Effect of Zinc Oxide Ointment on Recurrent Aphthous Stomatitis

NCT07565181 | Completed Phase 4

• 1 other identifier: OMDR_105_1q
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Zinc Oxide; Recurrent Aphthous Stomatitis; Treatment

Outcome Measures

Primary Outcomes (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

  Before treatment ,Day 1,Day 3 and Day 6

Secondary Outcomes (2)

• Diameter of the ulcer

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

• OHIP-14

  At day 6

Study Arms (2)

Znic Oxide Ointment group

EXPERIMENTAL

Participants administrated Zinc Oxide Ointment 3 times for 7days. Participants instructed to apply ointment after drinking and eating.

Drug: zinc oxide

Placebo

PLACEBO COMPARATOR

Placebo ointment was administered by this group; it was prepared the same as the test ointment, without zinc oxide.

Drug: Placabo

Interventions

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

Also known as: Medicated ointment

Znic Oxide Ointment group

Placabo DRUG

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

Also known as: Ointment without Zinc Oxide

Placebo

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Faculty of Dental Medicine for Girls: lead
• Cairo University: collaborator

Study Sites (1)

Faculty of Dental Medicine for Girls ,Al-Azhar university

Cairo, Cairo Governorate, 11651, Egypt

Location

Related Publications (8)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Stomatitis, Aphthous

Interventions

Zinc Oxide; Ointments

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oxides; Oxygen Compounds; Inorganic Chemicals; Zinc Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Naglaa M. El-Wakeel, PhD

  Al Azhar University for girls

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dental student

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 4, 2026
• Study Start: June 30, 2025
• Primary Completion: January 30, 2026
• Study Completion: March 30, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)