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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2025-03-08

Brief Summary

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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.

Detailed Description

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Primary teeth with infected root canals are a common problem, particularly in patients where the infection has reached the peri radicular tissues .

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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Necrotic Primary Molars

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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).

Group Type EXPERIMENTAL

Lesion sterilization and tissue repair

Intervention Type PROCEDURE

Pulp therapy for necrotic primary molars

Zinc oxide and Eugenol Pulpectomy

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

Group Type ACTIVE_COMPARATOR

zinc oxide and eugenol pulpectomy

Intervention Type PROCEDURE

Pulp therapy for necrotic primary molars

Interventions

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Lesion sterilization and tissue repair

Pulp therapy for necrotic primary molars

Intervention Type PROCEDURE

zinc oxide and eugenol pulpectomy

Pulp therapy for necrotic primary molars

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Children:

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

* Children:

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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Esraa Mohamed Ahmed Abdeltawab

principlal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of oral and dental medicine

Cairo, , Egypt

Site Status

Countries

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Egypt

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.

Reference Type BACKGROUND
PMID: 29073902 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30289365 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34937613 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27790570 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26059708 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33087217 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31206571 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29852056 (View on PubMed)

Other Identifiers

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LSTR 3MIX-MP In Necrotic teeth

Identifier Type: -

Identifier Source: org_study_id

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