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

NCT07721090 | Not Yet Recruiting DMC

• 1 other identifier: EA#65
• Study Type: interventional
• Target: 336
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Oral Lichen Planus; Burning Mouth Syndrome; Herpes Virus Infection; Oral Candidiasis; Recurrent Aphthous Stomatitis

Keywords

Oral Mucosal Diseases; Oral Lichen Planus; Recurrent Aphthous Stomatitis; Burning Mouth Syndrome; Oral Candidiasis; Medication Therapy Management; Drug Prescriptions; Patient Compliance

Outcome Measures

Primary Outcomes (1)

• Prescribing Guideline Concordance

  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)

Secondary Outcomes (5)

• 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)

Other Outcomes (6)

• Dentist acceptability score

  At the end of the 9-month intervention phase (Month 12)

• Patient acceptability score

  At the end of the 9-month intervention phase (Month 12)

• Reach (RE-AIM framework)

  Through study completion (18 months).

Study Arms (2)

Intervention Arm: Pharmacist-Led Prescribing Optimization

EXPERIMENTAL

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.

Behavioral: Pharmacist-Led Prescribing Optimization and Patient Counselling

Control Arm: Usual Dental Care

NO INTERVENTION

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.

Interventions

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.

Intervention Arm: Pharmacist-Led Prescribing Optimization

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Fujairah: lead
• Sri Balaji Vidyapeeth University: collaborator

Related Publications (11)

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  PMID: 26547687 BACKGROUND

• 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.

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  PMID: 22244162 BACKGROUND

• 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.

  PMID: 28217433 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

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• 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.

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• 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.

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  PMID: 38530258 BACKGROUND

MeSH Terms

Conditions

Lichen Planus, Oral; Stomatitis, Aphthous; Burning Mouth Syndrome; Candidiasis, Oral; Herpesviridae Infections; Patient Compliance

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Stomatitis; Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; DNA Virus Infections; Virus Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Tamer Hassan

  Gulf Medical University

  STUDY CHAIR

• Ramam Sripada

  Sri Balaji Vidyapeeth University

  STUDY DIRECTOR

• Nasma Pulikkalakath

  Sri Balaji Vidyapeeth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nabeel Ayappali Kalluvalappil

CONTACT

+97192023517; n.kalluvalappil@fu.ac.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 21, 2026
• First Posted: July 22, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share