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Completed
NCT07702942
Comparative Evaluation of NeoPUTTY and MTA Pulpotomy in Mature Permanent Molars With Irreversible Pulpitis
Conditions: Irreversible Pulpitis, Pulpotomy
Sex: All
Ages: 9 Years – 14 Years
Healthy volunteers: No
Phase: NA
Enrollment: 46
Sponsor: Postgraduate Institute of Dental Sciences Rohtak
Location: Post Graduate Institute of Dental Sciences, Rohtak Rohtak Haryana
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07702942). StuddyBuddy aggregates publicly available trial information.