Faculty of Dental Medicine for Girls ,Al-Azhar university
Cairo, Cairo Governorate, 11651, Egypt
NCT Number: NCT07565181
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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Notify Me16 year–45 year
All sexes
Interventional
Phase 4
Cairo, Cairo Governorate, 11651, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: Medicated ointment
A topical placebo ointment that was prepared the same as the test ointment without zinc oxide.
Other names: Ointment without Zinc Oxide
Time frame: 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
Time frame: Day before treatment,1st day,3rd day and 6th day
Measurement of erythematous halo diameter and whitish base
Time frame: 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.
Faculty of Dental Medicine for Girls
Other Gov
Evaluation of Zinc Oxide Ointment in Treatment of Recurrent Aphthous Stomatitis
Acronym: ZO-RAS
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