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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
336
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)
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