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

Official title

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

Overview

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.

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.

Interventions

• 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, me

Primary outcome measures

• Prescribing Guideline Concordance [Time frame: Through the 9-month intervention phase (Months 4-12)]

Secondary outcome measures (5)

• Medication adherence rate (%) [Time frame: 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)]
• Oral Health-Related Quality of Life [Time frame: 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)]
• Patient Counselling Quality [Time frame: Throughout the 9-month intervention phase (Months 4-12)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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. PMID 26547687
• 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. PMID 34051788
• 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. PMID 22244162
• 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 Soc PMID 28217433
• 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. PMID 34760748
• 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. PMID 39611172
• 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. PMID 37133630
• 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. PMID 40650560

Identifiers

NCT: NCT07721090 · EA#65

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗