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

NCT06288477 | Recruiting

• 1 other identifier: 2023-2
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vital; Pulpotomy; Techniques

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

full-strength FC

ACTIVE COMPARATOR

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

Neo-Putty®

EXPERIMENTAL

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

Interventions

A cotton pellet moistened with full-strength FC DRUG

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).

full-strength FC

Neo-Putty DRUG

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).

Neo-Putty®

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• October University for Modern Sciences and Arts: lead

Study Sites (1)

MSA University

El-Sheikh Zayed City, Giza Governorate, 16672, Egypt

RECRUITING

Central Study Contacts

Marwa A Salamon, Ph.D

CONTACT

+20 101 655 5055; maasalmon@msa.edu.eg

Marwa A Salmoon, Ph.D

CONTACT

01016555055; maasalmoon@msa.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 1, 2024
• Study Start: March 20, 2024
• Primary Completion: May 1, 2024
• Study Completion: February 1, 2025
• Last Updated: December 20, 2024

Record last verified: 2024-12

Locations

EG (1)