Burning Mouth Syndrome, Herpes Virus Infection, Oral Candidiasis, Oral Lichen Planus, Recurrent Aphthous Stomatitis
Conditions
Keywords
Oral Mucosal Diseases, Oral Lichen Planus, Recurrent Aphthous Stomatitis, Burning Mouth Syndrome, Oral Candidiasis, Medication Therapy Management, Drug Prescriptions, Patient Compliance
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALPharmacist-Led Prescribing Optimization and Patient Counselling
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.
Sponsors
University of Fujairah
Sri Balaji Vidyapeeth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors responsible for prescription audits, adverse drug reaction assessment, and outcome evaluation will be blinded to cluster allocation. Data analysis will also be conducted by investigators blinded to group assignment. Due to the nature of the pharmacist-led intervention, participants, dentists, and pharmacists cannot be blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Able and willing to provide written informed consent
Exclusion criteria
* 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 * Patients unable to comply with follow-up or study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prescribing Guideline Concordance | Through the 9-month intervention phase (Months 4-12) | 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
| Measure | Time frame | Description |
|---|---|---|
| Medication adherence rate (%) | At baseline and at the end of the 9-month intervention phase (Month 12) | 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 | At baseline and at the end of the 9-month intervention phase (Month 12) | Change in patient-reported symptom severity (pain/burning sensation) measured using a numeric rating scale (0-10). |
| Oral Health-Related Quality of Life | At baseline and at the end of the 9-month intervention phase (Month 12) | 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) | Through study completion (18 months) | Incidence, type, severity, causality (WHO-UMC), and preventability (Schumock and Thornton criteria) of adverse drug reactions related to prescribed medications. |
| Patient Counselling Quality | Throughout the 9-month intervention phase (Months 4-12) | Completion and quality of pharmacist-led counselling assessed using a standardized counselling checklist. |
Contacts
CONTACTNabeel Ayappali Kalluvalappil
STUDY_CHAIRTamer Hassan
Gulf Medical University
STUDY_DIRECTORRamam Sripada
Sri Balaji Vidyapeeth University
PRINCIPAL_INVESTIGATORNasma Pulikkalakath
Sri Balaji Vidyapeeth University
Outcome results
None listed