About this trial
This study aims to improve how oral mucosal disorders-such as oral lichen planus, recurrent aphthous stomatitis, burning mouth syndrome, herpes viral infection and oral candidiasis-are treated in dental settings. A pharmacist will work with dentists to review prescriptions, provide feedback, counsel patients, and monitor medication safety. Dental clinics will be assigned to either the pharmacist-led model or usual care. The study will evaluate whether this approach improves prescribing quality, patient adherence, symptom control, and safety. The findings may help establish a more standardized, effective way to manage these common oral conditions in routine dental practice.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years and above
Diagnosed with an oral mucosal disorder (oral lichen planus, recurrent aphthous stomatitis, burning mouth syndrome, Herpes viral infection or oral candidiasis)
Attending participating dental clinic sessions during the study period
Prescribed pharmacological treatment for the oral mucosal condition
Disqualifiers
Patients without a confirmed diagnosis of an oral mucosal disorder
Patients requiring immediate emergency care or hospitalization
Patients currently enrolled in another interventional clinical trial
Known hypersensitivity to commonly prescribed medications used in the study
Trial design
Parallel
Treatments tested in this trial
Pharmacist-Led Prescribing Optimization and Patient Counselling
BehavioralThis intervention involves a structured, pharmacist-led model integrated into routine dental care for patients with oral mucosal disorders. A clinical pharmacist will review dental prescriptions using standardized, evidence-based drug algorithms; provide audit and feedback to dentists; deliver structured patient counselling focused on correct medication use and adherence; and monitor for adverse drug reactions using validated tools. The intervention targets improvement in prescribing quality, medication safety, and patient outcomes, without introducing investigational drugs or altering standard treatment choices.
Treatment groups
Trial outcomes
Primary outcomes
Prescribing Guideline Concordance
Proportion of prescriptions that are fully concordant with predefined, evidence-based treatment guidelines for oral mucosal disorders, as assessed using a standardized prescription audit checklist.
Secondary outcomes
Medication adherence rate (%)
Percentage of prescribed doses taken, determined using a standardized adherence assessment combining self-reported adherence with objective measures (pill count or topical medication usage assessment, as applicable).
Symptom Severity
Change in patient-reported symptom severity (pain/burning sensation) measured using a numeric rating scale (0-10).
Oral Health-Related Quality of Life
Change in oral health-related quality of life measured using the Oral Health Impact Profile-14 (OHIP-14). The OHIP-14 total score ranges from 0 to 28, with higher scores indicating poorer oral health-related quality of life.
Adverse Drug Reactions (ADR)
Incidence, type, severity, causality (WHO-UMC), and preventability (Schumock and Thornton criteria) of adverse drug reactions related to prescribed medications.
Other outcomes
Dentist acceptability score
Dentist acceptability of the pharmacist-led intervention assessed using a structured questionnaire based on the Capability, Opportunity, Motivation-Behaviour (COM-B) framework. Higher scores indicate greater acceptability.
Patient acceptability score
Patient acceptability of the pharmacist-led intervention assessed using a structured questionnaire based on the Capability, Opportunity, Motivation-Behaviour (COM-B) framework. Higher scores indicate greater acceptability.
Reach (RE-AIM framework)
Percentage of eligible participants who receive the pharmacist-led intervention.
Adoption (RE-AIM framework)
Percentage of participating dentists implementing the pharmacist-led intervention.
Locations
Sponsors and contacts
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University of Fujairah
Lead sponsor
Sri Balaji Vidyapeeth University
Collaborator
This trial is not recruiting at the moment. You can still explore other options: