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Comparative Evaluation of NeoPUTTY and MTA Pulpotomy in Mature Permanent Molars With Irreversible Pulpitis

NCT07702942 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-07-15

No results posted yet for this study

Summary

When a permanent back tooth develops severe nerve inflammation that cannot heal on its own, a procedure called pulpotomy can be performed to remove the diseased nerve tissue from the crown of the tooth while preserving the healthy roots. This helps save the tooth and avoid extraction. Two materials are commonly used to cover the remaining nerve tissue after pulpotomy: Mineral Trioxide Aggregate (MTA), which is considered the gold standard, and NeoPUTTY, a newer premixed calcium silicate material that is easier to use and requires no mixing.

This study was conducted to compare the success of NeoPUTTY and MTA when used for full pulpotomy in mature permanent back teeth of children aged 9 to 14 years who had severe toothache due to irreversible nerve inflammation. Forty-six children were enrolled and randomly assigned to receive either NeoPUTTY or MTA after complete removal of the nerve tissue from the crown of the tooth. All teeth were restored with a definitive filling in the same visit. Children were followed up at 1, 3, 6, and 12 months to assess clinical success, and radiographic assessment was performed at 6 and 12 months. Pain after the procedure was recorded at 24 hours and the time taken to stop bleeding during the procedure was also recorded.

The study aimed to determine whether NeoPUTTY offers comparable results to MTA as a pulpotomy material in permanent teeth of children, which could help guide clinical decision-making in pediatric dental practice.

Conditions

  • Irreversible Pulpitis
  • Pulpotomy

Interventions

DEVICE

NeoPUTTY

Premixed calcium silicate bioceramic material (NeoPUTTY, NuSmile Ltd., Houston, TX, USA) applied as a 2 to 3 mm layer over radicular pulp stumps following complete coronal pulp amputation under rubber dam isolation

DEVICE

Mineral Trioxide Aggregate (MTA)

White mineral trioxide aggregate (MTA Angelus, Angelus Odonto, Londrina, Brazil) applied as a 2 to 3 mm layer over radicular pulp stumps following complete coronal pulp amputation under rubber dam isolation

Sponsors & Collaborators

  • Postgraduate Institute of Dental Sciences Rohtak

    lead OTHER

Principal Investigators

  • Dr. Shiwani Chawla · Post Graduate Institute of Dental Sciences, Rohtak

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-19
Primary Completion
2025-11-20
Completion
2025-11-20
FDA Device
Yes

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07702942 on ClinicalTrials.gov