Clinical and Radiographic Evaluation of Vital Pulpotomy Techniques in Primary Molars Using of Premixed Bioactive Bioceramic MTA (Neo-putty) as a Novel Pulpotomy Medication Versus Formocresol

Clinical and Radiographic Evaluation of Vital Pulpotomy Techniques in Primary Molars Using of Premixed Bioactive Bioceramic MTA (Neo-putty) as a Novel Pulpotomy Medication Versus Formocresol: A Randomized Clinical Trial.

Despite the benefit of formocresol, there are toxic effects allergic reactions and local soft and hard tissue necrosis have been reported when such formaldehyde compounds were used clinically, however, the adverse effect of the clinically used of this compound are not widely reported. It has been stated that it has a side effect on the permanent successor although it results as a successful technique for the treatment of the primary teeth

Study Overview

• Status: Recruiting
• Conditions: Pulpotomy; Techniques; Vital
• Intervention / Treatment: Drug: A cotton pellet moistened with full-strength FC; Drug: Neo-Putty

Detailed Description

The rationale for conducting the research:

Nowadays, the introduction of new Bio-inductive materials resulted in the shift of the concept of preservation of radicular pulp tissue to regeneration. Restoration of the anatomical continuity of damaged tissue and disturbed functional status of the radicular pulp tissue require an appropriate method of wound healing which includes well-organized, biochemical and cellular events, leading to the growth and regeneration of injured radicular tissue in a special manner.

A higher standard in bioactive bioceramic putty as manufacture claimed the Neo-Putty® NuSmile is a bioactive bioceramic premixed root and pulp treatment with superior handling properties, promoting hydroxyapatite formation to support the healing process. Neo-Putty® is a premixed bioactive bioceramic root & pulp treatment consisting of an extremely fine, inorganic powder of tricalcium/dicalcium silicate in a water free organic liquid. The product is packaged ready to use. No mixing is required. Neo-Putty® is designed to set in vivo in the presence of moisture from the surrounding tissues. Considering the limitations of these data, we are conduction this clinical trial. The outcomes of this study will have a substantial impact on clinical practice for pediatric patients, as well as patient care, around the world.

Aim of the study:

This randomized clinical trial study will assess clinically and radiographically, the effect of Neo-Putty® as a pulp medicament following coronal pulp amputation in children's primary molars with carious pulp exposure in comparison to Formocresol (FC).

Research question:

Is the pulpotomy procedure in primary molars using premixed Bioactive bioceramic MTA (Neo-putty) more clinically successful than Formocresol?

PICOS:

P: Carious primary molars with no spontaneous or provoked pain (vital primary molars) I: Neo-Putty® as dressing agents in pulpotomized primary molars C: Formocresol Pulpotomy (FC) O: Clinical Success S: In-Vivo Study II. Methods

Study Design:

Study Type: Interventional (Clinical Trial) Estimated Enrolment: 88 participants Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Treatment Official Title: Clinical and Radiographic Evaluation of Vital Pulpotomy in Primary Molars using of premixed Bioactive bioceramic MTA (Neo-putty) as a Novel Pulpotomy Medication versus Formocresol: A Randomized Clinical Trial. Estimated Study Start Date: December 2023 Estimated Primary Completion Date: January 2024

Trial design:

The study is a randomized clinical trial (RCT) where 2 arm parallel groups with a 1:1 allocation ratio were compared. The child participants and the legal guardian of each participating child and the statistician were blinded.

Interventions 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.

In the Intervention group:

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 a reinforced Zinc Oxide-Eugenol (IRM, Bayer-Leverkussen, Germany).

Outcome Measures:

1. Primary outcome: Clinical success [Time Frame: 12 months].

• Success clinically and radiographically will assess by the number of participants with symptoms-free and no peri-radicular pathology (at 3,6,9and 12 months)
• 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.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marwa A Salmoon, Ph.D; Phone Number: 01016555055; Email: maasalmoon@msa.edu.eg
• Study Contact Backup: Name: Marwa A Salamon, Ph.D; Phone Number: +20 101 655 5055; Email: maasalmon@msa.edu.eg

Study Locations

• Egypt
  • Giza
    • El-Sheikh Zayed City, Giza, Egypt, 16672
      • Recruiting
      • MSA University
      • Contact: Marwa A Salmoon, Ph. D; Phone Number: 01016555055
      • Contact: Marwa A Salmoon, Ph.D; Email: maasalmoon@msa.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Criteria The eligibility criteria were set according to the guidelines of AAPD, 2020. (4)

Inclusion Criteria:

1. 4 -9 years old
2. Primary molars with no spontaneous or provoked pain
3. Primary molars with at least two-thirds of the root length were still present.
4. Primary molars with no sign of internal or other kinds of root or bone resorption.

Exclusion Criteria:

1. Patients with systemic diseases (congenital or rheumatic heart disease, hepatitis, nephritis, tumor, cyclic neutropenia, leukemia, and children on long-term corticosteroid therapy).
2. Un-cooperative patients.
3. Un-restorable primary molars (Grossly broken-down primary molars that have decay extending way under the gingiva and tooth with root caries).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: full-strength FC; Formocresol pulpotomy is one of the most common procedure in cases of mechanical and carious exposure in primary teeth.	Drug: A cotton pellet moistened with full-strength FC; 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 (Intermediate Restorative Material).
Experimental: Neo-Putty®; Neo-Putty® as dressing agents in pulpotomized primary molars. NeoPUTTY® is composed of extremely fine inorganic tricalcium/dicalcium silicate powders in a water-free organic liquid and contains tantalum oxide as the radiopacifying agent.	Drug: Neo-Putty; 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 a reinforced Zinc Oxide-Eugenol (IRM, Bayer-Leverkussen, Germany).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical success	• Success clinically and radiographically will assess by the number of participants with symptoms-free and no peri-radicular pathology	(at 3,6,9and 12 months)

Collaborators and Investigators

• Sponsor: October University for Modern Sciences and Arts

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2024
• Primary Completion (Actual): May 1, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: February 23, 2024
• First Submitted That Met QC Criteria: February 23, 2024
• First Posted (Actual): March 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2023-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No