Effect of Zinc Oxide Ointment on Recurrent Aphthous Stomatitis (ZO-RAS)
29. april 2026 oppdatert av: Esraa hamdy, Faculty of Dental Medicine for Girls
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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
100
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egypt, 11651
- Faculty of Dental Medicine for Girls ,Al-Azhar university
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
Tar imot friske frivillige
Nei
Beskrivelse
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).
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Znic Oxide Ointment group
Participants administrated Zinc Oxide Ointment 3 times for 7days.
Participants instructed to apply ointment after drinking and eating.
|
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
Andre navn:
|
|
Placebo komparator: Placebo
Placebo ointment was administered by this group; it was prepared the same as the test ointment, without zinc oxide.
|
A topical placebo ointment that was prepared the same as the test ointment without zinc oxide.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Visual analog scale
Tidsramme: 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
|
Before treatment ,Day 1,Day 3 and Day 6
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Diameter of the ulcer
Tidsramme: Day before treatment,1st day,3rd day and 6th day
|
Measurement of erythematous halo diameter and whitish base
|
Day before treatment,1st day,3rd day and 6th day
|
|
OHIP-14
Tidsramme: 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.
|
At day 6
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Naglaa M. El-Wakeel, PhD, Al Azhar University for girls
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
30. juni 2025
Primær fullføring (Faktiske)
30. januar 2026
Studiet fullført (Faktiske)
30. mars 2026
Datoer for studieregistrering
Først innsendt
22. april 2026
Først innsendt som oppfylte QC-kriteriene
29. april 2026
Først lagt ut (Faktiske)
4. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. april 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- OMDR_105_1q
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .