Mouth and Orofacial Health Indexing and Individualized Treatment (Mohit) Plan for Patients with Brain Injury: Study Protocol for Experimental and Observational Trial

Abstract

Background Various countries have oral care clinical guidelines for at-risk populations, but they are generic and difficult to follow. The bidirectional association between oral health and systemic complications is usually not prioritized when designing the oral care plan for this population.

Aim To develop an evidence-based oral health tool and treatment plan [Mouth and Orofacial Health Indexing and individualized Treatment (MOHIT)], which can be employed in the clinical setting for individuals with acquired brain injury (ABI). In addition, a comprehensive evaluation of orofacial function, frailty, nutrition, swallowing disorders, and temporomandibular disorders (TMD) should be performed to evaluate the association between disease and potential risk factors.

Methods The ongoing project (February 2023-July 2024) is an observational and experimental trial where a three-week oral care plan is rolled out to ABI individuals admitted at a neuro-rehabilitation center with two arms: a) an existing oral care plan (EOCP) or b) a new oral care plan (MOHIT). Power calculation yields at least 120 participants to be enrolled. The EOCP (control) group will have a hospital-based routine oral care plan, while the MOHIT plan consists of a) individualized (with or without self-care and/or with or without dysphagia), b) item-wise (tooth, tongue, gingiva, odor, saliva, mucous membrane, lips and candidiasis), and c) structured oral care plan built on two-step assessment process (screening and clinical). The two-step assessment will be performed on individuals in each group by a trained dentist at admission (baseline) and in week 4 as an outcome measurement. A 3-week oral care plan is handled by clinical nurses of the respective wards under the MOHIT/EOCP plan. For individuals with the poorest oral health, microbiological sampling will be taken to explore the oral pathogen community in the ABI population. In addition, validated questionnaires, screening and objective assessment tools are used to assess orofacial function, frailty, nutrition, swallowing disorders and TMD to evaluate its presence, severity, impact and associations between disease and risk factors.

Expected outcome and future perspective. The project will create an evidence-based individualized and item-wise diagnostic and treatment plan. In addition, the project will provide a detailed method of evaluating orofacial function, frailty, nutrition, swallowing disorders and TMD within this population. We expect to structure, standardize and improve oral diagnostics, oral care and oral rehabilitation plans, along with improving clinical staff skills.

Note:
Funding Information: MK received Health Research Fund of the Central Denmark Region grant (A3098) to conduct the project. All authors´ salary are supported by their respective institutions. The oral care products are donated by Bluereo, South Korea (electric suction toothbrush) and Sunstar, Switzerland (manual and electric sonic toothbrush, mouthwash, tongue scrapper etc.).

Declaration of Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Ethics Approval Statement: The project was notified to the Central Denmark Region Committee on Health Research Ethics with case number: 1-10-72-124-22. According to the Danish Consolidation Act on Research Ethics Review of Health Research Projects with Consolidation Act number 1338 of 1 September 2020 section 14 (1), the committee did not consider the current project as a health research project (section 2 (1)) and concluded it as a “clinical quality development project”. Hence, no ethical approval and no written informed consent is required from the participants. However, the permission of the institutional review board for clinical project was taken under case number: 196525. This study will be performed in accordance with the Helsinki Declaration II. Participants will be informed about their participation through verbal and written project information and their free will to decline at any time of the project.

Keywords: stroke, Neurorehabilitation, oral care, orofacial health, dysphagia, malnutrition