Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:57 AM
Study NCT ID:
NCT07437794
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Radiographic Assessment of Neo Putty MTA Versus Formocresol Used in Vital Pulpotomy of Mandibular Primary Molars
Sponsor:
October University for Modern Sciences and Arts
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: