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Patient Perception Between Two Emergency Treatments of Symptomatic Irreversible Pulpitis.

NCT04654845 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-08-11

No results posted yet for this study

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.

Conditions

  • Irreversible Pulpitis

Interventions

PROCEDURE

Pulpotomy

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.

PROCEDURE

Pulpectomy

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.

Sponsors & Collaborators

  • Aula Dental Avanzada

    lead OTHER

Principal Investigators

  • Guillem Esteve-Pardo, DDS · Aula Dental Avanzada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-16
Primary Completion
2022-07-29
Completion
2022-07-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04654845 on ClinicalTrials.gov