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Intentional Pulpotomy to Preserve Hopeless Molars

Primary Purpose

Pulpitis, Dental Pulp Diseases, Tooth Diseases

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Pulpotomy

Extraction and placement of space maintainer

About this trial

This is an interventional treatment trial for Pulpitis

Eligibility Criteria

5 Years - 10 Years (Child)All SexesAccepts 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

Sites / Locations

University of Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pulpotomy

Control Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Radiographic examination for each recall visit

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04385693

First Posted

May 1, 2020

Last Updated

June 5, 2023

Sponsor

University of Florida

Collaborators

NuSmile, Ltd and Avalon Biomed

1. Study Identification

Unique Protocol Identification Number

NCT04385693

Brief Title

Intentional Pulpotomy to Preserve Hopeless Molars

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

June 12, 2020 (Actual)

Primary Completion Date

April 12, 2023 (Actual)

Study Completion Date

April 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Florida

Collaborators

NuSmile, Ltd and Avalon Biomed

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulpitis, Dental Pulp Diseases, Tooth Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pulpotomy

Arm Type

Experimental

Arm Description

Arm Title

Control Group

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Pulpotomy

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Extraction and placement of space maintainer

Intervention Description

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.

Primary Outcome Measure Information:

Title

Radiographic examination for each recall visit

Description

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

Time Frame

up to 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marcio Guelmann

Organizational Affiliation

University of Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Intentional Pulpotomy to Preserve Hopeless Molars

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