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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Deep Caries in Primary Molars
• Intervention / Treatment: Drug: NeoPutty MTA; Drug: Formocresol

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 Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Shawky, bachelor of dentistry; Phone Number: +201124465202; Email: ahmed.shawky3@msa.edu.eg

Study Locations

• Egypt
  • Giza Governorate
    • Giza, Giza Governorate, Egypt, 12116
      • October University for Modern Sciences and Arts
      • Contact: Ahmed Shawky; Phone Number: +201124465202; Email: ahmed.shawky3@msa.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Children with asymptomatic decayed primary mandibular molar(s).

• Patient and parent showing cooperation and compliance.
• Children 4-9 years old.
• Vital carious primary(s) with complete root formation.
• Asymptomatic teeth or without clinical symptoms of spontaneous pain.
• No clinical evidence of pulp degeneration like the history of spontaneous or nocturnal pain, tenderness to percussion, pathologic tooth mobility, swelling, or fistulous tract.
• Both genders will be included.
• No radiographic evidence of pulp degeneration such as internal root resorption, external root resorption, or furcal radiolucency.
• Presence of two thirds of the root.
• Teeth that can be restored.
• Children with prior parental consent.

Exclusion Criteria:

• History of any systemic disease.
• Hemostasis is not achieved within 5 minutes of pulp amputation, by direct contact with a wet cotton pellet before the material placement.
• The remaining radicular tissue was non-vital (with suppuration or purulence necrosis).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: NeoPutty MTA Pulpotomy; Participants will receive vital pulpotomy of mandibular primary molars using NeoPutty MTA as the pulpotomy medicament, followed by restoration with glass ionomer cement and stainless steel crown.	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.
Active Comparator: Arm B: Formocresol Pulpotomy; Participants will receive vital pulpotomy of mandibular primary molars using formocresol (1:5 dilution of Buckley's formocresol) applied with cotton pellet, followed by reinforced zinc oxide eugenol, glass ionomer cement, and 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Presence or absence of spontaneous postoperative pain reported by the child/parent after pulpotomy treatment.	1 week postoperatively, 3 months, 6 months, 9 months and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain on percussion	Description: Presence or absence of pain on percussion during clinical follow-up visits.	3 months, 6 months, 9 months and 12 months
Presence of sinus tract, fistula or abscess	Description: Clinical evaluation for presence of swelling, abscess, or sinus/fistulous tract related to the treated tooth.	3 months, 6 months, 9 months and 12 months
Tooth mobility	Description: Tooth mobility assessed clinically using a mobility scoring system ranges from 0-3 were (score 0 the best) indicates no mobility and (score 3 the worst) indicates vertical and horizontal mobility.	3 months, 6 months, 9 months and 12 months
Widening of Periodontal Ligament Space	Radiographic evidence of widening of the periodontal ligament space assessed using standardized periapical radiographs. Recorded as Present / Absent.	6 months and 12 months after treatment
Internal and External Root Resorption	Radiographic evidence of internal or external root resorption observed on periapical radiographs. Recorded as Present / Absent.	6 months and 12 months after treatment
Furcal or Periapical Radiolucency	Presence of radiolucent lesion in the furcation or periapical area detected on standardized periapical radiographs. Recorded as Present / Absent.	6 months and 12 months after treatment

Collaborators and Investigators

• Sponsor: October University for Modern Sciences and Arts

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Pulpotomy; Mineral Trioxide Aggregate; Formocresol; Vital Pulp Therapy; Stainless Steel Crown; Deep Caries in Primary Molars; NeoPutty MTA
• Additional Relevant MeSH Terms: formocresol
• Other Study ID Numbers: Ahmed MSA University

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No