Intentional Pulpotomy to Preserve Hopeless Molars

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University of Florida

Status

Completed

Conditions

Dental Pulp Diseases
Pulpitis
Tooth Diseases

Treatments

Procedure: Extraction and placement of space maintainer
Procedure: Pulpotomy

Study type

Interventional

Funder types

Other

Identifiers

NCT04385693
OCR34882 (Other Identifier)
IRB202000068

Details and patient eligibility

About

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

Enrollment

17 patients

Sex

All

Ages

5 to 10 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

17 participants in 2 patient groups

Pulpotomy
Experimental group
Description:
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.
Treatment:
Procedure: Pulpotomy
Control Group
Active Comparator group
Description:
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.
Treatment:
Procedure: Extraction and placement of space maintainer

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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