Patient Perception Between Two Emergency Treatments of Symptomatic Irreversible Pulpitis.
Condition: Irreversible Pulpitis
MeSH terms: Pulpitis; Emergencies
Study type: Interventional

Summary: 
      To evaluate in a comparative way the perception of the patient who comes with pain due to
      irreversible pulpitis in a tooth and who receives two types of treatment: complete pulpectomy
      (or control group) or pulpotomy (or experimental group).

      Prospective randomized and multicenter study. It will be carried out in 4 centers of similar
      socio-professional characteristics, with the same operative protocol. On a significant sample
      of emergency patients with a concrete clinical manifestation of symptomatic irreversible
      pulpitis, one type of intervention or another will be performed randomly. The data will be
      collected by means of a visual numeric scale (NRS).

      The null hypothesis is that both interventions provide the same reduction of pain in patients
      who present symptomatic irreversible pulpitis.

      All the patients who come to one of the private centers with irreversible pulpitis and who
      meet the defined criteria for inclusion and exclusion will be selected.

      The type of procedure that will be performed in the control group will be the complete
      removal of the pulp by means of a defined instrumentation technique, also called Pulpectomy.
      The procedure to be performed in the experimental group will be the removal of the pulp only
      at coronal level, also called Pulpotomy. The interventions will be assigned randomly and the
      "List Randomizer" (random.org) will be used for the randomization.
    

Detailed description: 
      Clinical procedure will be the same in both groups with regard to the anesthetic technique,
      and the cavity access and provisional closure of the aperture. The characteristics of both
      interventions will be described in detail in order to homogenize the procedures. The patient
      will be conveniently informed before requesting his/her Informed Consent for his/her
      voluntary participation in the study. Their identification data will be treated in accordance
      with the provisions of Regulation (EU) 2016/679 of the European Parliament and Council of
      April 27, 2016, and the Organic Law 3/2018 of 5/12, currently in force, will remain in
      custody at the Center where they receive treatment and will not be shared by the other
      centers of the study.

      The patient will not be aware of the type of procedure he has been assigned for and will
      express in a numerical scale according to his perception of the pain on 4 occasions: before
      starting treatment, at 8-12, 24 and 72 hours after treatment. Likewise, right after receiving
      the treatment, he will answer some questions related to the degree of comfort during the
      treatment and about his perception of the time of the intervention.

      Data sheets will be collected and treated statistically.
    

Intervention name(s): Pulpotomy; Pulpectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Access to pulp chamber. Removal of the pulp chamber tissue. Use of Sodium Hypochlorite (5.25% NaCl) during the whole procedure and in the amount considered appropriate by each operator.
Wait until confirmation of absence of bleeding from the conducts. Placement of polytetrafluroethylene in pulp chamber. Placement of temporary filling. Reduction of the occlusal surface of the tooth until there is no contact with the articulating paper from 200μ.; Access to pulp chamber. Removal of the pulp chamber tissue. Use of Sodium Hypochlorite (5.25% NaCl) during the whole procedure and in the amount considered appropriate by each operator.
Establishment of working length by means of Electronic Apex Locator and a number 8 K file.
Access to all conducts with a number 10 K file. Rotary instrumentation with one reciprocating system up to working length and up to an apical diameter of 25.
Placement of polytetrafluroethylene in pulp chamber. No intermediate medication will be filled into the conducts.
Placement of temporary filling. Reduction of the occlusal surface of the tooth until there is no contact with the articulating paper from 200μ.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants with irreversible pulpitis are randomly assigned to one type of intervention.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Pulpotomy; Pulpectomy