3Mixtatin and MTA Vital Pulpotomy in Primary Molars

NCT06478940 | Not Yet Recruiting Phase 1

• 1 other identifier: 3Mixtatin and MTA pulpotomy
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulp Disease, Dental; Deciduous Teeth

Keywords

pulpotomy - vital pulp therapy; primary molars- baby teeth

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (1)

• Radiographic success radiographic success

  3 months , 6 months , 12 months

Study Arms (2)

MTA pulpotomy

ACTIVE COMPARATOR

pulpotomy with MTA applied in the vital pulp therapy

Drug: MTA pulpotomy

3 Mixtatin pulpotomy

EXPERIMENTAL

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

Interventions

3 mixtatin pulpotomy DRUG

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

3 Mixtatin pulpotomy

MTA pulpotomy DRUG

pulp treatment with applying MTA

MTA pulpotomy

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (8)

• 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.

  PMID: 38433296 BACKGROUND

• 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.

  PMID: 38448571 BACKGROUND

• 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.

  PMID: 38344366 BACKGROUND

• 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.

  PMID: 35645497 BACKGROUND

• 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.

  PMID: 26950808 BACKGROUND

• 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.

  PMID: 26370520 BACKGROUND

• 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.

  PMID: 37496952 BACKGROUND

• 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.

  PMID: 29763354 BACKGROUND

MeSH Terms

Conditions

Dental Pulp Diseases

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Randa y Abd Al Gawad, professor

  Professor of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University

  STUDY DIRECTOR

• Yasmin M Yousry, Associate professor

  Assistant Professor of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University

  STUDY CHAIR

Central Study Contacts

Sally A kotb, PHD researcher

CONTACT

00201001656502; sallyqutb9933@gmail.com

Eslam M Mahdy

CONTACT

00201143683135; eslam.mahdy@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: June 23, 2024
• First Posted: June 27, 2024
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: June 27, 2024

Record last verified: 2024-06