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

NCT04962607 | Active Not Recruiting

• 1 other identifier: 0994-20-HMO
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Pulpotomies on Primary Molars

Outcome Measures

Primary Outcomes (1)

• Success rate of the primary molar pulpotomy

  One year

Study Arms (2)

Study Group

1. Asymptomatic primary molars with deep carious lesions scheduled for regular treatment. 2. Exposure of a vital pulp due to caries. 3. 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. 4. The possibility of proper restoration of the teeth.

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

control group

1. Asymptomatic primary molars with deep carious lesions scheduled for regular treatment. 2. Exposure of a vital pulp due to caries. 3. 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. 4. The possibility of proper restoration of the teeth.

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

Interventions

Neo-Putty® as dressing agents in pulpotomized primary molars OTHER

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

Study Group; control group

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Healthy children attending the Pediatric Dentistry Clinic of the Hebrew University-Hadassah School of Dental Medicine in Jerusalem

You may qualify if:

• primary teeth which requires pulpotomy.

You may not qualify if:

• not healthy patients,
• teeth which requires pulpectomy.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 15, 2021
• Study Start: September 1, 2021
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)