Improving practice guidelines for the treatment of denture-related erythematous stomatitis: a study protocol for a randomized controlled trial

Denture biofilm is a complex layer of microorganisms, including bacteria and yeasts, embedded in an extracellular polysaccharide matrix [1, 2]. Toxins and metabolic waste produced by these microorganisms cause cell injury and inflammation [3, 4]. Evidence suggests that microorganisms commonly found in oral biofilms can play a role in the development of systemic conditions through various pathways of infection and inflammation [5‐8]. Thus, maintaining the oral microbial ecological equilibrium is critical because it plays a significant role in the prevention of oral diseases and their associated systemic complications [9]. However, many oral biofilm-mediated diseases continue to be treated based on outdated practice guidelines established with weak supporting evidence.

Practice guideline development is a complex process that is impeded by a lack of sound research and scientific evidence. This makes clinical decision-making a challenging task, potentially resulting in adverse consequences for patients, including misdiagnosis, maltreatment, overprescription of medications, unwanted side effects and harm, as well as depletion of resources of the health care system [10‐13]. In turn, these consequences may even lead to legal issues for healthcare providers.

Denture-related erythematous stomatitis (DES) is an example of a biofilm-mediated disease treated according to suboptimal practice guidelines. DES is a longstanding and recurrent inflammatory condition, mostly observed on the palatal mucosa and easily diagnosed during routine oral examination. Similar to other types of inflammation, it results from the host’s protective cell response to traumatic, chemical, or microbial cell injury, ensuing vasodilatation, increased microvascular permeability, and tissue edema [14, 15]. While often asymptomatic, some patients may present with mucosal tenderness and bleeding, halitosis, burning sensation, xerostomia, and dysphagia [16, 17]. DES is the most prevalent oral disease and the main indicator of poor oral health among the completely edentate population, affecting one in every three individuals wearing removable dental prostheses [18‐22]. A higher prevalence of DES is seen in older people, due to long-term denture use, lack of dexterity in performing oral hygiene, polymedication, and decreased host immunity [23, 24]. However, children and adults wearing acrylic partial dentures, obturator prostheses, and ortho-appliances can also be affected by DES [25‐27].

Because complete tooth loss can nowadays be considered a disease of poverty, DES is mostly seen in individuals with low socioeconomic status, who are less likely to visit health care professionals on a regular basis [22, 25, 28]. This may put this population at risk because studies have shown a link between this oral pathology and serious systemic diseases such as bacterial endocarditis and aspiration pneumonia. This is critical for hospitalized patients, individuals with a compromised immune system, and older people with cognitive impairments and dementia [5, 7, 29, 30].

Although the etiology of DES is still undiscovered, the literature at large suggests that this disease is multifactorial, with colonization by Candida albicans being the main risk factor [31]. Therefore, clinicians usually prescribe antifungals along with oral hygiene instructions and prosthesis adjustments [32‐34]. However, a high recurrence rate and recolonization by Candida after cessation of antifungal therapy are widely reported [35‐37]. Retreatment with antifungals is therefore common. This unjustified use of antifungal medication may expose patients to adverse effects over time, most notably medication resistance [38]. A recent meta-analysis on this topic showed the inefficacy of antifungals in the treatment of denture stomatitis [39]. Furthermore, several research findings question the etiological role of Candida spp. in the initiation of inflammation and suggest that candidal colonization may be secondary to tissue injury and inflammation [40, 41].

Current evidence highlights the need for providing new treatment guidelines for DES. Recent findings from the Emami et al. research group showed that brushing the palate is a promising alternative to antifungal medication [41]. However, these encouraging pilot results should be validated by a randomized controlled trial. A recent systematic review of different treatment methods for DES also highlighted the need for a randomized trial on soft tissue hygiene [42]. Therefore, the objective of this pragmatic clinical trial is to provide evidence on the effectiveness of palatal brushing for the treatment of DES. The knowledge gained from this study will help in developing clinical guidelines aimed at promoting the oral health of edentate individuals.