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Completed

NCT Number: NCT07565181

Effect of Zinc Oxide Ointment on Recurrent Aphthous Stomatitis

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.

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Key information

Age range

16 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Dental Medicine for Girls ,Al-Azhar university

Cairo, Cairo Governorate, 11651, Egypt

About this study

This randomized, placebo-controlled clinical trial investigated the efficacy of topical zinc oxide ointment in the management of recurrent aphthous stomatitis (RAS). A total of 100 participants diagnosed with RAS were enrolled and randomly assigned in equal proportions to either the intervention group receiving zinc oxide ointment or the control group receiving a placebo formulation. The study medication was applied topically three times daily for a duration of six consecutive days.

Clinical outcomes were assessed at baseline and on days 1, 3, and 6 post-treatment initiation. Pain intensity was evaluated using a visual analogue scale (VAS), while oral health-related quality of life was measured using the Oral Health Impact Profile (OHIP-14). Additional clinical observation included assessment of ulcer size and surrounding erythematous halo.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • -Systemically healthy subjects suffering from minor oral RAS.
  • Patients of both sexes, aged 16-45 years (to avoid the potential effects of age on healing).
  • Participants had not received any treatment for the ulcers before being included in the study and had no active periodontitis.
  • Ulcers are of a duration of less than 48 hours.

Exclusion criteria

  • -Participants with removable prosthetic or orthodontic appliances (to avoid potential effects on healing).
  • Tobacco chewers, smokers or alcoholics.
  • Pregnant or lactating females.
  • Patients who had previously or are presently taking medications that could affect events associated with the healing process (erg, corticosteroids, oral antidiabetics, non-steroidal anti-inflammatory drugs, immune-modulating agents).

Treatment and study plan

zinc oxide

Drug

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

Other names: Medicated ointment

Placabo

Drug

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

Other names: Ointment without Zinc Oxide

Primary outcomes

  1. Visual analog scale

    Time frame: Before treatment ,Day 1,Day 3 and Day 6

    A Visual Analog Scale (VAS) is a subjective, validated, 100mm (or 10cm) straight-line tool used in healthcare to measure pain intensity, fatigue, or other sensations. Patients mark their sensation level between "no pain" (0) and "worst pain imaginable" (100). It is highly sensitive for tracking changes in symptoms over time

Secondary outcomes

  1. Diameter of the ulcer

    Time frame: Day before treatment,1st day,3rd day and 6th day

    Measurement of erythematous halo diameter and whitish base

  2. OHIP-14

    Time frame: At day 6

    Oral health impact 14 questionnaire Secondary outcome: Oral health-related quality of life assessed using the validated Oral Health Impact Profile-14 (OHIP-14), with scores ranging from 0 to 56, where higher scores indicate poorer quality of life.

Sponsors and collaborators

Lead sponsor

Faculty of Dental Medicine for Girls

Other Gov

Collaborators

  • Cairo University

Registry information

Official study title

Evaluation of Zinc Oxide Ointment in Treatment of Recurrent Aphthous Stomatitis

Acronym: ZO-RAS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 4, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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