Study Results
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Basic Information
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NOT_YET_RECRUITING
PHASE1
50 participants
INTERVENTIONAL
2024-08-01
2025-09-01
Brief Summary
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Detailed Description
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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 .
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MTA pulpotomy
pulpotomy with MTA applied in the vital pulp therapy
MTA pulpotomy
pulp treatment with applying MTA
3 Mixtatin pulpotomy
pulpotomy with 3 mixtatin (triple antibiotic paste of (Metronidazole, cefixime, and Ciprofloxacin mixed with simvastatin ) applied in the vital pulp therapy
3 mixtatin pulpotomy
pulp treatment with applying 3mixture of antibiotic (Metronidazole, cefixime, and Ciprofloxacin) along with simvastatin
Interventions
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3 mixtatin pulpotomy
pulp treatment with applying 3mixture of antibiotic (Metronidazole, cefixime, and Ciprofloxacin) along with simvastatin
MTA pulpotomy
pulp treatment with applying MTA
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
4 Years
8 Years
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Sally Ahmed Kotb
doctor
Principal Investigators
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Randa y Abd Al Gawad, professor
Role: STUDY_DIRECTOR
Professor of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University
Yasmin M Yousry, Associate professor
Role: STUDY_CHAIR
Assistant Professor of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University
Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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3Mixtatin and MTA pulpotomy
Identifier Type: -
Identifier Source: org_study_id
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