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Effect of Zinc Oxide Ointment on Recurrent Aphthous Stomatitis

NCT07565181 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-04

No results posted yet for this study

Summary

This randomized placebo-controlled trial evaluated the effectiveness of zinc oxide ointment in the treatment of recurrent aphthous stomatitis (RAS). The study included 100 patients randomly assigned to receive either zinc oxide ointment or a placebo, applied three times daily for six days. Pain intensity was measured using a visual analogue scale (VAS), and oral health-related quality of life was assessed using OHIP-14 at baseline and on days 1, 3, and 6.

Conditions

  • Recurrent Aphthous Stomatitis

Interventions

DRUG

zinc oxide

zinc oxide ointment that was formulated as in a polyethylene glycol base. The prepared ointment was evaluated for organoleptic properties such as odor, color, pH, smoothness, and spread ability

DRUG

Placabo

A topical placebo ointment that was prepared the same as the test ointment without zinc oxide.

Sponsors & Collaborators

  • Cairo University

    collaborator OTHER

  • Faculty of Dental Medicine for Girls

    lead OTHER_GOV

Principal Investigators

  • Naglaa M. El-Wakeel, PhD · Al Azhar University for girls

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2026-01-30
Completion
2026-03-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07565181 on ClinicalTrials.gov