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

NCT07702942 | Completed FDA Device

• 1 other identifier: PGIDS/BHRC/24/48
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

NeoPUTTY; MTA; Pulpotomy; Pediatric dentistry; Vital pulp therapy; Permanent molars; Irreversible Pulpitis

Outcome Measures

Primary Outcomes (1)

• Clinical and radiographic success of full pulpotomy

  Clinical success was defined as absence of spontaneous pain, tenderness to percussion, pathological mobility, sinus tract, and soft tissue swelling. Radiographic success was defined as absence of periapical radiolucency, internal or external pathological root resorption, and furcation radiolucency. Overall success required fulfillment of both clinical and radiographic criteria simultaneously at each evaluation timepoint.

  1 month, 3 months, 6 months, and 12 months (clinical); 6 months and 12 months (radiographic)

Secondary Outcomes (2)

• Postoperative pain

  24 hours postoperatively

• Intraoperative haemostasis time

  Intraoperative

Study Arms (2)

Group 1: NeoPUTTY

EXPERIMENTAL

Full pulpotomy using NeoPUTTY (NuSmile Ltd., Houston, TX, USA), a premixed calcium silicate bioceramic material, applied as a 2 to 3 mm layer over radicular pulp stumps following complete coronal pulp amputation, haemostasis with 5 percent sodium hypochlorite, and immediate definitive composite restoration

Device: NeoPUTTY

Group 2: MTA

ACTIVE COMPARATOR

Full pulpotomy using 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, haemostasis with 5 percent sodium hypochlorite, and immediate definitive composite restoration

Device: Mineral Trioxide Aggregate (MTA)

Interventions

NeoPUTTY DEVICE

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

Group 1: NeoPUTTY

Mineral Trioxide Aggregate (MTA) DEVICE

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

Group 2: MTA

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Systemically healthy children aged 9 to 14 years with mature permanent maxillary or mandibular molars presenting with symptomatic irreversible pulpitis, characterized by spontaneous pain, lingering thermal pain, or referred pain of moderate or severe intensity per Wolters classification
• Teeth with complete root development and closed apices confirmed radiographically, with adequate remaining coronal tooth structure for definitive restoration
• Deep or extremely deep carious lesions with risk of or unavoidable pulp exposure during operative treatment
• Teeth with normal periapical radiographic appearance or mild periapical changes limited to slight widening of periodontal ligament space or subtle trabecular alterations without frank periapical radiolucency or loss of lamina dura continuity
• Teeth free from advanced periodontal disease
• Parents or legal guardians willing to provide written informed consent and comply with follow-up schedule

You may not qualify if:

• Children with systemic diseases or known hypersensitivity to any material used in the study
• Teeth with immature root development or incomplete apical closure
• Non-restorable teeth with inadequate remaining coronal tooth structure
• Teeth with pathological mobility, sinus tract, or soft tissue swelling
• Established apical periodontitis with frank periapical radiolucency, furcation involvement, or loss of lamina dura continuity on radiographic examination
• Evidence of internal or external pathological root resorption
• Failure to achieve haemostasis within 25 minutes of coronal pulp amputation
• Lack of parental or guardian consent or unwillingness to comply with follow-up visits

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute of Dental Sciences, Rohtak

Rohtak, Haryana, 124001, India

Location

Study Officials

• Dr. Shiwani Chawla

  Post Graduate Institute of Dental Sciences, Rohtak

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start: May 19, 2024
• Primary Completion: November 20, 2025
• Study Completion: November 20, 2025
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)