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NCT Number: NCT07721090

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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.

  4. 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.

  5. 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.

Other outcomes

  1. 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.

  2. 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.

  3. Reach (RE-AIM framework)

    Time frame: Through study completion (18 months).

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

  4. 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.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nabeel Ayappali Kalluvalappil

CONTACT

[email protected]

+97192023517

Sponsors and collaborators

Lead sponsor

University of Fujairah

Other

Collaborators

  • Sri Balaji Vidyapeeth University

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 22, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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