Irreversible PulpitisNCT07702942
Comparative Evaluation of NeoPUTTY and MTA Pulpotomy in Mature Permanent Molars With Irreversible Pulpitis
A study testing NeoPUTTY and Mineral Trioxide Aggregate (MTA) in people with Irreversible Pulpitis and Pulpotomy, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 14 years
- Conditions the study is for
- Irreversible Pulpitis, Pulpotomy
- What is being tested?
- NeoPUTTY and Mineral Trioxide Aggregate (MTA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteIndia
- Study dates
- 19 May 2024to 20 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Post Graduate Institute of Dental Sciences, Rohtak
Rohtak, Haryana, 124001
About this study
Official title: 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.
Read the 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.
- Conditions
- Irreversible Pulpitis, Pulpotomy
- Being tested
- NeoPUTTY, Mineral Trioxide Aggregate (MTA)
- Keywords
- NeoPUTTY, MTA, Pulpotomy, Pediatric dentistry, Vital pulp therapy, Permanent molars, Irreversible Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeoPUTTYDevice
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
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Mineral Trioxide Aggregate (MTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month, 3 months, 6 months, and 12 months (clinical); 6 months and 12 months (radiographic)
Secondary outcomes (2)
Postoperative pain
Pain assessed using Visual Analogue Scale (VAS) scored 0 to 10
Measured: 24 hours postoperatively
Intraoperative haemostasis time
Time in minutes taken to achieve haemostasis following coronal pulp amputation using sodium hypochlorite moistened cotton pellets
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start19 May 2024
- Primary completion20 Nov 2025
- Study completion20 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irreversible PulpitisStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Shiwani Chawla, Principal investigator, Post Graduate Institute of Dental Sciences, Rohtak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702942
- Sponsor's protocol ID
- PGIDS/BHRC/24/48
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Chawla S, Singhal R, Namdev R, Kumari C, Chhanna K. Comparative evaluation of NeoPUTTY and mineral trioxide aggregate for full pulpotomy in mature permanent molars with irreversible pulpitis: a randomized clinical study. Biomater Investig Dent. 2026 Aug 13;13:46677. doi: 10.2340/biid.v13.46677. eCollection 2026.
PubMed 42614935
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Success of NeoPUTTY Pulpotomy and MTA Pulpotomy in Mature Permanent Molars With Irreversible Pulpitis: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT07702942
- Acronym / sponsor ID
- PGIDS/BHRC/24/48
- Conditions
- Irreversible Pulpitis, Pulpotomy
- Keywords
- NeoPUTTY, MTA, Pulpotomy, Pediatric dentistry, Vital pulp therapy, Permanent molars, Irreversible Pulpitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 19 May 2024 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: NeoPUTTY | Experimental | Device: NeoPUTTYFull 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 |
| Group 2: MTA | Active comparator | Device: Mineral Trioxide Aggregate (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 |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeoPUTTYPremixed 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 | Group 1: NeoPUTTY |
| 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 | Device | Group 2: MTA |
Primary outcome
Clinical and radiographic success of full pulpotomy
Time frame: 1 month, 3 months, 6 months, and 12 months (clinical); 6 months and 12 months (radiographic)
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.
2 secondary outcomes
Postoperative pain
Time frame: 24 hours postoperatively
Intraoperative haemostasis time
Time frame: Intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Derived from this study: PubMed 42614935Chawla S, Singhal R, Namdev R, Kumari C, Chhanna K. Comparative evaluation of NeoPUTTY and mineral trioxide aggregate for full pulpotomy in mature permanent molars with irreversible pulpitis: a randomized clinical study. Biomater Investig Dent. 2026 Aug 13;13:46677. doi: 10.2340/biid.v13.46677. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Shiwani Chawla principal investigator
Post Graduate Institute of Dental Sciences, Rohtak
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeoPUTTY and Mineral Trioxide Aggregate (MTA) in people with Irreversible Pulpitis and Pulpotomy, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical and radiographic success of full pulpotomy (time frame: 1 month, 3 months, 6 months, and 12 months (clinical); 6 months and 12 months (radiographic)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07702942, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.