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

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.

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