Full Pulpotomy in Mature Teeth With Symptomatic Irreversible Pulpitis as a Routine Treatment in the Primary Care Clinics
Primary Purpose
Symptomatic Irreversible Pulpitis
Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Full pulpotomy
Sponsored by
About this trial
This is an interventional treatment trial for Symptomatic Irreversible Pulpitis focused on measuring symptomatic irreversible pulpitis, full pulpotomy, mature teeth
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.
- Teeth exclusion criteria:
- Pathological mobility
- Sinus tract
- Teeth that cannot be restored with amalgam
- Radiographic internal or external resorption
- Presence of apical rarefaction
Sites / Locations
- Centro de Salud -La Negreta- Jurisdicción Sanitaria 1 del Estado de Querétaro
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Full pulpotomy
Arm Description
All patients were treated in one visit (with Full Pulpotomy); the previously trained General Practice Dentist performed all the clinical procedures
Outcomes
Primary Outcome Measures
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
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
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
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
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
Secondary Outcome Measures
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".
Full Information
NCT ID
NCT05199181
First Posted
January 3, 2022
Last Updated
January 14, 2022
Sponsor
Rubén Domínguez Pérez
1. Study Identification
Unique Protocol Identification Number
NCT05199181
Brief Title
Full Pulpotomy in Mature Teeth With Symptomatic Irreversible Pulpitis as a Routine Treatment in the Primary Care Clinics
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
November 19, 2019 (Actual)
Primary Completion Date
March 20, 2020 (Actual)
Study Completion Date
March 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rubén Domínguez Pérez
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Irreversible Pulpitis
Keywords
symptomatic irreversible pulpitis, full pulpotomy, mature teeth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Longitudinal prospective single-arm cohort clinical study
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Full pulpotomy
Arm Type
Experimental
Arm Description
All patients were treated in one visit (with Full Pulpotomy); the previously trained General Practice Dentist performed all the clinical procedures
Intervention Type
Procedure
Intervention Name(s)
Full pulpotomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment success rate
Description
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
Time Frame
1 Month follow-up
Title
Treatment success rate
Description
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
Time Frame
3 Months follow-up
Title
Treatment success rate
Description
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
Time Frame
6 Months follow-up
Title
Treatment success rate
Description
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
Time Frame
9 Months follow-up
Title
Treatment success rate
Description
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
Time Frame
12 Months follow-up
Secondary Outcome Measure Information:
Title
Satisfaction with the effect of the treatment
Description
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".
Time Frame
24 Hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Teeth exclusion criteria:
Pathological mobility
Sinus tract
Teeth that cannot be restored with amalgam
Radiographic internal or external resorption
Presence of apical rarefaction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Sanchez-Lara y Tajonar, DDS, Endod
Organizational Affiliation
Universidad Autónoma de Querétaro
Official's Role
Study Director
Facility Information:
Facility Name
Centro de Salud -La Negreta- Jurisdicción Sanitaria 1 del Estado de Querétaro
City
Querétaro
ZIP/Postal Code
76138
Country
Mexico
12. IPD Sharing Statement
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Full Pulpotomy in Mature Teeth With Symptomatic Irreversible Pulpitis as a Routine Treatment in the Primary Care Clinics
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