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

NCT ID: NCT05199181

Last Updated: 2022-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-19
• Study Completion Date: 2021-03-30

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.

Conditions

Symptomatic Irreversible Pulpitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Full pulpotomy

All patients were treated in one visit (with Full Pulpotomy); the previously trained General Practice Dentist performed all the clinical procedures

Group Type: EXPERIMENTAL

Full pulpotomy

Intervention Type: PROCEDURE

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.

Interventions

Full pulpotomy

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.

Intervention Type: PROCEDURE

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.

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

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rubén Domínguez Pérez

OTHER

Sponsor Role: lead

Responsible Party

Rubén Domínguez Pérez

Head of department Multidisciplinary Dentistry Research

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Roberto Sanchez-Lara y Tajonar, DDS, Endod

Role: STUDY_DIRECTOR

Universidad Autónoma de Querétaro

Locations

Centro de Salud -La Negreta- Jurisdicción Sanitaria 1 del Estado de Querétaro

Querétaro, , Mexico

Countries

Mexico

Other Identifiers

JS1/ENS/215/220

Identifier Type: -

Identifier Source: org_study_id