpotomy in Symptomatic Permanent Teeth With Deep Caries Lesions
| NCT ID | NCT06918639 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidad Rey Juan Carlos |
| Condition | Irreversible Pulpitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-04-11 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2024-04-11 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Preservation of pulp tissue would allow it to continue to exert its defensive and physiological functions and more tooth tissue would be preserved, leading to less weakening of the tooth. In addition, root canal treatment is a more complex therapeutic process that requires the use of more instruments, more time and more visits. To date, most clinical studies that have evaluated the success of pulpotomy treatments have been conducted on teeth with immature apexes. More studies are needed to evaluate VPT success in the permanent dentition in the long term. In accordance with the above, the main objective of the study will be to determine the success of partial or total pulpotomy treatment in permanent teeth (\>18 adults) with a closed apex and symptoms compatible with irreversible pulpitis. At the same time, the association of factors related to the patient, the treated tooth and specific treatment factors with the success of pulpotomies will be determined. On the other hand, the patient, perception and satisfaction with the treatment received will be evaluated. All treatments (pulpotomies and restorations) will be carried out by the principal investigator. After recording the preoperative data, clinical and radiographic examination, a diagnosis will be made according to the classification of Wolters and collaborators , which will also guide us in the choice of pulp treatment: PP o CP Partial pulpotomy or complete pulpotomy. The maximum pulp haemostasis time will be 10 minutes. In both treatments, in the same appointment, the definitive restoration of the tooth will be carried out. The evaluations will be performed at one week, 3 , 6 and 12 months postoperatively. This evaluation shall be performed by an examiner who shall be different from the one performing the treatment. The main outcome of the present study will be the determination of the success of the pulpotomies. \- Is vital pulp therapy a highly successful treatment for teeth with irreversible pulpitis?. Outcome measure 1: Success rate of vital pulp therapy \- Do patients feel satisfied with this conservative pulp treatment? Outcome measure 2: Patient´s satisfaction with vital pulp therapy
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.
Contact & Investigator
Laura Ceballos, Full Professor, DDS, PhD
STUDY DIRECTOR
Universidad Rey Juan Carlos
Frequently Asked Questions
Who can join the NCT06918639 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Irreversible Pulpitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06918639 currently recruiting?
Yes, NCT06918639 is actively recruiting participants. Contact the research team at olga.gonzalez.castro@clinica.urjc.es for enrollment information.
Where is the NCT06918639 trial being conducted?
This trial is being conducted at Alcorcón, Spain.
Who is sponsoring the NCT06918639 clinical trial?
NCT06918639 is sponsored by Universidad Rey Juan Carlos. The principal investigator is Laura Ceballos, Full Professor, DDS, PhD at Universidad Rey Juan Carlos. The trial plans to enroll 50 participants.