Evaluation of Zinc Oxide Ointment in Treatment of Recurrent Aphthous Stomatitis
| Registry | NCT07565181, acronym ZO-RAS |
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| Status | Completed |
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| Phase | Phase 4 |
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| Study type | Interventional; randomized, parallel, masking: double, treatment |
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| Enrollment | 100 (Actual) |
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| Sponsor | Faculty of Dental Medicine for Girls (Other gov); collaborators: Cairo University |
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| Conditions | Recurrent Aphthous Stomatitis |
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| Interventions | zinc oxide, Placabo (Drug) |
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| Dates | start 2025-06-30, primary completion 2026-01-30, completion 2026-03-30, first posted 2026-05-04, last updated 2026-05-04 |
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| Locations | 1 site in Egypt |
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Related Papers Related Patents Related Grants Related Experts
All trials for Recurrent Aphthous Stomatitis All trials of zinc oxide All trials of Placabo
-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.
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+Detailed description
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.
+Arms and interventions
| Arm | Type | Interventions | Description |
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| Znic Oxide Ointment group | Experimental | Drug: zinc oxide | Participants administrated Zinc Oxide Ointment 3 times for 7days. Participants instructed to apply ointment after drinking and eating. |
| Placebo | Placebo comparator | Drug: Placabo | Placebo ointment was administered by this group; it was prepared the same as the test ointment, without zinc oxide. |
- zinc oxide (Drug), also known as Medicated ointment: 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
- Placabo (Drug), also known as Ointment without Zinc Oxide: A topical placebo ointment that was prepared the same as the test ointment without zinc oxide.
+Outcome measures
Primary outcomes
- Visual analog scale [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
- Diameter of the ulcer [Day before treatment,1st day,3rd day and 6th day]: Measurement of erythematous halo diameter and whitish base
- OHIP-14 [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.
+Eligibility
Sex: All, ages: 16 Years to 45 Years
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).
+Locations (1)
| Facility | City | Country | Status |
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| Faculty of Dental Medicine for Girls ,Al-Azhar university | Cairo, Cairo Governorate | Egypt | |
+Publications
- El-Wakeel NM, Dawoud MHS. Topical insulin-liposomal formulation in management of recurrent aphthous ulcers: A randomized placebo-controlled trial. J Investig Clin Dent. 2019 Nov;10(4):e12437. doi: 10.1111/jicd.12437. Epub 2019 Jul 27. PMID 31350870
- Ghorbani A, Akbari J, Boorboor M, Nekoukar Z, Eslami G. Evaluation of zinc sulfate mucoadhesive formulation on recurrent aphthous stomatitis: a randomized double-blind, placebo-controlled clinical trial. BMC Oral Health. 2020 Jul 28;20(1):212. doi: 10.1186/s12903-020-01194-4. PMID 32723352
- Halboub E, Al-Maweri SA, Parveen S, Al-Wesabi M, Al-Sharani HM, Al-Sharani A, Al-Kamel A, Albashari A, Shamala A. Zinc supplementation for prevention and management of recurrent aphthous stomatitis: a systematic review. J Trace Elem Med Biol. 2021 Dec;68:126811. doi: 10.1016/j.jtemb.2021.126811. Epub 2021 Jun 12. PMID 34146924
- Estornut C, Rinaldi G, Carceller MC, Estornut S, Perez-Leal M. Systemic and local effect of oxidative stress on recurrent aphthous stomatitis: systematic review. J Mol Med (Berl). 2024 Apr;102(4):453-463. doi: 10.1007/s00109-024-02434-8. Epub 2024 Feb 20. PMID 38376817
- Parssinen M, Jasberg H, Mikkonen JJW, Kullaa AM. Oral mucosal pellicle as an immune protection against micro-organisms in patients with recurrent aphthous stomatitis: A hypothesis. Med Hypotheses. 2021 Jan;146:110449. doi: 10.1016/j.mehy.2020.110449. Epub 2020 Dec 11. PMID 33359920
- Al-Maweri SA, Halboub E, Al-Sharani HM, Shamala A, Al-Kamel A, Al-Wesabi M, Albashari A, Al-Sharani A, Abdulrab S. Association between serum zinc levels and recurrent aphthous stomatitis: a meta-analysis with trial sequential analysis. Clin Oral Investig. 2021 Feb;25(2):407-415. doi: 10.1007/s00784-020-03704-8. Epub 2021 Jan 6. PMID 33409687
- Kounoupis V, Andreadis D, Georgaki M, Albanidou-Farmaki E, Daniilidis M, Markopoulos A, Karyotis N, Nikitakis NG, Poulopoulos A. IL-10 and TGF-beta1 gene polymorphisms in Greek patients with recurrent aphthous stomatitis. Med Oral Patol Oral Cir Bucal. 2022 Sep 1;27(5):e426-e433. doi: 10.4317/medoral.25352. PMID 35660731
- Silva TM, Bolzan TCA, Zanini MS, Alencar T, Rodrigues WD, Bastos KA, Severi JA, Resende JA, Villanova JCO. Development and Evaluation of a Novel Oral Mucoadhesive Ointment Containing Pomegranate Peel Extract as an Adjuvant for Oral Hygiene of Dogs. J Vet Dent. 2020 Sep;37(3):133-140. doi: 10.1177/0898756420973470. Epub 2020 Nov 25. PMID 33234003
+Investigators