Clinical trial NCT05199181: Full Pulpotomy in Mature Teeth With Symptomatic Irreversible Pulpitis as a Routine Treatment in the Primary Care Clinics
Official title: An Approach Feasibility Study to Establish Full Pulpotomy in Mature Teeth With Symptomatic Irreversible Pulpitis as a Routine Treatment in the Primary Care Dental Clinics of the Public Health System in Mexico
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Symptomatic Irreversible Pulpitis
Keywords: symptomatic irreversible pulpitis
full pulpotomy
mature teeth
Lead sponsor: Universidad Autónoma de Querétaro
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 41
Sex: ALL
Minimum age (years): 17
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Longitudinal prospective single-arm cohort clinical study
Primary purpose: TREATMENT

Brief summary: The present study has the objective of being a first approach of the full feasibility study in order to find out whether the Full Pulpotomy performed by a general practice dentist in a primary care dental clinic at the public health system with limited armamentarium could be suitable and present an appropriate success rate as well as patient satisfaction.

Detailed description: The present study has the objective of being a first approach of the full feasibility study in order to find out whether the Full Pulpotomy performed by a general practice dentist in a primary care dental clinic at the public health system with limited armamentarium could be suitable and present an appropriate success rate as well as patient satisfaction. This information will help to decide if a multi-center non-randomized intervention designed study is carried out to determine if it is feasible to provide Full Pulpotomy as a routine treatment to symptomatic irreversible pulpitis or caries pulp exposure at the primary care dental clinics of the public health system in Mexico.

Eligibility criteria: Inclusion Criteria:

All the patients attending the primary care dental clinic with deep caries and/or pain in a permanent premolar or molar tooth.

* Teeth with complete radicular growth.
* Preoperative symptoms of irreversible pulpitis (Spontaneous pain or exacerbated by thermal stimuli and lasting for a few seconds to several hours interpreted as lingering pain compared with a control tooth and that could be reproduced using thermal testing)

Exclusion Criteria:

Medically comprised or pregnant patients.

* Teeth exclusion criteria:
* Pathological mobility
* Sinus tract
* Teeth that cannot be restored with amalgam
* Radiographic internal or external resorption
* Presence of apical rarefaction

Primary outcomes:
measure: Treatment success rate
timeFrame: 1 Month follow-up
measure: Treatment success rate
timeFrame: 3 Months follow-up
measure: Treatment success rate
timeFrame: 6 Months follow-up
measure: Treatment success rate
timeFrame: 9 Months follow-up
measure: Treatment success rate
timeFrame: 12 Months follow-up
Secondary outcomes:
measure: Satisfaction with the effect of the treatment
timeFrame: 24 Hours
Other outcomes:
Locations:
city: Querétaro
country: Mexico
facility: Centro de Salud -La Negreta- Jurisdicción Sanitaria 1 del Estado de Querétaro
Study officials:
affiliation: Universidad Autónoma de Querétaro
name: Roberto Sanchez-Lara y Tajonar, DDS, Endod
role: STUDY_DIRECTOR
References: