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Intentional Pulpotomy to Preserve Hopeless Molars

Not Applicable
Completed
Conditions
Pulpitis
Dental Pulp Diseases
Tooth Diseases
Registration Number
NCT04385693
Lead Sponsor
University of Florida
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 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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
17
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Radiographic examination for each recall visitup to 1 year

Evaluation of asymptomatic tooth in the mouth for presence of infection (bite -wing/periapical radiograph(s)

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of Florida

🇺🇸

Gainesville, Florida, United States

University of Florida
🇺🇸Gainesville, Florida, United States

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