3Mixtatin and MTA Vital Pulpotomy in Primary Molars

Cairo University (CU)

Status and phase: Not yet enrolling; Phase 1

Conditions: Pulp Disease, Dental; Deciduous Teeth

Treatments: Drug: MTA pulpotomy; Drug: 3 mixtatin pulpotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06478940

3Mixtatin and MTA pulpotomy

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 50 estimated patients

Sex: All

Ages: 4 to 8 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

MTA pulpotomy

Active Comparator group

Description:

pulpotomy with MTA applied in the vital pulp therapy

Treatment:

Drug: MTA pulpotomy

3 Mixtatin pulpotomy

Experimental group

Description:

pulpotomy with 3 mixtatin (triple antibiotic paste of (Metronidazole, cefixime, and Ciprofloxacin mixed with simvastatin ) applied in the vital pulp therapy

Treatment:

Drug: 3 mixtatin pulpotomy