Clinical and Radiographic Assessment of Neo Putty MTA Versus Formocresol Used in Vital Pulpotomy of Mandibular Primary Molars
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NeoPutty MTA, Formocresol.
- Who it may be relevant to
- Registry conditions: Deep Caries in Primary Molars. Basic parameters: 4 years — 9 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical and Radiographic Assessment of Neo Putty MTA Versus Formocresol Used in Vital Pulpotomy of Mandibular Primary Molars: A Randomized Clinical Trial
Overview
This randomized clinical trial aims to evaluate the clinical and radiographic success of NeoPutty MTA compared to formocresol in vital pulpotomy of mandibular primary molars in children aged 4 to 9 years. Participants will be randomly allocated into two groups (1:1) to receive pulpotomy using either NeoPutty MTA or formocresol, followed by restoration with stainless steel crowns. Clinical and radiographic outcomes will be assessed during follow-up visits.
Detailed description
Pulpotomy is a commonly performed vital pulp therapy in pediatric dentistry. Formocresol has been widely used due to its high clinical success; however, concerns exist regarding its potential toxicity. NeoPutty MTA is a premixed bioceramic material introduced as an alternative pulpotomy agent with improved handling properties and bioactivity. This randomized parallel-group clinical trial will compare NeoPutty MTA versus formocresol in vital pulpotomy of mandibular primary molars. Children aged 4-9 years presenting with asymptomatic carious mandibular primary molars will be recruited from the Pediatric Dentistry Department, Faculty of Dentistry, MSA University. Eligible teeth will undergo standardized pulpotomy procedures, restoration with glass ionomer cement, and stainless steel crowns. Clinical and radiographic follow-up will be performed at scheduled intervals to evaluate success and failure outcomes.
Interventions
- Drug NeoPutty MTA
NeoPutty MTA (NuSmile) will be placed directly over the radicular pulp stumps after hemostasis, then the tooth will be sealed with resin-modified glass ionomer cement and restored with stainless steel crown. - Drug Formocresol
A sterile cotton pellet lightly moistened with a 1:5 dilution of Buckley's formocresol will be placed against the pulp stumps for 3-5 minutes, then removed. Reinforced zinc oxide eugenol will be placed, followed by glass ionomer cement and stainless steel crown restoration.
Primary outcome measures
- Postoperative pain [Time frame: 1 week postoperatively, 3 months, 6 months, 9 months and 12 months]
Secondary outcome measures (6)
- Pain on percussion [Time frame: 3 months, 6 months, 9 months and 12 months]
- Presence of sinus tract, fistula or abscess [Time frame: 3 months, 6 months, 9 months and 12 months]
- Tooth mobility [Time frame: 3 months, 6 months, 9 months and 12 months]
- Widening of Periodontal Ligament Space [Time frame: 6 months and 12 months after treatment]
- Internal and External Root Resorption [Time frame: 6 months and 12 months after treatment]
- Furcal or Periapical Radiolucency [Time frame: 6 months and 12 months after treatment]
Eligibility criteria
Inclusion criteria
Children with asymptomatic decayed primary mandibular molar(s).
- Patient and parent showing cooperation and compliance.
- Children 4-9 years old.
- Vital carious primary(s) with complete root formation.
- Asymptomatic teeth or without clinical symptoms of spontaneous pain.
- No clinical evidence of pulp degeneration like the history of spontaneous or nocturnal pain, tenderness to percussion, pathologic tooth mobility, swelling, or fistulous tract.
- Both genders will be included.
- No radiographic evidence of pulp degeneration such as internal root resorption, external root resorption, or furcal radiolucency.
- Presence of two thirds of the root.
- Teeth that can be restored.
- Children with prior parental consent.
Exclusion criteria
- History of any systemic disease.
- Hemostasis is not achieved within 5 minutes of pulp amputation, by direct contact with a wet cotton pellet before the material placement.
- The remaining radicular tissue was non-vital (with suppuration or purulence necrosis).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- October university for modern sciences and arts — Giza
Identifiers
NCT: NCT07437794 · Ahmed MSA University