Recurrent Aphthous Stomatitis
Conditions
Keywords
Zinc Oxide, Recurrent Aphthous Stomatitis, Treatment
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.
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.
Interventions
DRUGzinc oxide
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
DRUGPlacabo
A topical placebo ointment that was prepared the same as the test ointment without zinc oxide.
Sponsors
Faculty of Dental Medicine for Girls
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to 45 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORNaglaa M. El-Wakeel, PhD
Al Azhar University for girls
Outcome results
None listed