Effectiveness of Premixed Bioactive Bioceramic MTA (Neo-Putty®) in Pulpotomies Primary Teeth

Sponsor

Hadassah Medical Organization (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04962607

Collaborator

(none)

100

Enrollment

Location

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this prospective randomized clinical trial is to assess clinically and radiographically, the effect of NeoPutty as a pulp medicament following coronal pulp amputation in human primary molars with carious pulp exposure in comparison to Formocresol (FC).

Condition or Disease	Intervention/Treatment	Phase
Pulpotomies on Primary Molars	Other: Neo-Putty® as dressing agents in pulpotomized primary molars

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Effectiveness of Premixed Bioactive Bioceramic MTA (Neo-Putty®) Versus Formocresol as Dressing Agents in Pulpotomized Primary Molars

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Study Group Asymptomatic primary molars with deep carious lesions scheduled for regular treatment. Exposure of a vital pulp due to caries. No clinical or radiographic evidence of pulp degeneration, such as spontaneous pain, excessive bleeding from the root canal, internal root resorption, inter-radicular and/or periapical bone destruction, swelling, or sinus tract. The possibility of proper restoration of the teeth.	Other: Neo-Putty® as dressing agents in pulpotomized primary molars Following removal of the coronal pulp with a round bur and hemostasis, the pulp stumps in the study group will be covered with Neo-Putty ® according to the manufacturer's instructions. Neo-Putty will be placed in the prepared cavity, and then covered with Vitrebond® and with a reinforced Zinc Oxide-Eugenol (IRM, Bayer-Leverkussen, Germany). In the control group, a cotton pellet moistened with full-strength FC will be placed for 5 minutes on the amputated pulp, after reaching hemostasis. The pulp stumps will be then covered by IRM
control group Asymptomatic primary molars with deep carious lesions scheduled for regular treatment. Exposure of a vital pulp due to caries. No clinical or radiographic evidence of pulp degeneration, such as spontaneous pain, excessive bleeding from the root canal, internal root resorption, inter-radicular and/or periapical bone destruction, swelling, or sinus tract. The possibility of proper restoration of the teeth.	Other: Neo-Putty® as dressing agents in pulpotomized primary molars Following removal of the coronal pulp with a round bur and hemostasis, the pulp stumps in the study group will be covered with Neo-Putty ® according to the manufacturer's instructions. Neo-Putty will be placed in the prepared cavity, and then covered with Vitrebond® and with a reinforced Zinc Oxide-Eugenol (IRM, Bayer-Leverkussen, Germany). In the control group, a cotton pellet moistened with full-strength FC will be placed for 5 minutes on the amputated pulp, after reaching hemostasis. The pulp stumps will be then covered by IRM

Arm

Intervention/Treatment

Study Group

Asymptomatic primary molars with deep carious lesions scheduled for regular treatment. Exposure of a vital pulp due to caries. No clinical or radiographic evidence of pulp degeneration, such as spontaneous pain, excessive bleeding from the root canal, internal root resorption, inter-radicular and/or periapical bone destruction, swelling, or sinus tract. The possibility of proper restoration of the teeth.

Other: Neo-Putty® as dressing agents in pulpotomized primary molars

Following removal of the coronal pulp with a round bur and hemostasis, the pulp stumps in the study group will be covered with Neo-Putty ® according to the manufacturer's instructions. Neo-Putty will be placed in the prepared cavity, and then covered with Vitrebond® and with a reinforced Zinc Oxide-Eugenol (IRM, Bayer-Leverkussen, Germany). In the control group, a cotton pellet moistened with full-strength FC will be placed for 5 minutes on the amputated pulp, after reaching hemostasis. The pulp stumps will be then covered by IRM

control group

Other: Neo-Putty® as dressing agents in pulpotomized primary molars

Outcome Measures

Primary Outcome Measures

Success rate of the primary molar pulpotomy [One year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

primary teeth which requires pulpotomy.

Exclusion Criteria:

not healthy patients,
teeth which requires pulpectomy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hadassah Medical Organization	Jerusalem		Israel	91120

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hadassah Medical Organization

ClinicalTrials.gov Identifier:

NCT04962607

Other Study ID Numbers:

0994-20-HMO

First Posted:

Jul 15, 2021

Last Update Posted:

Mar 16, 2022

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Study Results

No Results Posted as of Mar 16, 2022