Lesion Sterilization And Tissue Repair Versus Zinc Oxide And Eugenol For Treatment of Necrotic Primary Molars

NCT05448937 | Completed Phase 2

• 1 other identifier: LSTR 3MIX-MP In Necrotic teeth
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the clinical and radiographic success of Lesion Sterilization And Tissue Repair \[ LSTR\] antibiotic paste versus Zinc Oxide and Eugenol pulpectomy in the treatment of non-vital primary molars.

Conditions

Necrotic Primary Molars

Outcome Measures

Primary Outcomes (12)

• Post oper3tive pain

  Measured by verbal question to patient/parents

  1 month

• Post operative pain

  Measured by verbal question to patient/parents

  3 months

• Post operative pain

  Measured by verbal question to patient/parents

  6 months

• Tenderness

  Percussion test using back of a dental mirror

  1 month

• Tenderness

  Percussion test using back of a dental mirror

  3 months

• Tenderness

  Percussion test using back of a dental mirror

  6 months

• Swelling /sinus tract or fistula

  Visual examination

  1 month

• Swelling /sinus tract or fistula

  Visual examination

  3 months

• Swelling /sinus tract or fistula

  Visual examination

  6 months

• Tooth mobility

  Mobility test

  1 month

• Tooth mobility

  Mobility test

  3 months

• Tooth mobility

  Mobility test

  6 months

Secondary Outcomes (2)

• Internal /External root resorption

  6 months

• Furcation involvement /radiolucency

  6 months

Study Arms (2)

3 MIX

EXPERIMENTAL

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).

Procedure: Lesion sterilization and tissue repair

Zinc oxide and Eugenol Pulpectomy

ACTIVE COMPARATOR

zinc oxide and eugenol (prevestdent pro™, egypt).

Procedure: zinc oxide and eugenol pulpectomy

Interventions

Lesion sterilization and tissue repair PROCEDURE

Pulp therapy for necrotic primary molars

3 MIX

zinc oxide and eugenol pulpectomy PROCEDURE

Pulp therapy for necrotic primary molars

Zinc oxide and Eugenol Pulpectomy

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children:
• Aged between 5 years and 7 years.
• With deep caries involving pulp in primary molars.
• Teeth:
• Necrotic teeth with or without periapical or furcal lesions.
• Primary molars with minimal root resorption not more than 1/3 of root.

You may not qualify if:

• Children:
• Children with systemic disease
• Previous history of allergy to antibiotics used in the study.
• Children that will not attend follow up.
• Teeth:
• Caries in primary teeth exhibiting pre-shedding mobility.
• Non restorable teeth.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of oral and dental medicine

Cairo, Egypt

Location

Related Publications (8)

• 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.

  PMID: 29073902 BACKGROUND

• 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.

  PMID: 30289365 BACKGROUND

• 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.

  PMID: 34937613 BACKGROUND

• 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.

  PMID: 27790570 BACKGROUND

• 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.

  PMID: 26059708 BACKGROUND

• 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.

  PMID: 33087217 BACKGROUND

• 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.

  PMID: 31206571 BACKGROUND

• 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.

  PMID: 29852056 BACKGROUND

MeSH Terms

Interventions

Wound Healing; Zinc Oxide

Intervention Hierarchy (Ancestors)

Regeneration; Biological Phenomena; Oxides; Oxygen Compounds; Inorganic Chemicals; Zinc Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principlal investigator

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 8, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: March 8, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)