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

Comparative Evaluation of Success of NeoPUTTY Pulpotomy and MTA Pulpotomy in Mature Permanent Molars With Irreversible Pulpitis: A Randomized Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: Irreversible Pulpitis; Pulpotomy
• Intervention / Treatment: Device: NeoPUTTY; Device: Mineral Trioxide Aggregate (MTA)

Detailed Description

Irreversible pulpitis in mature permanent teeth presents a clinical challenge in pediatric dentistry, as conventional treatment options include either root canal therapy or extraction. Full pulpotomy, involving complete removal of the coronal pulp while preserving vital radicular pulp tissue, has emerged as a biologically conservative alternative supported by growing evidence. The success of pulpotomy depends critically on the pulp capping material used, which must provide an adequate seal, promote dentinal bridge formation, and maintain radicular pulp vitality.

Mineral Trioxide Aggregate (MTA) has been extensively studied and is considered the gold standard pulpotomy material due to its biocompatibility, sealing ability, and capacity to induce hard tissue formation. However, its clinical use is limited by the need for manual mixing, long setting time, handling difficulties, and high cost. NeoPUTTY (NuSmile Ltd., Houston, TX, USA) is a premixed, ready-to-use calcium silicate bioceramic material based on the same tricalcium and dicalcium silicate chemistry as MTA. It requires no mixing, is immediately wash-out resistant, and offers improved handling characteristics. Previous studies have evaluated NeoPUTTY in primary teeth, but evidence in mature permanent teeth was limited at the time this study was initiated.

This randomized parallel-group clinical trial was conducted at the Department of Pedodontics and Preventive Dentistry, Post Graduate Institute of Dental Sciences (PGIDS), Rohtak, India, a government dental institution under Pt. B.D. Sharma University of Health Sciences, Haryana. The study was approved by the Biomedical and Health Research Ethics Committee, PGIDS, Rohtak (Approval No. PGIDS/BHRC/24/48, dated 14/05/2024) and conducted in accordance with the Declaration of Helsinki and ICMR guidelines. Written informed consent was obtained from parents or legal guardians of all participating children prior to enrollment.

Participants were randomly allocated in a 1:1 ratio using the lottery method, with allocation concealment achieved through sequentially numbered opaque sealed envelopes. All procedures were performed by a single trained operator under rubber dam isolation. After caries removal and access cavity preparation, complete coronal pulp amputation was performed using a high-speed diamond bur under copious irrigation. Haemostasis was achieved using sterile cotton pellets moistened with 5 percent sodium hypochlorite solution applied for up to 5 minutes. Cases failing to achieve haemostasis within 25 minutes were excluded. The pulpotomy material (NeoPUTTY or MTA Angelus, Londrina, Brazil) was then applied as a 2 to 3 mm thick layer over the pulp stumps, followed by a glass ionomer cement base and definitive composite resin restoration placed in the same visit. Outcome assessors were blinded to group allocation and radiographs were anonymised prior to evaluation.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • Post Graduate Institute of Dental Sciences, Rohtak

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: NeoPUTTY; 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; 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
Active Comparator: Group 2: MTA; 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); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Pain assessed using Visual Analogue Scale (VAS) scored 0 to 10	24 hours postoperatively
Intraoperative haemostasis time	Time in minutes taken to achieve haemostasis following coronal pulp amputation using sodium hypochlorite moistened cotton pellets	Intraoperative

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak
• Investigators: Principal Investigator: Dr. Shiwani Chawla, Post Graduate Institute of Dental Sciences, Rohtak

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2024
• Primary Completion (Actual): November 20, 2025
• Study Completion (Actual): November 20, 2025

Study Registration Dates

• First Submitted: July 8, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: MTA; Pediatric dentistry; Irreversible Pulpitis; Pulpotomy; Vital pulp therapy; Permanent molars; NeoPUTTY
• Other Study ID Numbers: PGIDS/BHRC/24/48

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: Yes
• product manufactured in and exported from the U.S.: Yes