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Full Pulpotomy in Mature Teeth With Symptomatic Irreversible Pulpitis as a Routine Treatment in the Primary Care Clinics

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05199181
Enrollment
41
Registered
2022-01-20
Start date
2019-11-19
Completion date
2021-03-30
Last updated
2022-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptomatic Irreversible Pulpitis

Keywords

symptomatic irreversible pulpitis, full pulpotomy, mature teeth

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.

Interventions

After applying the rubber dam. Caries, and weak tissues were removed, and the endodontic access was prepared with a carbide bur. Most of the pulp was removed with a sterile high-speed diamond bur under sterile saline solution irrigation and amputated to the canal orifices level. Hemostasis was achieved by irrigation of the cavity with the same solution and an application of small cotton pellets for max.10 min. White Mineral Trioxide Aggregate was mixed according to the manufacturer´s instructions and was placed against the wound after successful hemostasis using an amalgam carrier and packed using an amalgam standard condenser. The material was adapted and a moistened cotton pellet was placed directly over the Mineral Trioxide Aggregate. After 15 minutes, the cotton was removed and the tooth was restored with amalgam. A postoperative radiograph was taken after restoration, general care instructions were given to the patients, and the recommendation of three analgesic intakes.

Sponsors

Rubén Domínguez Pérez
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Longitudinal prospective single-arm cohort clinical study

Eligibility

Sex/Gender
ALL
Age
17 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Treatment success rate1 Month follow-upTo be considered successful, none of the following symptoms had to be present at one month follow-up: persistent pain, exaggerated tenderness to percussion, pathologic mobility, swelling, sinus track related to the treated tooth, evidence of periradicular radiolucency, furcal pathosis, or root resorption

Secondary

MeasureTime frameDescription
Satisfaction with the effect of the treatment24 HoursPatients were contacted by phone to record the satisfaction with the effect of the treatment. The possible answers for their satisfaction level were: Very satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied, or Very dissatisfied.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026