Lesion Sterilization And Tissue Repair Versus Zinc Oxide And Eugenol For Treatment of Necrotic Primary Molars
NCT ID: NCT05448937
Last Updated: 2025-08-03
Study Results
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Basic Information
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COMPLETED
PHASE2/PHASE3
60 participants
INTERVENTIONAL
2022-10-01
2025-03-08
Brief Summary
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Detailed Description
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Among the pastes used in the pulp therapy of primary teeth with pulp necrosis, zinc oxide and eugenol paste has been a reference in dentistry since 1930. Endodontic treatment using zinc oxide and eugenol paste has shown satisfactory clinical and radiographic results, requires mechanical chemical preparation before filling root canals.
The main difficulties of endodontic treatment of primary molars are related to the anatomical complexity of the root canals and the long time needed to carry out the treatment. The additional difficulty involved in diagnosing root resorption is a limiting condition for determining the actual working length and instrumentation.
Other pastes have been studied, such as those containing antibiotics in their composition, thus dispensing with root canal instrumentation (such as lesion sterilization and tissue repair using triple antibiotic paste in treatment of non-vital primary molars.
Lesion sterilization and tissue repair using triple antibiotic paste has relevant clinical and radiographic success rates in treatment of non-vital primary molars.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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3 MIX
Lesion sterilization and tissue repair; preparation of modified triple antibiotic paste tap: the chemotherapeutic agents used are metronidazole tablets 500 mg (flagyl®, sanofi, egypt), ciprofloxacin tablets 500 mg (ciproxcin®,. Epico, egypt,), and doxycycline capsules 100 mg (doxymycin™ dt, el-nile pharmaceuticals, egypt).
Lesion sterilization and tissue repair
Pulp therapy for necrotic primary molars
Zinc oxide and Eugenol Pulpectomy
zinc oxide and eugenol (prevestdent pro™, egypt).
zinc oxide and eugenol pulpectomy
Pulp therapy for necrotic primary molars
Interventions
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Lesion sterilization and tissue repair
Pulp therapy for necrotic primary molars
zinc oxide and eugenol pulpectomy
Pulp therapy for necrotic primary molars
Eligibility Criteria
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Inclusion Criteria
1. Aged between 5 years and 7 years.
2. With deep caries involving pulp in primary molars.
* Teeth:
1. Necrotic teeth with or without periapical or furcal lesions.
2. Primary molars with minimal root resorption not more than 1/3 of root.
Exclusion Criteria
1. Children with systemic disease
2. Previous history of allergy to antibiotics used in the study.
3. Children that will not attend follow up.
* Teeth:
1. Caries in primary teeth exhibiting pre-shedding mobility.
2. Non restorable teeth.
5 Years
7 Years
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Esraa Mohamed Ahmed Abdeltawab
principlal investigator
Locations
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Faculty of oral and dental medicine
Cairo, , Egypt
Countries
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References
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Chen X, Liu X, Zhong J. Clinical and radiographic evaluation of pulpectomy in primary teeth: a 18-months clinical randomized controlled trial. Head Face Med. 2017 Oct 27;13(1):12. doi: 10.1186/s13005-017-0145-1.
Luengo-Fereira J, Ayala-Jimenez S, Carlos-Medrano LE, Toscano-Garcia I, Anaya-Alvarez M. Clinical and Radiographic Evaluation of Formocresol and Chloramphenicol, Tetracycline and Zinc Oxide-Eugenol Antibiotic Paste in Primary Teeth Pulpotomies: 24 month follow up. J Clin Pediatr Dent. 2019;43(1):16-21. doi: 10.17796/1053-4625-43.1.4. Epub 2018 Oct 5.
Moura J, Lima M, Nogueira N, Castro M, Lima C, Moura M, Moura L. LSTR Antibiotic Paste Versus Zinc Oxide and Eugenol Pulpectomy for the Treatment of Primary Molars with Pulp Necrosis: A Randomized Controlled Trial. Pediatr Dent. 2021 Nov 15;43(6):435-442.
Navit S, Jaiswal N, Khan SA, Malhotra S, Sharma A, Mukesh, Jabeen S, Agarwal G. Antimicrobial Efficacy of Contemporary Obturating Materials used in Primary Teeth- An In-vitro Study. J Clin Diagn Res. 2016 Sep;10(9):ZC09-ZC12. doi: 10.7860/JCDR/2016/21883.8426. Epub 2016 Sep 1.
Pramila R, Muthu MS, Deepa G, Farzan JM, Rodrigues SJ. Pulpectomies in primary mandibular molars: a comparison of outcomes using three root filling materials. Int Endod J. 2016 May;49(5):413-21. doi: 10.1111/iej.12478. Epub 2015 Jul 4.
Coll JA, Dhar V, Vargas K, Chen CY, Crystal YO, AlShamali S, Marghalani AA. Use of Non-Vital Pulp Therapies in Primary Teeth. Pediatr Dent. 2020 Sep 15;42(5):337-349.
Zacharczuk GA, Toscano MA, Lopez GE, Ortolani AM. Evaluation of 3Mix-MP and pulpectomies in non-vital primary molars. Acta Odontol Latinoam. 2019 Apr 1;32(1):22-28.
Smail-Faugeron V, Glenny AM, Courson F, Durieux P, Muller-Bolla M, Fron Chabouis H. Pulp treatment for extensive decay in primary teeth. Cochrane Database Syst Rev. 2018 May 31;5(5):CD003220. doi: 10.1002/14651858.CD003220.pub3.
Other Identifiers
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LSTR 3MIX-MP In Necrotic teeth
Identifier Type: -
Identifier Source: org_study_id
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