October university for modern sciences and arts
Giza, Giza Governorate, 12116, Egypt
NCT Number: NCT07437794
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.
Trial opening soon.
Get Notified4 year–9 year
All sexes
Interventional
Not applicable
Giza, Giza Governorate, 12116, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Children with asymptomatic decayed primary mandibular molar(s).
Exclusion criteria
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.
Time frame: 1 week postoperatively, 3 months, 6 months, 9 months and 12 months
Presence or absence of spontaneous postoperative pain reported by the child/parent after pulpotomy treatment.
Time frame: 3 months, 6 months, 9 months and 12 months
Description: Presence or absence of pain on percussion during clinical follow-up visits.
Time frame: 3 months, 6 months, 9 months and 12 months
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
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: 6 months and 12 months after treatment
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
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
Presence of radiolucent lesion in the furcation or periapical area detected on standardized periapical radiographs. Recorded as Present / Absent.
Contact information is provided by the study sponsor or research team.
October University for Modern Sciences and Arts
Other
Clinical and Radiographic Assessment of Neo Putty MTA Versus Formocresol Used in Vital Pulpotomy of Mandibular Primary Molars: A Randomized Clinical Trial
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