Deep Caries in Primary Molars
Conditions
Keywords
Deep Caries in Primary Molars, NeoPutty MTA, Mineral Trioxide Aggregate, Formocresol, Vital Pulp Therapy, Pulpotomy, Stainless Steel Crown
Brief summary
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
DRUGNeoPutty 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.
DRUGFormocresol
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.
Sponsors
October University for Modern Sciences and Arts
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
the statistician will be blinded
Eligibility
Sex/Gender
ALL
Age
4 Years to 9 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain on percussion | 3 months, 6 months, 9 months and 12 months | Description: Presence or absence of pain on percussion during clinical follow-up visits. |
| Presence of sinus tract, fistula or abscess | 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. |
| Tooth mobility | 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. |
| Widening of Periodontal Ligament Space | 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. |
| Internal and External Root Resorption | 6 months and 12 months after treatment | Radiographic evidence of internal or external root resorption observed on periapical radiographs. Recorded as Present / Absent. |
| Furcal or Periapical Radiolucency | 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. |
Countries
Egypt
Contacts
CONTACTAhmed Shawky, bachelor of dentistry
Outcome results
None listed