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

July 19, 2026 updated by: Nabeel Ayappali Kalluvalappil, University of Fujairah

Pharmacological Management Optimization for Oral Mucosal Disorders: A Clinical Pharmacist Led Cluster Randomized Controlled Trial With Implementation Science Evaluation

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

336

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm: Pharmacist-Led Prescribing Optimization
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
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.
No Intervention: Control Arm: Usual Dental Care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prescribing Guideline Concordance
Time Frame: 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.
Through the 9-month intervention phase (Months 4-12)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication adherence rate (%)
Time Frame: 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).
At baseline and at the end of the 9-month intervention phase (Month 12)
Symptom Severity
Time Frame: 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).
At baseline and at the end of the 9-month intervention phase (Month 12)
Oral Health-Related Quality of Life
Time Frame: 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.
At baseline and at the end of the 9-month intervention phase (Month 12)
Adverse Drug Reactions (ADR)
Time Frame: 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.
Through study completion (18 months)
Patient Counselling Quality
Time Frame: Throughout the 9-month intervention phase (Months 4-12)
Completion and quality of pharmacist-led counselling assessed using a standardized counselling checklist.
Throughout the 9-month intervention phase (Months 4-12)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dentist acceptability score
Time Frame: At the end of the 9-month intervention phase (Month 12)
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.
At the end of the 9-month intervention phase (Month 12)
Patient acceptability score
Time Frame: At the end of the 9-month intervention phase (Month 12)
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.
At the end of the 9-month intervention phase (Month 12)
Reach (RE-AIM framework)
Time Frame: Through study completion (18 months).
Percentage of eligible participants who receive the pharmacist-led intervention.
Through study completion (18 months).
Adoption (RE-AIM framework)
Time Frame: At the end of the 9-month intervention phase (Month 12)
Percentage of participating dentists implementing the pharmacist-led intervention.
At the end of the 9-month intervention phase (Month 12)
Implementation fidelity (RE-AIM framework)
Time Frame: Throughout the 9-month intervention phase (Months 4-12)
Percentage of intervention components delivered as intended according to the study protocol.
Throughout the 9-month intervention phase (Months 4-12)
Maintenance (RE-AIM framework)
Time Frame: At the end of the 18-month study period.
Continuation of pharmacist-led prescribing practices after withdrawal of active support, assessed during the sustainability phase.
At the end of the 18-month study period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Fujairah

Collaborators

Sri Balaji Vidyapeeth University

Investigators

  • Study Chair: Tamer Hassan, Gulf Medical University
  • Study Director: Ramam Sripada, Sri Balaji Vidyapeeth University
  • Principal Investigator: Nasma Pulikkalakath, Sri Balaji Vidyapeeth University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

June 21, 2026

First Submitted That Met QC Criteria

July 19, 2026

First Posted (Actual)

July 22, 2026

Study Record Updates

Last Update Posted (Actual)

July 22, 2026

Last Update Submitted That Met QC Criteria

July 19, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA#65

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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