What this Trial Is About

Researchers are evaluating the effectiveness of a new premixed bioactive bioceramic material called Neo-Putty as a pulp treatment in children's primary molars with carious pulp exposure. This randomized clinical trial compares Neo-Putty with the traditional formocresol (FC) pulpotomy technique. The study aims to determine whether Neo-Putty offers better clinical and radiographic success in preserving the vital pulp tissue while avoiding the toxic effects and reported side effects associated with formocresol. The trial includes two treatment groups. In the control group, a cotton pellet moistened with full-strength formocresol is applied for 5 minutes to the amputated pulp after bleeding stops, followed by coverage with an intermediate restorative material (IRM). In the intervention group, after removing the coronal pulp and achieving hemostasis, the pulp stumps are covered with Neo-Putty according to the manufacturer's instructions, then sealed with reinforced zinc oxide-eugenol (IRM). The study uses a randomized, parallel design with blinding of participants, guardians, and the statistician. Participants will be monitored clinically and radiographically at 3, 6, 9, and 12 months to assess treatment success. Success is defined by the absence of symptoms such as spontaneous pain, excessive bleeding, internal root resorption, bone destruction, swelling, or sinus tract. The study will provide important data on the safety and effectiveness of Neo-Putty compared to formocresol, potentially influencing pediatric dental care worldwide.

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