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

19. juli 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

336

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Prescribing Guideline Concordance
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Medication adherence rate (%)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Dentist acceptability score
Tidsramme: 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
Tidsramme: 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)
Tidsramme: Through study completion (18 months).
Percentage of eligible participants who receive the pharmacist-led intervention.
Through study completion (18 months).
Adoption (RE-AIM framework)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Fujairah

Samarbejdspartnere

Sri Balaji Vidyapeeth University

Efterforskere

  • Studiestol: Tamer Hassan, Gulf Medical University
  • Studieleder: Ramam Sripada, Sri Balaji Vidyapeeth University
  • Ledende efterforsker: Nasma Pulikkalakath, Sri Balaji Vidyapeeth University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

30. november 2027

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

21. juni 2026

Først indsendt, der opfyldte QC-kriterier

19. juli 2026

Først opslået (Faktiske)

22. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EA#65

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