Intentional Pulpotomy to Preserve Hopeless Molars

Pulpitis Clinical Trial

Official title:

Intentional Pulpotomy to Preserve Vital Primary Molars With Challenging Restorability: a Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04385693
• Other study ID #: IRB202000068
• Secondary ID: OCR34882
• Status: Completed
• Phase: N/A
• Start date: June 12, 2020
• Est. completion date: April 12, 2023

Study information

• Verified date: June 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: April 12, 2023
• Est. primary completion date: April 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Dental Pulp Diseases
• Pulpitis
• Tooth Diseases

Intervention

Procedure:
• Pulpotomy
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 maintainer
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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	NuSmile, Ltd and Avalon Biomed

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic examination for each recall visit	Evaluation of asymptomatic tooth in the mouth for presence of infection (bite -wing/periapical radiograph(s)	up to 1 year