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

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.

Study Overview

• Status: Completed
• Conditions: Symptomatic Irreversible Pulpitis
• Intervention / Treatment: Procedure: Full pulpotomy

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Querétaro, Mexico, 76138
    • Centro de Salud -La Negreta- Jurisdicción Sanitaria 1 del Estado de Querétaro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment success rate	To 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	1 Month follow-up
Treatment success rate	To be considered successful, none of the following symptoms had to be present at three months 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	3 Months follow-up
Treatment success rate	To be considered successful, none of the following symptoms had to be present at six months 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	6 Months follow-up
Treatment success rate	To be considered successful, none of the following symptoms had to be present at nine months 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	9 Months follow-up
Treatment success rate	To be considered successful, none of the following symptoms had to be present at 12 months 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	12 Months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with the effect of the treatment	Patients 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".	24 Hours

Collaborators and Investigators

• Sponsor: Rubén Domínguez Pérez
• Investigators: Study Director: Roberto Sanchez-Lara y Tajonar, DDS, Endod, Universidad Autónoma de Querétaro

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2019
• Primary Completion (Actual): March 20, 2020
• Study Completion (Actual): March 30, 2021

Study Registration Dates

• First Submitted: January 3, 2022
• First Submitted That Met QC Criteria: January 14, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): January 20, 2022
• Last Update Submitted That Met QC Criteria: January 14, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: symptomatic irreversible pulpitis; full pulpotomy; mature teeth
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis
• Other Study ID Numbers: JS1/ENS/215/220

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No