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Pulp Disease, DentalPhase 1NCT06478940

3Mixtatin and MTA Vital Pulpotomy in Primary Molars

A Phase 1 study testing 3 mixtatin pulpotomy and MTA pulpotomy in people with Pulp Disease, Dental and Deciduous Teeth, run by Cairo University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 8 yearsHealthy volunteers can take part
Conditions the study is for
Pulp Disease, Dental, Deciduous Teeth
What is being tested?
3 mixtatin pulpotomy and MTA pulpotomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
1 Aug 2024to 1 Sep 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 8 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • • 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.

Who cannot join

  • • 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.
Show all 9Show fewer
  • 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 locations and contacts

No sites are listed yet.

Sally A kotb, PHD researcher contact

00201001656502

sallyqutb9933@gmail.com

Eslam M Mahdy contact

00201143683135

eslam.mahdy@dentistry.cu.edu.eg

About this study

Official title: 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.

Read the 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 .

Being tested
3 mixtatin pulpotomy, MTA pulpotomy
Keywords
pulpotomy - vital pulp therapy, primary molars- baby teeth
Medical subject headings
Dental Pulp Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3 mixtatin pulpotomyDrug

    pulp treatment with applying 3mixture of antibiotic (Metronidazole, cefixime, and Ciprofloxacin) along with simvastatin

  • MTA pulpotomyDrug

    pulp treatment with applying MTA

Study groups in NCT06478940
Study groupRoleWhat they receive
MTA pulpotomyActive comparatorpulpotomy with MTA applied in the vital pulp therapy
Receives: Drug: MTA pulpotomy
3 Mixtatin pulpotomyExperimentalpulpotomy with 3 mixtatin (triple antibiotic paste of (Metronidazole, cefixime, and Ciprofloxacin mixed with simvastatin ) applied in the vital pulp therapy
Receives: Drug: 3 mixtatin pulpotomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical success Clinical success clinical success

    absence of postoperative pain,Absence of pain on percussion,Absence of Swelling and Absence of Sinus or fistula

    Measured: 1 week , 3 months , 6 months , 9 months and 12 months

Secondary outcomes (1)

  1. Radiographic success radiographic success

    Absence of any adverse radiographic findings (Periodontal membrane space widening, bone resorption, pulp stones, internal or external root resorption )

    Measured: 3 months , 6 months , 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2024
  2. Study start1 Aug 2024 (estimated)
  3. Primary completion1 Aug 2025 (estimated)
  4. Study completion1 Sep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06478940
Sponsor's protocol ID
3Mixtatin and MTA pulpotomy
Status last verified
Jun 2024
First submitted
23 Jun 2024
Last updated
27 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Almarji W, Laflouf M, Tolibah YA. Evaluation of the modified 3Mix-Simvastatin combination in non-instrumental endodontic therapy of necrotic primary molars: A two-arm randomized controlled trial. Clin Exp Dent Res. 2024 Apr;10(2):e860. doi: 10.1002/cre2.860.

    PubMed 38433296

  • Zarabadi MS, Firoozi P, Basir Shabestari S, Maleki A, Nazemi Salman B. 3Mixtatin versus MTA in pulp therapy of primary teeth: a systematic review and meta-analysis of current randomized controlled trials. Evid Based Dent. 2024 Jun;25(2):111-112. doi: 10.1038/s41432-024-00987-8. Epub 2024 Mar 6.

    PubMed 38448571

  • Mushtaq A, Nangia T, Goswami M. Comparative Evaluation of the Treatment Outcomes of Pulpotomy in Primary Molars Using Mineral Trioxide Aggregate and 3Mixtatin: A Randomized Clinical Trial. Int J Clin Pediatr Dent. 2023 Nov-Dec;16(6):810-815. doi: 10.5005/jp-journals-10005-2720.

    PubMed 38344366

  • Chak RK, Singh RK, Mutyala J, Killi NK. Clinical Radiographic Evaluation of 3Mixtatin and MTA in Primary Teeth Pulpotomies: A Randomized Controlled. Int J Clin Pediatr Dent. 2022;15(Suppl 1):S80-S86. doi: 10.5005/jp-journals-10005-2216.

    PubMed 35645497

  • Aminabadi NA, Huang B, Samiei M, Agheli S, Jamali Z, Shirazi S. A Randomized Trial Using 3Mixtatin Compared to MTA in Primary Molars with Inflammatory Root Resorption: A Novel Endodontic Biomaterial. J Clin Pediatr Dent. 2016;40(2):95-102. doi: 10.17796/1053-4628-40.2.95.

    PubMed 26950808

  • Asl Aminabadi N, Satrab S, Najafpour E, Samiei M, Jamali Z, Shirazi S. A randomized trial of direct pulp capping in primary molars using MTA compared to 3Mixtatin: a novel pulp capping biomaterial. Int J Paediatr Dent. 2016 Jul;26(4):281-90. doi: 10.1111/ipd.12196. Epub 2015 Sep 15.

    PubMed 26370520

  • Goel N, Kumar A, Singhal R, Jha S, Namdev R, Rani R. Comparative Evaluation of Chlorhexidine Polymer Scaffold, 3Mixtatin, and Formocresol for Vital Primary Pulp Therapy: A Randomized 6-month Clinical Study. Int J Clin Pediatr Dent. 2023 May-Jun;16(3):478-482. doi: 10.5005/jp-journals-10005-2615.

    PubMed 37496952

  • Jamali Z, Alavi V, Najafpour E, Aminabadi NA, Shirazi S. Randomized Controlled Trial of Pulpotomy in Primary Molars using MTA and Formocresol Compared to 3Mixtatin: A Novel Biomaterial. J Clin Pediatr Dent. 2018;42(5):361-366. doi: 10.17796/1053-4625-42.5.7. Epub 2018 May 15.

    PubMed 29763354

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 3 mixtatin pulpotomy and MTA pulpotomy in people with Pulp Disease, Dental and Deciduous Teeth, run by Cairo University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sally A kotb, PHD researcher (00201001656502, sallyqutb9933@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical success Clinical success clinical success (time frame: 1 week , 3 months , 6 months , 9 months and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06478940, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.

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