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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-9
SponsorOctober University for Modern Sciences and Arts

About this 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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

4 -9 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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • 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).

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: full-strength FCActive comparator 1 intervention
Group B: Neo-Putty®Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Clinical success

• Success clinically and radiographically will assess by the number of participants with symptoms-free and no peri-radicular pathology

Time frame
(at 3,6,9and 12 months)

Secondary outcomes

Other outcomes

Sponsors and contacts

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