Clinical OutcomesNCT07488416
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 study testing Zinc oxide/ 6-gingerol mix and Triple antibiotic paste in people with Clinical Outcomes and Radiographic Outcomes, run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Clinical Outcomes, Radiographic Outcomes, Lesion Sterilization
- What is being tested?
- Zinc oxide/ 6-gingerol mix and Triple antibiotic paste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Presence of systemic diseases.
- Teeth with physiological mobility near exfoliation time.
- Teeth with vital pulp.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Al-Azhar University
Cairo, 11651
Ahmed E El-Metwally, MBBCH, 00201090888701, ahmedalsaayed647@gmail.com
Adel F Hussein, MD
About this study
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
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.
Read the 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.
- Conditions
- Clinical Outcomes, Radiographic Outcomes, Lesion Sterilization, Tissue Repair, Zinc Oxide, 6-gingerol
- Being tested
- Zinc oxide/ 6-gingerol mix, Triple antibiotic paste
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc oxide/ 6-gingerol mixOther
Lesion sterilization and tissue repair (LSTR) using zinc oxide/ 6-gingerol mix.
Triple antibiotic pasteOther
Lesion sterilization and tissue repair (LSTR) using triple antibiotic paste.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Lesion sterilization and tissue repair (LSTR) using zinc oxide/ 6-gingerol mix. Receives: Other: Zinc oxide/ 6-gingerol mix |
| Group B | Active comparator | Lesion sterilization and tissue repair (LSTR) using triple antibiotic paste. Receives: Other: Triple antibiotic paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pain
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".
Measured: 6 months postoperatively
Secondary outcomes (1)
Tooth mobility
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).
Measured: One year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start1 Oct 2024
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical OutcomesStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed El-Sayed El-Metwally, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488416
- Sponsor's protocol ID
- 1080/1489
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07488416
- Acronym / sponsor ID
- 1080/1489
- Conditions
- Clinical Outcomes, Radiographic Outcomes, Lesion Sterilization, Tissue Repair, Zinc Oxide, 6-gingerol
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Zinc oxide/ 6-gingerol mixLesion sterilization and tissue repair (LSTR) using zinc oxide/ 6-gingerol mix. |
| Group B | Active comparator | Other: Triple antibiotic pasteLesion sterilization and tissue repair (LSTR) using triple antibiotic paste. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age from 4 to 8 years.
- Both sexes
- Children must have at least two restorable non-vital primary molars
- Periapical radiolucency.
- Pain on mastication.
Key exclusion criteria (3 listed)
- Presence of systemic diseases.
- Teeth with physiological mobility near exfoliation time.
- Teeth with vital pulp.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc oxide/ 6-gingerol mixLesion sterilization and tissue repair (LSTR) using zinc oxide/ 6-gingerol mix. | Other | Group A |
| Triple antibiotic pasteLesion sterilization and tissue repair (LSTR) using triple antibiotic paste. | Other | Group B |
Primary outcome
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".
1 secondary outcome
Tooth mobility
Time frame: One year postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zinc oxide/ 6-gingerol mix and Triple antibiotic paste in people with Clinical Outcomes and Radiographic Outcomes, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed E El-Metwally, MBBCH (00201090888701, ahmedalsaayed647@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pain (time frame: 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.