Improving Prescribing Quality for Oral Mucosal Disorders Using a Pharmacist-Led Model
19 luglio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Stimato)
336
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Nabeel Ayappali Kalluvalappil
- Numero di telefono: +97192023517
- Email: n.kalluvalappil@fu.ac.ae
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
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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.
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Nessun intervento: 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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Prescribing Guideline Concordance
Lasso di tempo: 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.
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Through the 9-month intervention phase (Months 4-12)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Medication adherence rate (%)
Lasso di tempo: 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).
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At baseline and at the end of the 9-month intervention phase (Month 12)
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Symptom Severity
Lasso di tempo: At baseline and at the end of the 9-month intervention phase (Month 12)
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Change in patient-reported symptom severity (pain/burning sensation) measured using a numeric rating scale (0-10).
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At baseline and at the end of the 9-month intervention phase (Month 12)
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Oral Health-Related Quality of Life
Lasso di tempo: 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.
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At baseline and at the end of the 9-month intervention phase (Month 12)
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Adverse Drug Reactions (ADR)
Lasso di tempo: 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.
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Through study completion (18 months)
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Patient Counselling Quality
Lasso di tempo: 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)
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Dentist acceptability score
Lasso di tempo: 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)
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Patient acceptability score
Lasso di tempo: 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.
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At the end of the 9-month intervention phase (Month 12)
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Reach (RE-AIM framework)
Lasso di tempo: Through study completion (18 months).
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Percentage of eligible participants who receive the pharmacist-led intervention.
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Through study completion (18 months).
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Adoption (RE-AIM framework)
Lasso di tempo: At the end of the 9-month intervention phase (Month 12)
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Percentage of participating dentists implementing the pharmacist-led intervention.
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At the end of the 9-month intervention phase (Month 12)
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Implementation fidelity (RE-AIM framework)
Lasso di tempo: Throughout the 9-month intervention phase (Months 4-12)
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Percentage of intervention components delivered as intended according to the study protocol.
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Throughout the 9-month intervention phase (Months 4-12)
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Maintenance (RE-AIM framework)
Lasso di tempo: At the end of the 18-month study period.
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Continuation of pharmacist-led prescribing practices after withdrawal of active support, assessed during the sustainability phase.
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At the end of the 18-month study period.
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Cattedra di studio: Tamer Hassan, Gulf Medical University
- Direttore dello studio: Ramam Sripada, Sri Balaji Vidyapeeth University
- Investigatore principale: Nasma Pulikkalakath, Sri Balaji Vidyapeeth University
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Klimek L, Bergmann KC, Biedermann T, Bousquet J, Hellings P, Jung K, Merk H, Olze H, Schlenter W, Stock P, Ring J, Wagenmann M, Wehrmann W, Mosges R, Pfaar O. Visual analogue scales (VAS): Measuring instruments for the documentation of symptoms and therapy monitoring in cases of allergic rhinitis in everyday health care: Position Paper of the German Society of Allergology (AeDA) and the German Society of Allergy and Clinical Immunology (DGAKI), ENT Section, in collaboration with the working group on Clinical Immunology, Allergology and Environmental Medicine of the German Society of Otorhinolaryngology, Head and Neck Surgery (DGHNOKHC). Allergo J Int. 2017;26(1):16-24. doi: 10.1007/s40629-016-0006-7. Epub 2017 Jan 19.
- Papagiannopoulou V, Oulis CJ, Papaioannou W, Antonogeorgos G, Yfantopoulos J. Validation of a Greek version of the oral health impact profile (OHIP-14) for use among adults. Health Qual Life Outcomes. 2012 Jan 14;10:7. doi: 10.1186/1477-7525-10-7.
- Shukla AK, Jhaj R, Misra S, Ahmed SN, Nanda M, Chaudhary D. Agreement between WHO-UMC causality scale and the Naranjo algorithm for causality assessment of adverse drug reactions. J Family Med Prim Care. 2021 Sep;10(9):3303-3308. doi: 10.4103/jfmpc.jfmpc_831_21. Epub 2021 Sep 30.
- Harden SM, Gaglio B, Shoup JA, Kinney KA, Johnson SB, Brito F, Blackman KC, Zoellner JM, Hill JL, Almeida FA, Glasgow RE, Estabrooks PA. Fidelity to and comparative results across behavioral interventions evaluated through the RE-AIM framework: a systematic review. Syst Rev. 2015 Nov 8;4:155. doi: 10.1186/s13643-015-0141-0.
- Willmott TJ, Pang B, Rundle-Thiele S. Capability, opportunity, and motivation: an across contexts empirical examination of the COM-B model. BMC Public Health. 2021 May 29;21(1):1014. doi: 10.1186/s12889-021-11019-w.
- Rohay JM, Dunbar-Jacob JM. Variation in adherence measures as a function of calculation methods. Front Pharmacol. 2024 Nov 13;15:1460327. doi: 10.3389/fphar.2024.1460327. eCollection 2024.
- Yoshida K, Watanabe S, Hoshino N, Pak K, Hidaka N, Konno N, Nakai M, Ando C, Yabuki T, Suzuki N, Katsura K, Tomihara K, Toyama A. Hospital pharmacist interventions for the management of oral mucositis in patients with head and neck cancer receiving chemoradiotherapy: a multicenter, prospective cohort study. Support Care Cancer. 2023 May 3;31(5):316. doi: 10.1007/s00520-023-07784-6.
- Bakhshi F, Mitchell R, Khosravi A, Antikchi M. Guideline adherence for controlling incidence of medication errors: a systematic mixed-method review. Int J Pharm Pract. 2025 Oct 3;33(5):477-493. doi: 10.1093/ijpp/riaf049.
- Shetty Y, Kamat S, Tripathi R, Parmar U, Jhaj R, Banerjee A, Balakrishnan S, Trivedi N, Chauhan J, Chugh PK, Tripathi CD, Badyal DK, Solomon L, Kaushal S, Gupta K, Jayanthi M, Jeevitha G, Chatterjee S, Samanta K, Desai C, Shah S, Medhi B, Joshi R, Prakash A, Gupta P, Roy A, Chandy S, Ranjalkar J, Bright HR, Dikshit H, Mishra H, Roy SS, Kshirsagar N. Evaluation of prescriptions from tertiary care hospitals across India for deviations from treatment guidelines & their potential consequences. Indian J Med Res. 2024 Feb 1;159(2):130-141. doi: 10.4103/ijmr.ijmr_2309_22. Epub 2024 Apr 4.
- Teoh L, Moses G, McCullough MJ. A review and guide to drug-associated oral adverse effects-Oral mucosal and lichenoid reactions. Part 2. J Oral Pathol Med. 2019 Aug;48(7):637-646. doi: 10.1111/jop.12910. Epub 2019 Jun 26.
- Stoopler ET, Villa A, Bindakhil M, Diaz DLO, Sollecito TP. Common Oral Conditions: A Review. JAMA. 2024 Mar 26;331(12):1045-1054. doi: 10.1001/jama.2024.0953.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 luglio 2026
Completamento primario (Stimato)
30 novembre 2027
Completamento dello studio (Stimato)
31 dicembre 2027
Date di iscrizione allo studio
Primo inviato
21 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
19 luglio 2026
Primo Inserito (Effettivo)
22 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
22 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
19 luglio 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie della bocca
- Malattie stomatognatiche
- Infezioni
- Malattie virali
- Infezioni da virus del DNA
- Eruzioni lichenoidi
- Malattie della pelle, papulosquamose
- Malattie della pelle
- Infezioni batteriche e micosi
- Micosi
- Candidosi
- Stomatite
- Comportamento
- Malattie della pelle e del tessuto connettivo
- Lichen Planus
- Aderenza e conformità al trattamento
- Comportamento sanitario
- Accettazione dell'assistenza sanitaria da parte del paziente
- Lichen planus, orale
- Infezioni da Herpesviridae
- Stomatite, Afto
- Sindrome della bocca che brucia
- Candidosi, Orale
- Conformità del paziente
Altri numeri di identificazione dello studio
- EA#65
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .