PulpitisNCT04385693
Intentional Pulpotomy to Preserve Hopeless Molars
A study testing Pulpotomy and Extraction and placement of space maintainer in people with Pulpitis and Dental Pulp Diseases, run by University of Florida at 1 site in United States.
Trial summary
When proximal carious lesions of primary molars are located in close proximity to the cementum enamel junction (CEJ), marginal seal is challenging and extraction is recommended. Pulpotomy is indicated for vital primary teeth to preserve them in function. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis, Dental Pulp Diseases, Tooth Diseases
- What is being tested?
- Pulpotomy and Extraction and placement of space maintainer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2020to 12 Apr 2023
- 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 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Selected patients will have one or more primary molar teeth diagnosed clinically with large proximal carious lesions with the gingival extension of the cavity at or below the cemento-enamel junction. The tooth should be asymptomatic and must have no signs of swelling, fistula, abnormal mobility and sensitivity to percussion (ruling out food impaction), and adequate space for placement of a stainless steel crown restoration. The pre-operative periapical radiograph, taken as part of the new patient/recall routine visit, should reveal a lesion in close approximation to the pulp, but having at least 1-2 mm of sound dentin separating the deepest portion of the lesion and the pulp. In addition, no evidence of furcation and periapical pathology, internal or external root resorption and presence of half to two-thirds of root length remaining.
Who cannot join
- Uncooperative patients
- Teeth with positive history of pain, abnormal mobility, signs of pulp necrosis such as presence of swelling or fistula, and significant space loss due to caries not allowing placement of a stainless steel crown restoration
- Radiographically, signs of furcation and periapical pathology, internal and external resorption, less than half to 2/3 of root length remaining
- Selected patients will be treated by pediatric dental residents in the regular dental clinic setting with or without nitrous oxide inhalation, as part of the standard of care
- Prior to the beginning of the study, all operators will be calibrated by the principal investigator on identifying the teeth in question, as well as on the restorative technique
- Selected patients may have one or more qualified teeth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intentional Pulpotomy to Preserve Vital Primary Molars With Challenging Restorability: a Feasibility Study
When proximal carious lesions of primary molars are located in close proximity to the cementum enamel junction (CEJ), marginal seal is challenging and extraction is recommended. Pulpotomy is indicated for vital primary teeth to preserve them in function. The goal of this study is to monitor the long-term effect of intentional bioactive cement pulpotomies and crown coverage performed on vital and asymptomatic carious primary molars with gingival margins close to or at the CEJ
- Conditions
- Pulpitis, Dental Pulp Diseases, Tooth Diseases
- Being tested
- Pulpotomy, Extraction and placement of space maintainer
- Medical subject headings
- Pulpitis, Dental Pulp Diseases, Tooth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulpotomyProcedure or surgery
Pulpotomy using bioactive bioceramic cement of 1.5 mm layer of a newly FDA approved calcium-based silicate cement (Nusmile NeoPutty) will be placed on the pulp chamber floor and canals' orifices for pulp and root therapy. Pulpotomy is a procedure in which the coronal pulp is amputated, and the remaining radicular pulp tissue is treated with a medicament to preserve the pulp's health.This technique involves administration of local analgesia, Isolation of the tooth with rubber dam, complete caries removal and then access to the pulp chamber using drills.
Extraction and placement of space maintainerProcedure or surgery
If during the pulpotomy procedure, hemostasis is not obtainable, or signs of advanced pulp degeneration such as dark and limited or no bleeding from canals, the pulp will be diagnosed as chronically inflamed or necrotic, and tooth will be extracted. As part of the standard of care after extractions of primary molars, space maintenance will be assessed, and a space maintainer fabricated if indicated. Extracted teeth will serve as controls, and information regarding the need or not of space maintenance.
| Study group | Role | What they receive |
|---|---|---|
| Pulpotomy | Experimental | Group A: The patient will benefit from an experimental treatment: a Pulpotomy. The pulpotomy aims at removing the coronal part of the pulp (the pulp present in the pulp chamber) and filling the pulp chamber with a bioactive material. Receives: Procedure: Pulpotomy |
| Control Group | Active comparator | Group B: Extracted teeth will serve as controls, and information regarding the need or not of space maintenance, and the impact on the occlusion and eruption of the succedaneous permanent tooth will be noted. Receives: Procedure: Extraction and placement of space maintainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic examination for each recall visit
Evaluation of asymptomatic tooth in the mouth for presence of infection (bite -wing/periapical radiograph(s)
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start12 Jun 2020
- Primary completion12 Apr 2023
- Study completion12 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PulpitisStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- NuSmile, Ltd and Avalon Biomed
- Responsible party
- Sponsor
- Investigators
- Marcio Guelmann, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385693
- Sponsor's protocol ID
- IRB202000068
- Other IDs
- OCR34882
- Status last verified
- Jun 2023
- First submitted
- 1 May 2020
- Last updated
- 6 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intentional Pulpotomy to Preserve Vital Primary Molars With Challenging Restorability: a Feasibility Study
- ClinicalTrials.gov ID
- NCT04385693
- Acronym / sponsor ID
- IRB202000068
- Conditions
- Pulpitis, Dental Pulp Diseases, Tooth Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- NuSmile, Ltd and Avalon Biomed
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 12 Apr 2023 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 13 May 2020 (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.
When proximal carious lesions of primary molars are located in close proximity to the cementum enamel junction (CEJ), marginal seal is challenging and extraction is recommended. Pulpotomy is indicated for vital primary teeth to preserve them in function. The goal of this study is to monitor the long-term effect of intentional bioactive cement pulpotomies and crown coverage performed on vital and asymptomatic carious primary molars with gingival margins close to or at the CEJ
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulpotomy | Experimental | Procedure: PulpotomyGroup A: The patient will benefit from an experimental treatment: a Pulpotomy. The pulpotomy aims at removing the coronal part of the pulp (the pulp present in the pulp chamber) and filling the pulp chamber with a bioactive material. |
| Control Group | Active comparator | Procedure: Extraction and placement of space maintainerGroup B: Extracted teeth will serve as controls, and information regarding the need or not of space maintenance, and the impact on the occlusion and eruption of the succedaneous permanent tooth will be noted. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Selected patients will have one or more primary molar teeth diagnosed clinically with large proximal carious lesions with the gingival extension of the cavity at or below the cemento-enamel junction. The tooth should be asymptomatic and must have no signs of swelling, fistula, abnormal mobility and sensitivity to percussion (ruling out food impaction), and adequate space for placement of a stainless steel crown restoration. The pre-operative periapical radiograph, taken as part of the new patient/recall routine visit, should reveal a lesion in close approximation to the pulp, but having at least 1-2 mm of sound dentin separating the deepest portion of the lesion and the pulp. In addition, no evidence of furcation and periapical pathology, internal or external root resorption and presence of half to two-thirds of root length remaining.
Key exclusion criteria (6 listed)
- Uncooperative patients
- Teeth with positive history of pain, abnormal mobility, signs of pulp necrosis such as presence of swelling or fistula, and significant space loss due to caries not allowing placement of a stainless steel crown restoration
- Radiographically, signs of furcation and periapical pathology, internal and external resorption, less than half to 2/3 of root length remaining
- Selected patients will be treated by pediatric dental residents in the regular dental clinic setting with or without nitrous oxide inhalation, as part of the standard of care
- Prior to the beginning of the study, all operators will be calibrated by the principal investigator on identifying the teeth in question, as well as on the restorative technique
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 |
|---|---|---|
| PulpotomyPulpotomy using bioactive bioceramic cement of 1.5 mm layer of a newly FDA approved calcium-based silicate cement (Nusmile NeoPutty) will be placed on the pulp chamber floor and canals' orifices for pulp and root therapy. Pulpotomy is a procedure in which the coronal pulp is amputated, and the remaining radicular pulp tissue is treated with a medicament to preserve the pulp's health.This technique involves administration of local analgesia, Isolation of the tooth with rubber dam, complete caries removal and then access to the pulp chamber using drills. | Procedure or surgery | Pulpotomy |
| Extraction and placement of space maintainerIf during the pulpotomy procedure, hemostasis is not obtainable, or signs of advanced pulp degeneration such as dark and limited or no bleeding from canals, the pulp will be diagnosed as chronically inflamed or necrotic, and tooth will be extracted. As part of the standard of care after extractions of primary molars, space maintenance will be assessed, and a space maintainer fabricated if indicated. Extracted teeth will serve as controls, and information regarding the need or not of space maintenance. | Procedure or surgery | Control Group |
Primary outcome
Radiographic examination for each recall visit
Time frame: up to 1 year
Evaluation of asymptomatic tooth in the mouth for presence of infection (bite -wing/periapical radiograph(s)
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 6 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Marcio Guelmann principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulpotomy and Extraction and placement of space maintainer in people with Pulpitis and Dental Pulp Diseases, run by University of Florida at 1 site in United States.
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 1 inclusion and 6 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 6 Jun 2023. 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 United States. 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?
Radiographic examination for each recall visit (time frame: up to 1 year). 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 6 Jun 2023.