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

NCT07488416 | Recruiting

• 1 other identifier: 1080/1489
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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".

  6 months postoperatively

Secondary Outcomes (1)

• Tooth mobility

  One year postoperatively

Study Arms (2)

Group A

EXPERIMENTAL

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

Other: Zinc oxide/ 6-gingerol mix

Group B

ACTIVE COMPARATOR

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

Other: Triple antibiotic paste

Interventions

Zinc oxide/ 6-gingerol mix OTHER

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

Group A

Triple antibiotic paste OTHER

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

Group B

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar University

Cairo, 11651, Egypt

RECRUITING

MeSH Terms

Interventions

Zinc Oxide

Intervention Hierarchy (Ancestors)

Oxides; Oxygen Compounds; Inorganic Chemicals; Zinc Compounds

Central Study Contacts

Ahmed E El-Metwally, MBBCH

CONTACT

00201090888701; ahmedalsaayed647@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: B.D.S, Faculty of Dentistry (Cairo-Boys), Al-Azhar University, Cairo, Egypt.

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 23, 2026
• Study Start: October 1, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)