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Recurrent Aphthous StomatitisPhase 4ZO-RASNCT07565181

Effect of Zinc Oxide Ointment on Recurrent Aphthous Stomatitis

A Phase 4 study testing zinc oxide and Placabo in people with Recurrent Aphthous Stomatitis, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 45 years
Conditions the study is for
Recurrent Aphthous Stomatitis
What is being tested?
zinc oxide and Placabo
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteEgypt
Study dates
30 Jun 2025to 30 Mar 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 45 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • -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.

Who cannot join

  • -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).

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Faculty of Dental Medicine for Girls ,Al-Azhar university

    Cairo, Cairo Governorate, 11651

Other trials in Egypt

About this study

Official title: Evaluation of Zinc Oxide Ointment in Treatment of 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.

Read the 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.

Being tested
zinc oxide, Placabo
Keywords
Zinc Oxide, Recurrent Aphthous Stomatitis, Treatment
Medical subject headings
Stomatitis, Aphthous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • zinc oxideDrug

    Also called 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

  • PlacaboDrug

    Also called Ointment without Zinc Oxide

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

Study groups in NCT07565181
Study groupRoleWhat they receive
Znic Oxide Ointment groupExperimentalParticipants administrated Zinc Oxide Ointment 3 times for 7days. Participants instructed to apply ointment after drinking and eating.
Receives: Drug: zinc oxide
PlaceboPlacebo comparatorPlacebo ointment was administered by this group; it was prepared the same as the test ointment, without zinc oxide.
Receives: Drug: Placabo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Before treatment ,Day 1,Day 3 and Day 6

Secondary outcomes (2)

  1. Diameter of the ulcer

    Measurement of erythematous halo diameter and whitish base

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

  2. 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.

    Measured: At day 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2026
  2. Study start30 Jun 2025
  3. Primary completion30 Jan 2026
  4. Study completion30 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07565181
Sponsor's protocol ID
OMDR_105_1q
Acronym
ZO-RAS
Status last verified
Apr 2026
First submitted
22 Apr 2026
Last updated
4 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 33234003

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing zinc oxide and Placabo in people with Recurrent Aphthous Stomatitis, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual analog scale (time frame: Before treatment ,Day 1,Day 3 and Day 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07565181, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.

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