An interventional study of Pharmacist-Led Prescribing Optimization and Patient Counselling in Oral Lichen Planus, Recurrent Aphthous Stomatitis and Burning Mouth Syndrome, sponsored by University of Fujairah. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by University of Fujairah · Not applicable, Interventional, and Health services research
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.
This is a cluster-randomized interventional study evaluating a pharmacist-led model to improve prescribing quality and patient outcomes in the management of oral mucosal disorders. Dental clinic sessions (clusters) will be assigned to either an intervention arm or a usual-care control arm. The study includes patients diagnosed with oral lichen planus, recurrent aphthous stomatitis, burning mouth syndrome, herpes viral infection or oral candidiasis.
In the intervention clusters, a clinical pharmacist will support dentists through structured prescription audits, evidence-based feedback, standardized drug algorithms, patient counselling, and monitoring of medication adherence and adverse drug reactions. Control clusters will continue routine dental care without pharmacist involvement.
The study will begin with an external pilot phase to assess feasibility, refine workflows, and finalize study tools, followed by a baseline phase and then full implementation of the cluster-randomized trial. Primary outcomes include prescribing guideline concordance. Secondary outcomes include patient adherence, symptom severity, quality of life, and medication safety.
Process and implementation outcomes will be evaluated using the Capability-Opportunity-Motivation Behaviour (COM-B) model and the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to assess acceptability, feasibility, and sustainability of the intervention in real-world dental practice.
142 studies on the registry are indexed under Lichen Planus, Oral; 27 are open to participants now.
This study's planned enrollment of 336 is above the median of 39 across 101 interventional studies indexed under Lichen Planus, Oral.
Browse Lichen Planus, Oral studies →University of Fujairah is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will receive usual dental care supplemented by a pharmacist-led intervention. A clinical pharmacist will conduct structured prescription audits, provide evidence-based feedback to dentists, apply standardized drug algorithms for oral mucosal disorders, deliver patient counselling on medication use and adherence, and monitor adverse drug reactions. Medications prescribed may include topical corticosteroids (e.g., clobetasol propionate 0.05% gel/ointment applied 2-3 times daily for 2-4 weeks, fluticasone propionate spray off-label), topical antifungals (e.g., nystatin oral suspension or miconazole oral gel), and other supportive therapies as per standard care. The intervention continues throughout the study period.
Behavioral: Pharmacist-Led Prescribing Optimization and Patient Counselling
Participants in this arm will receive routine dental care for oral mucosal disorders according to existing clinical practice. Prescriptions, counselling, and follow-up will be provided at the discretion of the treating dentist, without pharmacist-led prescription audit, structured feedback, standardized counselling, or formal adverse drug reaction monitoring as part of the study protocol.
This 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.
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.
Time frame: Through the 9-month intervention phase (Months 4-12)
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).
Time frame: At baseline and at the end of the 9-month intervention phase (Month 12)
Symptom Severity
Change in patient-reported symptom severity (pain/burning sensation) measured using a numeric rating scale (0-10).
Time frame: At baseline and at the end of the 9-month intervention phase (Month 12)
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.
Time frame: At baseline and at the end of the 9-month intervention phase (Month 12)
Adverse Drug Reactions (ADR)
Incidence, type, severity, causality (WHO-UMC), and preventability (Schumock and Thornton criteria) of adverse drug reactions related to prescribed medications.
Time frame: Through study completion (18 months)
Patient Counselling Quality
Completion and quality of pharmacist-led counselling assessed using a standardized counselling checklist.
Time frame: Throughout the 9-month intervention phase (Months 4-12)
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.
Time frame: At the end of the 9-month intervention phase (Month 12)
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.
Time frame: At the end of the 9-month intervention phase (Month 12)
Reach (RE-AIM framework)
Percentage of eligible participants who receive the pharmacist-led intervention.
Time frame: Through study completion (18 months).
Adoption (RE-AIM framework)
Percentage of participating dentists implementing the pharmacist-led intervention.
Time frame: At the end of the 9-month intervention phase (Month 12)
Implementation fidelity (RE-AIM framework)
Percentage of intervention components delivered as intended according to the study protocol.
Time frame: Throughout the 9-month intervention phase (Months 4-12)
Maintenance (RE-AIM framework)
Continuation of pharmacist-led prescribing practices after withdrawal of active support, assessed during the sustainability phase.
Time frame: At the end of the 18-month study period.
No study locations are listed for this record.
Plan to share: No
Start is estimated for Jul 2026; primary completion for Nov 2027, 16 months later.
Of 20 interventional studies with no phase under Lichen Planus, Oral, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 27. This study's planned 16 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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University of Fujairah