An interventional study of NeoPutty MTA and Formocresol in Deep Caries in Primary Molars, sponsored by October University for Modern Sciences and Arts. Not yet recruiting at 1 site in Egypt. Open to participants aged 4 Years to 9 Years. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by October University for Modern Sciences and Arts · Not applicable, Interventional, and Treatment
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.
Children with asymptomatic decayed primary mandibular molar(s).
Exclusion Criteria:
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.
Drug: NeoPutty MTA
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.
Drug: Formocresol
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.
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.
Postoperative pain
Presence or absence of spontaneous postoperative pain reported by the child/parent after pulpotomy treatment.
Time frame: 1 week postoperatively, 3 months, 6 months, 9 months and 12 months
Pain on percussion
Description: Presence or absence of pain on percussion during clinical follow-up visits.
Time frame: 3 months, 6 months, 9 months and 12 months
Presence of sinus tract, fistula or abscess
Description: Clinical evaluation for presence of swelling, abscess, or sinus/fistulous tract related to the treated tooth.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months and 12 months after treatment
Plan to share: No
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This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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October University for Modern Sciences and Arts