Pulp Disease, Dental, Deciduous Teeth
Conditions
Keywords
pulpotomy - vital pulp therapy, primary molars- baby teeth
Brief summary
The aim of the study is to evaluate clinical and radiographic success of using 3Mixtain versus mineral trioxide aggregate in pulpotomy of deeply carious Primary molars.
Detailed description
Due to the complexity of the root canal microbiome, it is doubtful that they can be treated properly with a single antibiotic. Accordingly, a combination of multiple antibiotics seemed to be essential to diminish different types of pathogenic bacteria. Recently, a combination of three antibiotics (Metronidazole, cefixime, and Ciprofloxacin) along with Statins (new bio-inductive materials in regenerative dentistry) has shown promising results in primary teeth pulp therapy. Statin components have an anti-inflammatory impact on pulp tissue by lowering the amount of interleukin-6 and interleukin-8. They also decrease osteoclastic processes and strengthen osteoblastic processes. Thus, they promote bone regeneration and dentin formation by enhancing odontoblastic activity. Several studies have shown a clinical and radiographic success rate of 3Mixtatin with inconsistent results. Some randomized controlled Trials (RCTs) showed that MTA had a comparable result with 3Mixtatin, while others reported that 3Mixtatin might be an alternative for MTA due to its higher overall success rate. 3Mixtatin is considered as a novel material with successful outcomes. Owing to limited availability of data in researches and in order to reach a conclusive results our study aims to evaluate clinical and radiographic success of using 3Mixtain versus mineral trioxide aggregate in pulpotomy of deeply carious Primary molars .
Interventions
DRUG3 mixtatin pulpotomy
pulp treatment with applying 3mixture of antibiotic (Metronidazole, cefixime, and Ciprofloxacin) along with simvastatin
DRUGMTA pulpotomy
pulp treatment with applying MTA
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
* • Children 4-8 years old * Vital deeply carious primary molars. * No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of the vestibule. * Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test. * Patient and parent showing cooperation and compliance.
Exclusion criteria
* • Uncooperative children to avoid time waste and attrition bias. * Unrestorable molars * Sign of radiolucency in periapical or furcation area * Widening of PDL space or loss of lamina dura continuity * Evidence of internal/external pathologic root resorption * During operative procedure, when hemorrhage control is not achievable after pulpotomy. * Children with systemic disease as some systemic diseases may have effect on the outcome. * Unable to attend follow-up visits to avoid attrition bias by decreasing number of drop off cases. * Refusal of participation as the parent of child has the authority of participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical success Clinical success clinical success | 1 week , 3 months , 6 months , 9 months and 12 months | absence of postoperative pain,Absence of pain on percussion,Absence of Swelling and Absence of Sinus or fistula |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic success radiographic success | 3 months , 6 months , 12 months | Absence of any adverse radiographic findings (Periodontal membrane space widening, bone resorption, pulp stones, internal or external root resorption ) |
Contacts
Primary ContactSally A kotb, PHD researcher
Backup ContactEslam M Mahdy
Outcome results
None listed