A Phase 4 interventional study of zinc oxide and Placabo in Recurrent Aphthous Stomatitis, sponsored by Faculty of Dental Medicine for Girls. Completed at 1 site in Egypt. Open to participants aged 16 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by Faculty of Dental Medicine for Girls · Phase 4, Interventional, and Treatment
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.
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.
63 studies on the registry are indexed under Stomatitis, Aphthous; 17 are open to participants now.
This study's enrollment of 100 is above the median of 41 across 54 interventional studies indexed under Stomatitis, Aphthous.
Browse Stomatitis, Aphthous studies →Faculty of Dental Medicine for Girls is the lead sponsor of 54 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants administrated Zinc Oxide Ointment 3 times for 7days. Participants instructed to apply ointment after drinking and eating.
Drug: zinc oxide
Placebo ointment was administered by this group; it was prepared the same as the test ointment, without zinc oxide.
Drug: Placabo
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
Also known as: Medicated ointment
A topical placebo ointment that was prepared the same as the test ointment without zinc oxide.
Also known as: Ointment without Zinc Oxide
Visual analog scale
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
Time frame: Before treatment ,Day 1,Day 3 and Day 6
Diameter of the ulcer
Measurement of erythematous halo diameter and whitish base
Time frame: Day before treatment,1st day,3rd day and 6th day
OHIP-14
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.
Time frame: At day 6
Plan to share: No — This study investigated whether zinc oxide (ZnO) ointment can help reduce pain and improve healing in patients with recurrent aphthous ulcers (mouth ulcers). One hundred participants were divided into two groups: one received ZnO ointment and the other received a placebo. The treatment was applied three times daily for six days. Pain levels and oral health impact were measured before and after treatment. The results showed that ZnO ointment helped reduce pain faster in the early days compared to placebo, but there was no significant difference in overall quality of life after six days.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Zinc Oxide
Faculty of Dental Medicine for Girls