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

Cairo University (CU) logo

Cairo University (CU)

Status and phase

Not yet enrolling
Phase 4

Conditions

Necrotic Primary Molars

Treatments

Procedure: Lesion sterilization and tissue repair
Procedure: zinc oxide and eugenol pulpectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT05448937
LSTR 3MIX-MP In Necrotic teeth

Details and patient eligibility

About

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.

Full description

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.

Enrollment

60 estimated patients

Sex

All

Ages

5 to 7 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

3 MIX
Experimental group
Description:
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).
Treatment:
Procedure: Lesion sterilization and tissue repair
Zinc oxide and Eugenol Pulpectomy
Active Comparator group
Description:
zinc oxide and eugenol (prevestdent pro™, egypt).
Treatment:
Procedure: zinc oxide and eugenol pulpectomy

Trial contacts and locations

0

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Central trial contact

Esraa Mohamed Abdeltawab, B.D.S; Shereen Hassan El shamy, Lecturer

Data sourced from clinicaltrials.gov

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