An interventional study of NeoPUTTY and Mineral Trioxide Aggregate (MTA) in Irreversible Pulpitis and Pulpotomy, sponsored by Postgraduate Institute of Dental Sciences Rohtak. Completed at 1 site in India. Open to participants aged 9 Years to 14 Years. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by Postgraduate Institute of Dental Sciences Rohtak · Not applicable, Interventional, and Treatment
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.
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.
Postgraduate Institute of Dental Sciences Rohtak is the lead sponsor of 209 studies on the registry; 71 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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)
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
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
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.
Time frame: 1 month, 3 months, 6 months, and 12 months (clinical); 6 months and 12 months (radiographic)
Postoperative pain
Pain assessed using Visual Analogue Scale (VAS) scored 0 to 10
Time frame: 24 hours postoperatively
Intraoperative haemostasis time
Time in minutes taken to achieve haemostasis following coronal pulp amputation using sodium hypochlorite moistened cotton pellets
Time frame: Intraoperative
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Postgraduate Institute of Dental Sciences Rohtak