Pharmacological Management Optimization for Oral Mucosal Disorders: A Clinical Pharmacist Led Cluster Randomized Controlled Trial With Implementation Science Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 336
- 主要终点
- Prescribing Guideline Concordance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors responsible for prescription audits, adverse drug reaction assessment, and outcome evaluation will be blinded to cluster allocation. Data analysis will also be conducted by investigators blinded to group assignment. Due to the nature of the pharmacist-led intervention, participants, dentists, and pharmacists cannot be blinded.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Prescribing Guideline Concordance
时间窗: 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.
次要结局
- Medication adherence rate (%)(At baseline and at the end of the 9-month intervention phase (Month 12))
- Symptom Severity(At baseline and at the end of the 9-month intervention phase (Month 12))
- Oral Health-Related Quality of Life(At baseline and at the end of the 9-month intervention phase (Month 12))
- Adverse Drug Reactions (ADR)(Through study completion (18 months))
- Patient Counselling Quality(Throughout the 9-month intervention phase (Months 4-12))
研究者
Nabeel Ayappali Kalluvalappil
Lecturer
University of Fujairah