Symptomatic Irreversible PulpitisNCT05199181
Full Pulpotomy in Mature Teeth With Symptomatic Irreversible Pulpitis as a Routine Treatment in the Primary Care Clinics
A study testing Full pulpotomy in people with Symptomatic Irreversible Pulpitis, run by Rubén Domínguez Pérez at 1 site in Mexico.
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… Read more about this study
- Who is it for?
- Ages 17 to 100 years
- Conditions the study is for
- Symptomatic Irreversible Pulpitis
- What is being tested?
- Full pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteMexico
- Study dates
- 19 Nov 2019to 30 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Centro de Salud -La Negreta- Jurisdicción Sanitaria 1 del Estado de Querétaro
Querétaro, 76138
About this study
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
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.
Read the 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.
- Conditions
- Symptomatic Irreversible Pulpitis
- Being tested
- Full pulpotomy
- Keywords
- symptomatic irreversible pulpitis, full pulpotomy, mature teeth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full pulpotomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Full pulpotomy | Experimental | All patients were treated in one visit (with Full Pulpotomy); the previously trained General Practice Dentist performed all the clinical procedures Receives: Procedure: Full pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 Months follow-up
Secondary outcomes (1)
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".
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start19 Nov 2019
- Primary completion20 Mar 2020
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Irreversible PulpitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Longitudinal prospective single-arm cohort clinical study
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rubén Domínguez Pérez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rubén Domínguez Pérez, Universidad Autónoma de Querétaro
- Investigators
- Roberto Sanchez-Lara y Tajonar, DDS, Endod, Study director, Universidad Autónoma de Querétaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199181
- Sponsor's protocol ID
- JS1/ENS/215/220
- Status last verified
- Jan 2022
- First submitted
- 3 Jan 2022
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05199181
- Acronym / sponsor ID
- JS1/ENS/215/220
- Conditions
- Symptomatic Irreversible Pulpitis
- Keywords
- symptomatic irreversible pulpitis, full pulpotomy, mature teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Rubén Domínguez PérezUniversity, hospital or other
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Longitudinal prospective single-arm cohort clinical study
| Arm | Type | Receives |
|---|---|---|
| Full pulpotomy | Experimental | Procedure: Full pulpotomyAll patients were treated in one visit (with Full Pulpotomy); the previously trained General Practice Dentist performed all the clinical procedures |
Who may qualify
- Ages
- 17 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- Medically comprised or pregnant patients.
- Teeth exclusion criteria:
- Pathological mobility
- Sinus tract
- Teeth that cannot be restored with amalgam
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full pulpotomyAfter 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. | Procedure or surgery | Full pulpotomy |
Primary outcome
Treatment success rate
Time frame: 1 Month follow-up
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
Time frame: 3 Months follow-up
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
Time frame: 6 Months follow-up
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
Time frame: 9 Months follow-up
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
Time frame: 12 Months follow-up
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
1 secondary outcome
Satisfaction with the effect of the treatment
Time frame: 24 Hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Sanchez-Lara y Tajonar, DDS, Endod study director
Universidad Autónoma de Querétaro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full pulpotomy in people with Symptomatic Irreversible Pulpitis, run by Rubén Domínguez Pérez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment success rate (time frame: 1 Month follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2022.