Improving Prescribing Quality for Oral Mucosal Disorders Using a Pharmacist-Led Model | NCT07721090

NCT07721090

Overview

NCT ID: NCT07721090
Lead Sponsor: University of FujairahOTHER
Official Title: Pharmacological Management Optimization for Oral Mucosal Disorders: A Clinical Pharmacist Led Cluster Randomized Controlled Trial With Implementation Science Evaluation
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.
Conditions: Oral Lichen Planus

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 22, 2026Actual
Start Date: Jul 1, 2026Estimated
Primary Completion Date: Nov 30, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 336Estimated
Primary Purpose: Health Services Research
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: Nabeel Ayappali KalluvalappilContact
n.kalluvalappil@fu.ac.ae+97192023517

Similar Studies

Participant Group/Arms

Intervention Arm: Pharmacist-Led Prescribing OptimizationExperimental

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

Control Arm: Usual Dental CareNo Intervention

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.