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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Symptomatic Irreversible Pulpitis

Intervention / Treatment
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* Procedure: Full pulpotomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Longitudinal prospective single-arm cohort clinical study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full pulpotomy<br>All patients were treated in one visit (with Full Pulpotomy); the previously trained General Practice Dentist performed all the clinical procedures | Procedure: Full pulpotomy<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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symptomatic irreversible pulpitis, full pulpotomy, mature teeth