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NCT Number: 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

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.

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Key information

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Azhar University

Cairo, 11651, Egypt

Location status: Recruiting

Location contact

Adel F Hussein, MD

SUB_INVESTIGATOR

Ahmed E El-Metwally, MBBCH

CONTACT

[email protected]

00201090888701

Salem A Salem, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Zinc oxide/ 6-gingerol mix

Other

Lesion sterilization and tissue repair (LSTR) using zinc oxide/ 6-gingerol mix.

Triple antibiotic paste

Other

Lesion sterilization and tissue repair (LSTR) using triple antibiotic paste.

Primary outcomes

  1. Assessment of pain

    Time frame: 6 months postoperatively

    Pain will be assessed using age-appropriate pain scales (5-point Likert scale for children) with 0 typically representing "no pain" and 4 representing "very high/extreme pain".

Secondary outcomes

  1. Tooth mobility

    Time frame: One year postoperatively

    Tooth mobility is the horizontal or vertical looseness of a tooth beyond its normal physiological range. It is graded from 0 (no mobility) to 3 (severe, >2mm or vertical movement).

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed E El-Metwally, MBBCH

CONTACT

[email protected]

00201090888701

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 23, 2026
Registry last updated
Mar 23, 2026

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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