3Mixtatin and MTA Vital Pulpotomy in Primary Molars

Phase 1

Not yet recruiting

• Conditions: Pulp Disease, Dental; Deciduous Teeth
• Interventions: Drug: 3 mixtatin pulpotomy; Drug: MTA pulpotomy

• Registration Number: NCT06478940
• Lead Sponsor: Cairo University

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 .

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-23
• Study First Submitted QC: 2024-06-23
• Last Update Submitted: 2024-06-23
• Study First Posted: 2024-06-27
• Last Update Posted: 2024-06-27
• Study Start: 2024-08-01
• Primary Completion: 2025-08-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 )