Patient Perception Between Two Emergency Treatments of Symptomatic Irreversible Pulpitis.

Aula Dental Avanzada

Status

Completed

Conditions

Irreversible Pulpitis

Treatments

Procedure: Pulpotomy

Procedure: Pulpectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT04654845

PULP

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

20 to 100 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Patient in American Society of Anesthesiologists I or II condition.
Patient who comes to the emergency room with irreversible pulpitis in a single tooth.
Patients of age >20 years.
Positive response to the vitality test and bleeding after pulp exposure.

Exclusion criteria

American Society of Anesthesiologists patients>II.
Pharmacological allergies that contraindicate the intervention.
Teeth with negative vitality test and no bleeding after pulp exposure.
Signs of concomitant periodontal infection such as swelling or fistula.
Teeth with immature roots.
Patients who are medicated with anxiolytics.
Abuse of psychotropic drugs or medication that may alter the perception of pain 15 days before the intervention.
Pregnant or breast-feeding women.
Interventions with conscious sedation.
Pathological mental state (dementia, psychosis).
Lack of collaboration or non-acceptance of the consent of the study.