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Clinical Trials in Egypt / NCT06288477
Recruiting Not applicable

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 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2024-03-20
Last updated
2024-12-20

Condition(s) studied

VitalPulpotomyTechniques

Investigational drug(s) / intervention(s)

A cotton pellet moistened with full-strength FCNeo-Putty

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).

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).

Study 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

Eligibility

Sex
ALL
Min age
4 Years
Max age
9 Years
Healthy volunteers
Accepted
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).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
MSA University El-Sheikh Zayed City Giza Governorate Recruiting

More October University for Modern Sciences and Arts trials in Egypt

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06288477 on ClinicalTrials.gov ↗ ← All trials in Egypt