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

Symptomatic Irreversible Pulpitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05199181
• Other study ID #: JS1/ENS/215/220
• Status: Completed
• Phase: N/A
• Start date: November 19, 2019
• Est. completion date: March 30, 2021

Study information

• Verified date: January 2022
• Source: Universidad Autónoma de Querétaro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: March 30, 2021
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Pulpitis
• Symptomatic Irreversible Pulpitis

Intervention

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.

Locations

Country	Name	City	State
Mexico	Centro de Salud -La Negreta- Jurisdicción Sanitaria 1 del Estado de Querétaro	Querétaro

Sponsors (1)

Lead Sponsor	Collaborator
Rubén Domínguez Pérez

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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