Faculty of Dentistry
Cairo, 11728, Egypt
NCT Number: NCT04765267
Treatment of oral lichen planus is challenging. Diverse therapeutic modalities have been suggested, but a permanent cure is not yet available. In some OLP patients, topical corticosteroid alone is not sufficiently enough, thus it may require a supplementation to augment its effect. Micronutrients are gaining more attention as therapeutic modalities in immunologic disorders. Researchers are recommended to conduct further clinical studies are to assess the role of these elements in management of OLP (Gholizadeh & Sheykhbahaei, 2020). Among the less visited micronutrients are zinc and vitamin D. This trial will assess their role in management of OLP.
Looking for future studies?
Notify MeAll sexes
Interventional
Not applicable
Cairo, 11728, Egypt
The enrolled patients will be divided randomly into three groups. One group will receive topical Corticosteroid (Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm) four times daily, the second group will receive topical Corticosteroid (Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm) four times daily with systemic zinc (Octozinc: Zinc sulphate heptahydrate 25 mg tablets - October Pharma) twice daily and the third group will receive topical Corticosteroid (Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm) four times daily with systemic vitamin D (Cholecalciferol: vitamin D3 15 ml oral solution - Medical Union Pharmaceuticals) once daily. The patients will be recalled weekly for eight weeks. For every four weeks of topical corticosteroid application, topical oral antifungal (Daktarin 2% oral gel - miconazole) will be prescribed, four times daily for one week, to all the patients in the trial, to avoid secondary infection with oral candidiasis. The patients will be asked to prohibit the use of any topical or systemic medication during the trial.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dietary supplements
Other names: Cholecalciferol: vitamin D3 oral solution
Time frame: baseline (week 0), daily in week 1, week 1,week 2, week 3, week 4, week 5, week 6 and week 7
Visual analogue scale (0-10)
Time frame: baseline (week 0), week 1,week 2, week 3, week 4, week 5, week 6 and week 7
measured using Thongprasom et al. scoring system
Cairo University
Other
Evaluation of Micronutrients With Topical Corticosteroid Versus Topical Corticosteroid in Management of Symptomatic Oral Lichen Planus: Three-arm Randomized Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07536737
Lichen Planus, Lichen Planus, Oral
Bialystok, Podlaskie Voivodeship, Poland
View Trial DetailsNCT05401201
Dental Deposits, Dental Plaque
Tampere, Pirkanmaa, Finland
View Trial DetailsNCT07416318
Head and Neck Neoplasms, Leukoplakia
Kocaeli, Turkey (Türkiye)
View Trial DetailsNCT07414797
Biopsy, Lichen Planus
Roma, RM, Italy
View Trial Details