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

NCT05199181 | Completed

• 1 other identifier: JS1/ENS/215/220
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Symptomatic Irreversible Pulpitis

Keywords

symptomatic irreversible pulpitis; full pulpotomy; mature teeth

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Satisfaction with the effect of the treatment

  24 Hours

Study Arms (1)

Full pulpotomy

EXPERIMENTAL

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

Procedure: Full pulpotomy

Interventions

Full pulpotomy 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.

Full pulpotomy

Eligibility Criteria

• Age: 17 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rubén Domínguez Pérez: lead

Study Sites (1)

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

Querétaro, 76138, Mexico

Location

Study Officials

• Roberto Sanchez-Lara y Tajonar, DDS, Endod

  Universidad Autónoma de Querétaro

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of department Multidisciplinary Dentistry Research

Model Details: Longitudinal prospective single-arm cohort clinical study

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 20, 2022
• Study Start: November 19, 2019
• Primary Completion: March 20, 2020
• Study Completion: March 30, 2021
• Last Updated: January 20, 2022

Record last verified: 2022-01

Locations

ME (1)