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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: NeoPutty MTA Pulpotomy | Experimental | Participants will receive vital pulpotomy of mandibular primary molars using NeoPutty MTA as the pulpotomy medicament, followed by restoration with glass ionomer cement and stainless steel crown. |
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| Arm B: Formocresol Pulpotomy | Active Comparator | Participants will receive vital pulpotomy of mandibular primary molars using formocresol (1:5 dilution of Buckley's formocresol) applied with cotton pellet, followed by reinforced zinc oxide eugenol, glass ionomer cement, and stainless steel crown. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeoPutty MTA | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | Presence or absence of spontaneous postoperative pain reported by the child/parent after pulpotomy treatment. | 1 week postoperatively, 3 months, 6 months, 9 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain on percussion | Description: Presence or absence of pain on percussion during clinical follow-up visits. | 3 months, 6 months, 9 months and 12 months |
| Presence of sinus tract, fistula or abscess |
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Inclusion Criteria:
Children with asymptomatic decayed primary mandibular molar(s).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Shawky, bachelor of dentistry | Contact | +201124465202 | ahmed.shawky3@msa.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| October university for modern sciences and arts | Giza | Giza Governorate | 12116 | Egypt |
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the statistician will be blinded
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| Formocresol | Drug | 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. |
|
Description: Clinical evaluation for presence of swelling, abscess, or sinus/fistulous tract related to the treated tooth.
| 3 months, 6 months, 9 months and 12 months |
| Tooth mobility | Description: Tooth mobility assessed clinically using a mobility scoring system ranges from 0-3 were (score 0 the best) indicates no mobility and (score 3 the worst) indicates vertical and horizontal mobility. | 3 months, 6 months, 9 months and 12 months |
| Widening of Periodontal Ligament Space | Radiographic evidence of widening of the periodontal ligament space assessed using standardized periapical radiographs. Recorded as Present / Absent. | 6 months and 12 months after treatment |
| Internal and External Root Resorption | Radiographic evidence of internal or external root resorption observed on periapical radiographs. Recorded as Present / Absent. | 6 months and 12 months after treatment |
| Furcal or Periapical Radiolucency | Presence of radiolucent lesion in the furcation or periapical area detected on standardized periapical radiographs. Recorded as Present / Absent. | 6 months and 12 months after treatment |
| ID | Term |
|---|---|
| C031025 | formocresol |
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