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

Active, not recruiting

• Conditions: Pulpotomies on Primary Molars
• Interventions: Other: Neo-Putty® as dressing agents in pulpotomized primary molars

• Registration Number: NCT04962607
• Lead Sponsor: Hadassah Medical Organization

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-28
• Study First Submitted QC: 2021-07-14
• Study First Posted: 2021-07-15
• Study Start: 2021-09-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-18
• Last Update Posted: 2023-01-20
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• primary teeth which requires pulpotomy.

Exclusion Criteria

• not healthy patients,
• teeth which requires pulpectomy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Group	Neo-Putty® as dressing agents in pulpotomized primary molars	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.
control group	Neo-Putty® as dressing agents in pulpotomized primary molars	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.

Primary Outcome Measures

Name	Time	Method
Success rate of the primary molar pulpotomy	One year

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel