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

March 18, 2026 updated by: Ahmed El-Sayed El-Metwally, Al-Azhar University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 11651
        • Recruiting
        • Al-Azhar University
        • Sub-Investigator:
          • Adel F Hussein, MD
        • Contact:
        • Sub-Investigator:
          • Salem A Salem, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Lesion sterilization and tissue repair (LSTR) using zinc oxide/ 6-gingerol mix.
Other: Zinc oxide/ 6-gingerol mix
Lesion sterilization and tissue repair (LSTR) using zinc oxide/ 6-gingerol mix.
Active Comparator: Group B
Lesion sterilization and tissue repair (LSTR) using triple antibiotic paste.
Other: Triple antibiotic paste
Lesion sterilization and tissue repair (LSTR) using triple antibiotic paste.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
6 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
One year postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

March 18, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1080/1489

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of study for one year.

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Clinical Outcomes

Clinical Trials on Zinc oxide/ 6-gingerol mix

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe