NCT07437794

Clinical and Radiographic Assessment of Neo Putty MTA Versus Formocresol Used in Vital Pulpotomy of Mandibular Primary Molars

Clinical and Radiographic Assessment of Neo Putty MTA Versus Formocresol Used in Vital Pulpotomy of Mandibular Primary Molars: A Randomized Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: October University for Modern Sciences and Arts · Academic / Other
• Sex: All
• Age: 4 Years – 9 Years
• Healthy volunteers: Not accepted

Summary

This randomized clinical trial aims to evaluate the clinical and radiographic success of NeoPutty MTA compared to formocresol in vital pulpotomy of mandibular primary molars in children aged 4 to 9 years. Participants will be randomly allocated into two groups (1:1) to receive pulpotomy using either NeoPutty MTA or formocresol, followed by restoration with stainless steel crowns. Clinical and radiographic outcomes will be assessed during follow-up visits.

Detailed description

Pulpotomy is a commonly performed vital pulp therapy in pediatric dentistry. Formocresol has been widely used due to its high clinical success; however, concerns exist regarding its potential toxicity. NeoPutty MTA is a premixed bioceramic material introduced as an alternative pulpotomy agent with improved handling properties and bioactivity. This randomized parallel-group clinical trial will compare NeoPutty MTA versus formocresol in vital pulpotomy of mandibular primary molars. Children aged 4-9 years presenting with asymptomatic carious mandibular primary molars will be recruited from the Pediatric Dentistry Department, Faculty of Dentistry, MSA University. Eligible teeth will undergo standardized pulpotomy procedures, restoration with glass ionomer cement, and stainless steel crowns. Clinical and radiographic follow-up will be performed at scheduled intervals to evaluate success and failure outcomes.

Conditions

• Deep Caries in Primary Molars

Interventions

Type	Name	Description
DRUG	NeoPutty MTA	NeoPutty MTA (NuSmile) will be placed directly over the radicular pulp stumps after hemostasis, then the tooth will be sealed with resin-modified glass ionomer cement and restored with stainless steel crown.
DRUG	Formocresol	A sterile cotton pellet lightly moistened with a 1:5 dilution of Buckley's formocresol will be placed against the pulp stumps for 3-5 minutes, then removed. Reinforced zinc oxide eugenol will be placed, followed by glass ionomer cement and stainless steel crown restoration.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-04-01
• Completion: 2026-05-01
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: Egypt