Status:
COMPLETED
Intentional Pulpotomy to Preserve Hopeless Molars
Lead Sponsor:
University of Florida
Collaborating Sponsors:
NuSmile, Ltd and Avalon Biomed
Conditions:
Pulpitis
Dental Pulp Diseases
Eligibility:
All Genders
5-10 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
June 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2023
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04385693
Start Date
June 12 2020
End Date
April 12 2023
Last Update
June 6 2023
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610