NCT07437794

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

1 month

First QC Date

February 23, 2026

Last Update Submit

February 23, 2026

Conditions

Deep Caries in Primary Molars

Keywords

Deep Caries in Primary MolarsNeoPutty MTAMineral Trioxide AggregateFormocresolVital Pulp TherapyPulpotomyStainless Steel Crown

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Pain on percussion

    3 months, 6 months, 9 months and 12 months

  • Presence of sinus tract, fistula or abscess

    3 months, 6 months, 9 months and 12 months

  • Tooth mobility

    3 months, 6 months, 9 months and 12 months

  • Widening of Periodontal Ligament Space

    6 months and 12 months after treatment

  • Internal and External Root Resorption

    6 months and 12 months after treatment

  • +1 more secondary outcomes

Study Arms (2)

Arm A: NeoPutty MTA Pulpotomy

EXPERIMENTAL

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

Arm B: Formocresol Pulpotomy

ACTIVE COMPARATOR

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

Interventions

NeoPutty MTADRUG

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.

Arm A: NeoPutty MTA Pulpotomy
FormocresolDRUG

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.

Arm B: Formocresol Pulpotomy

Eligibility Criteria

Age4 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

October university for modern sciences and arts

Giza, Giza Governorate, 12116, Egypt

Location

MeSH Terms

Interventions

formocresol

Central Study Contacts

Ahmed Shawky, bachelor of dentistry

CONTACT

+201124465202ahmed.shawky3@msa.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
the statistician will be blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
general practitioner at ministry of health in Egypt

Study Record Dates

First Submitted

February 23, 2026

First Posted

February 27, 2026

Study Start

March 1, 2026

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)