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Recruiting NCT07488416

Clinical and Radiographic Outcomes of Lesion Sterilization and Tissue Repair Using Zinc Oxide/ 6-gingerol Mix Versus Triple Antibiotic Paste in Non-vital Primary Molars

No phase Interventional Clinical Outcomes Radiographic Outcomes Lesion Sterilization Tissue Repair

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Zinc oxide/ 6-gingerol mix, Triple antibiotic paste.
Who it may be relevant to
Registry conditions: Clinical Outcomes, Radiographic Outcomes, Lesion Sterilization, Tissue Repair. Basic parameters: 4 years — 8 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparative Evaluation of Clinical and Radiographic Outcomes of Lesion Sterilization and Tissue Repair Using Zinc Oxide/ 6-gingerol Mix Versus Triple Antibiotic Paste in Non-vital Primary Molars: A Randomized Clinical Trial

Overview

This study aims to evaluate and compare the clinical and radiographic outcomes of Lesion sterilization and tissue repair using zinc oxide/ 6-gingerol mix versus triple antibiotic paste in non-vital primary molars.

Detailed description

In routine dental practice, clinicians often face challenges when primary teeth are affected by dental caries and periapical changes, which may exceed the limits of conventional endodontic treatments. Extraction often becomes the only viable option due to factors like extensive root resorption, poor bone support, and uncooperative young patients.

One promising less invasive method is Lesion Sterilization and Tissue Repair (LSTR), developed by Niigata University. This approach uses minimal instrumentation and applies an antibiotic mixture to disinfect the root canal and periapical lesions, often using a "three mix MP paste" of metronidazole, ciprofloxacin, and minocycline. Recently, clindamycin has been used instead of minocycline to avoid tooth discoloration.

Interventions

  • Other Zinc oxide/ 6-gingerol mix
    Lesion sterilization and tissue repair (LSTR) using zinc oxide/ 6-gingerol mix.
  • Other Triple antibiotic paste
    Lesion sterilization and tissue repair (LSTR) using triple antibiotic paste.

Primary outcome measures

  • Assessment of pain [Time frame: 6 months postoperatively]
Secondary outcome measures (1)
  • Tooth mobility [Time frame: One year postoperatively]

Eligibility criteria

Inclusion criteria

  • Age from 4 to 8 years.
  • Both sexes
  • Children must have at least two restorable non-vital primary molars
  • Periapical radiolucency.
  • Pain on mastication.
  • Pathological mobility.
  • Internal or external root resorption.
  • Furcation involvement should not extend to the developing tooth germ.

Exclusion criteria

  • Presence of systemic diseases.
  • Teeth with physiological mobility near exfoliation time.
  • Teeth with vital pulp.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Al-Azhar University — Cairo

Identifiers

NCT: NCT07488416 · 1080/1489

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗