Improving Prescribing Quality for Oral Mucosal Disorders Using a Pharmacist-Led Model

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Fujairah

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Pharmacist-Led Prescribing Optimization and Patient Counselling

    Behavioral

    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.

Treatment groups

336 Participants
are divided into 2 treatment groups
Group A: Intervention Arm: Pharmacist-Led Prescribing OptimizationExperimental treatment 1 intervention
Group B: Control Arm: Usual Dental CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

1

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)
2

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)
3

Reach (RE-AIM framework)

Percentage of eligible participants who receive the pharmacist-led intervention.

Time frame
Through study completion (18 months).
4

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)

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Fujairah

Lead sponsor

Sri Balaji Vidyapeeth University

Collaborator

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