[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522592":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":39,"studyPopulation":25,"armGroups":40,"interventions":53,"overallOfficials":25,"centralContacts":65,"locations":75,"responsibleParty":91,"collaborators":25,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":25,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":25,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":78,"whyStopped":25,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Cairo University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"Pain intensity associated with oral aphthous ulcers","pain from oral ulcers will be assessed through visual analogue scale","During the first week (days 0, 3,5 and 7)",[14,17,21],{"measure":15,"description":16,"timeFrame":12},"Number of oral ulcers","Number of oral ulcers will be determined through clinical examination",{"measure":18,"description":19,"timeFrame":20},"healing time of oral ulcers","healing time of oral ulcers will be determined through clinical examination","During the first week (days 0, 3,5, and 7)",{"measure":22,"description":23,"timeFrame":24},"Diameter of oral ulcers","Diameter of oral ulcers will be determined through clinical examination","During the first week (days 0, 3,5 and 7),",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":29,"primaryPurpose":30,"observationalModel":25,"timePerspective":25,"maskingInfo":31},"RANDOMIZED","PARALLEL","The study is a parallel 2 arm randomized controlled clinical trial where one group will be assigned to the rebamipide mouthwash, while the other group will be assigned to the betamethasone group randomly.","TREATMENT",{"masking":32,"maskingDescription":33,"whoMasked":34},"QUADRUPLE","the allocation of the participants to the groups will be concealed . The bottles of both mouthwashes will be the same. The solution of both mouthwashes will be of the same colour, odor and consistency.",[35,36,37,38],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","This is a Randomized clinical trial (RCT) parallel groups, two arm, equivalence framework with 1:1 allocation ratio which is based on the hypothesis that topical rebamipide has comparable effect to topical betamethasone on pain intensity in patients having recurrent oral aphthous ulcers.\n\nThe participants will be recruited from the pool of the Clinics Medicine, Periodontology and Diagnostic centre, Faculty of Dentistry - Cairo University. The eligible participants will be enrolled in the study in a consecutive order till the sample size is achieved.\n\nSimple randomization will be generated using computerized random number generator (random.org) with allocation ratio (1:1).\n\nAllocation concealment will be done using sequentially numbered sealed opaque containers of the same shape, size and colour until interventions are assigned.\n\nThe entire procedure will be explained to the patients and a written consent will be obtained by the operator.\n\nParticipants and care givers will be blinded as both topical rebamipide and topical betamethasone mouthwashes will be of same consistency and will be provided in sealed opaque containers of the same shape, size and colour.\n\nThe enrolled patients will be divided randomly into two groups. One group will receive topical rebamipide mouthwash four times daily for one week or till healing and the other group will receive topical Corticosteroid (topical betamethasone) four times daily for one week or till healing. The patients will be recalled in the first week (days 3, 5 and 7). The patients will be asked to prohibit use of any topical medication during the trial. Outcome measures will be recorded in each visit.\n\nData will be analyzed using IBM SPSS advanced statistics (Statistical Package for Social Sciences), version 24 (SPSS Inc., Chicago, IL)",[41,47],{"label":42,"type":43,"description":44,"interventionNames":45},"Rebamipide mouthwash","EXPERIMENTAL","Rebamipide mouthwash will be administered four times daily for one week or till healing",[46],"Drug: Rebamipide mouthwash",{"label":48,"type":49,"description":50,"interventionNames":51},"Betamethasone mouthwash","ACTIVE_COMPARATOR","Betamethasone mouthwash of will be administered four times daily for one week or till healing",[52],"Drug: Betamethasone mouthwash",[54,60],{"type":55,"name":42,"description":56,"armGroupLabels":57,"otherNames":58},"DRUG","Rebamipide (REB), 2-(4-chlorobenzoylamino)-3-\\[2(1H)-quinolinone-4-yl\\]-propionic acid, is commonly used in cases of gastric ulcers, gastritis, and dry eye syndrome",[42],[59],"topical rebamipide",{"type":55,"name":48,"description":61,"armGroupLabels":62,"otherNames":63},"Betamethasone is a potent glucocorticoid steroid. It is very soluble in water, and therefore it can be used as a mouthwash and has been used for symptomatic relief and treatment of recurrent aphthous ulcers",[48],[64],"topical betamethasone",[66,71],{"name":67,"role":68,"phone":69,"phoneExt":25,"email":70},"Mostafa Belal, MSc","CONTACT","01223384483","mostafa.belal@dentistry.cu.edu.eg",{"name":72,"role":68,"phone":73,"phoneExt":25,"email":74},"Sherine Ali, Professor","01280777749","Shereen.Ali@dentistry.cu.edu.eg",[76],{"facility":77,"status":78,"city":79,"state":25,"zip":25,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"Faculty of dentistry, Cairo University","RECRUITING","Cairo","Egypt","EG",{"type":83,"coordinates":84},"Point",[85,86],31.24967,30.06263,{"lat":86,"lon":85},[89,90],{"name":67,"role":68,"phone":69,"phoneExt":25,"email":70},{"name":72,"role":68,"phone":73,"phoneExt":25,"email":74},{"type":92,"investigatorFullName":93,"investigatorTitle":94,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Mostafa Belal Omar Marzouk","Principal investigator","100522592","phase-1-evaluation-of-topical-rebamipide-versus-topical-betamethasone-for-management-of-oral-ulcers-in-behcets-disease-100522592",false,"NCT06084624","Evaluation of Topical Rebamipide Versus Topical Betamethasone for Treatment of Oral Aphthous Ulcers","Evaluation of Topical Rebamipide Versus Topical Betamethasone for Treatment of Oral Aphthous Ulcers: A Randomized Clinical Trial","Inclusion criteria:\n\nPatients age from 18-70 years old. Patients with active oral ulcers. History of recurrent ulcers in the oral cavity Patients free from any visible oral lesions other than the oral aphthous ulcers.\n\nPatient who will agree to participate in the study and take the supplied interventions.\n\nE8glusion criteria:\n\n* Patients with history of a severe or chronic medical condition including congestive heart failure, malignancy and active infection including tuberculosis, hepatitis and human immunodeficiency virus.\n* Patients under immunosuppressive drugs.\n* Patients using topical or systemic treatment agents for the oral ulcers","ALL","18 Years","70 Years",{"count":106,"type":107},46,"ESTIMATED","INTERVENTIONAL",[110],"PHASE2","The goal of this randomized clinical trial is to to compare the effect of topical rebamipide to topical betamethasone on pain intensity in patients having recurrent oral aphthous ulcers. The main question it aims to answer is :\n\nWhat is the effect of topical Rebamipide mouthwash compared to topical betamethasone mouthwash on pain reduction in patients with oral aphthous ulcers?\n\nParticipants will will be divided randomly into the two groups and the following outcomes will be measured:\n\nPain associated with oral ulcers Number of oral ulcers Diameter of oral ulcers Healing time of oral ulcers",[113],"Oral Aphthous Ulcers",[115,116,117],"Oral aphthous ulcers","Oral ulcers","Aphthous ulceration","2026-10-01",{"date":120,"type":121},"2026-10-06","ACTUAL",{"date":123,"type":121},"2026-07-01",{"date":125,"type":107},"2027-06",{"name":5,"class":6},1]