Comparative Evaluation of NeoPUTTY and MTA Pulpotomy in Mature Permanent Molars With Irreversible… (NCT07702942) | Clinical Trial Compass
CompletedNot Applicable
Comparative Evaluation of NeoPUTTY and MTA Pulpotomy in Mature Permanent Molars With Irreversible Pulpitis
India46 participantsStarted 2024-05-19
Plain-language 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.
Who can participate
Age range
9 Years – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical and radiographic success of full pulpotomy
Timeframe: 1 month, 3 months, 6 months, and 12 months (clinical); 6 months and 12 months (radiographic)
Trial details
NCT IDNCT07702942
SponsorPostgraduate Institute of Dental Sciences Rohtak