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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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07488416
Enrollment
60
Registered
2026-03-23
Start date
2024-10-01
Completion date
2026-05-01
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical Outcomes, Radiographic Outcomes, Lesion Sterilization, Tissue Repair, Zinc Oxide, 6-gingerol, Triple Antibiotic Paste, Non-vital, Primary Molars

Brief summary

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

OTHERZinc oxide/ 6-gingerol mix

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

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

Sponsors

Al-Azhar University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Assessment of pain6 months postoperativelyPain 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

MeasureTime frameDescription
Tooth mobilityOne year postoperativelyTooth 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).

Countries

Egypt

Contacts

CONTACTAhmed E El-Metwally, MBBCH
ahmedalsaayed647@gmail.com00201090888701

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026