3Mixtatin and MTA Vital Pulpotomy in Primary Molars

June 23, 2024 updated by: Sally Ahmed Kotb, Cairo University

Clinical and Radiographic Evaluation of 3Mixtatin Versus MTA Used as Pulpotomy Agents in Vital Primary Molars: A Randomized Clinical Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: MTA pulpotomy
pulpotomy with MTA applied in the vital pulp therapy
Drug: MTA pulpotomy
pulp treatment with applying MTA
Experimental: 3 Mixtatin pulpotomy
pulpotomy with 3 mixtatin (triple antibiotic paste of (Metronidazole, cefixime, and Ciprofloxacin mixed with simvastatin ) applied in the vital pulp therapy
Drug: 3 mixtatin pulpotomy
pulp treatment with applying 3mixture of antibiotic (Metronidazole, cefixime, and Ciprofloxacin) along with simvastatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical success Clinical success clinical success
Time Frame: 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
1 week , 3 months , 6 months , 9 months and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic success radiographic success
Time Frame: 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 )
3 months , 6 months , 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Randa y Abd Al Gawad, professor, professor of pediatric dentistry and dental public health, faculty of dentistry, Cairo University
  • Study Chair: Yasmin M Yousry, Associate professor, Assistant Professor of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

June 23, 2024

First Submitted That Met QC Criteria

June 23, 2024

First Posted (Actual)

June 27, 2024

Study Record Updates

Last Update Posted (Actual)

June 27, 2024

Last Update Submitted That Met QC Criteria

June 23, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3Mixtatin and MTA pulpotomy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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