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Completed

NCT Number: NCT05448937

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

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.

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Key information

Age range

5 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Faculty of oral and dental medicine

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Lesion sterilization and tissue repair

Procedure

Pulp therapy for necrotic primary molars

zinc oxide and eugenol pulpectomy

Procedure

Pulp therapy for necrotic primary molars

Primary outcomes

  1. Post oper3tive pain

    Time frame: 1 month

    Measured by verbal question to patient/parents

  2. Post operative pain

    Time frame: 3 months

    Measured by verbal question to patient/parents

  3. Post operative pain

    Time frame: 6 months

    Measured by verbal question to patient/parents

  4. Tenderness

    Time frame: 1 month

    Percussion test using back of a dental mirror

  5. Tenderness

    Time frame: 3 months

    Percussion test using back of a dental mirror

  6. Tenderness

    Time frame: 6 months

    Percussion test using back of a dental mirror

  7. Swelling /sinus tract or fistula

    Time frame: 1 month

    Visual examination

  8. Swelling /sinus tract or fistula

    Time frame: 3 months

    Visual examination

  9. Swelling /sinus tract or fistula

    Time frame: 6 months

    Visual examination

  10. Tooth mobility

    Time frame: 1 month

    Mobility test

  11. Tooth mobility

    Time frame: 3 months

    Mobility test

  12. Tooth mobility

    Time frame: 6 months

    Mobility test

Secondary outcomes

  1. Internal /External root resorption

    Time frame: 6 months

    Radiographic examination

  2. Furcation involvement /radiolucency

    Time frame: 6 months

    Radiographic examination

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical And Radiographic Evaluation Of Lesion Sterilization And Tissue Repair Versus Zinc Oxide And Eugenol For Treatment of Necrotic Primary Molars

Acronym: LSTR

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Jul 8, 2022
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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