Evaluation of the effectiveness of moisturizing toothpaste in patients with medical-induced dry mouth (pilot study)

Introduction

Saliva is a native lubricant that increases the mobility of the mucous membranes of the mouth and lips during acts of speech, chewing, swallowing, and also, wetting the food lump, washes away microorganisms, neutralizes some of them in places of direct contact with tissues and reduces the risk of mechanical injury of the latter [1,2]. Reducing the level of salivation leads to the emergence of first hygienic problems, and then to the appearance of caries and inflammatory diseases of the oral cavity. The less saliva is secreted, the more difficult it is to carry out high-quality atraumatic dental measures aimed at sanitizing the oral cavity and improving the quality of life of the patient [3].

Dryness of the oral cavity is an important problem of modern dentistry. This condition often bothers patients with various diseases of human organs and systems or occurs as a temporary phenomenon during excitement, heavy physical work and against the background of taking medications, including in the treatment of diseases of the cardiovascular, nervous, musculoskeletal and other systems [4]. In addition, life expectancy has increased significantly over the last century and, consequently, the number of people with acute and chronic diseases will increase, and the likelihood that undesirable drug reactions associated with taking drugs will occur more often [5]. Numerous studies show that the use of moisturizing toothpastes can positively affect the quality of life of patients suffering from dry mouth syndrome [6,7]

As a consequence of dry mouth: the oral mucosa can be subjected to traumatization, galvanosis and halitosis, the risk of periodontal diseases, as well as dental caries, increases, especially in areas where manual hygiene is difficult. Also in the literature, there are cases of voice changes, reduced verbal activity, or the appearance of habits to wet the lips and / or oral mucosa. In more complex cases, with severe xerostomia, saliva substituents are used, which contribute to functional relief [8,9]. If xerostomia the mucous membrane of the oral cavity is in constant need of daily moisturizing. The optimal method of relieving the condition of patients is to stimulate secretion and mandatory use of moisturizers for the oral mucosa [10].

Aim

To evaluate the effectiveness of moisturizing toothpaste in patients with drug-induced dry mouth during therapy of underlying disease.

Materials and methods

The study involved 86 patients who had complaints of dry mouth during the survey. The questionnaires were developed by the authors themselves and included criteria by which patients ' complaints could be evaluated. According to the criteria for study inclusion (Table 1) out of 86, 40 patients were selected and assigned to the first group. The mean age of these patients was 57.6±7.3 yo, the duration of the underlying disease was 11±4.9 years. The second, control group, included 40 volunteers without or with rare complaints of dry mouth, whose mean age was 56.1±8.2 yo and who did not receive any medications on a regular basis. The clinical part of the study was carried out in the dental clinics "Vin-Clinic" and "Novodenta" (Moscow), as well as in the Department of Maxillofacial Surgery and Dentistry of Samara State Medical University.

Table 1. Criteria for inclusion, non-inclusion and exclusion from the study

During the primary patient examination in two groups, the initial level of oral hygiene efficiency index was determined (Podshadley, Haley-1968). Also, according to the results of the Oral Health Impact Profile-14 (OHIP-14) questionnaire, the quality of life was assessed among patients taking antianginal, antihypertensive drugs and the control group. Also, by conducting a first group survey, we identified the types of drugs that are used in the complex therapy of cardiovascular diseases in these patients.

All patients were explained the study phases and after that they signed an informed voluntary consent.

The working hypothesis was based on two assumptions:

1) Subjective feeling of dryness in the oral cavity negatively affects the quality of life in socially active people;

2) The use of moisturizing toothpaste allows correcting patient’s subjective feelings, as well as improving the level of hygiene by reducing the viscosity of saliva.

All patients were individually trained in oral hygiene with a toothbrush, proxy brush and floss.

The study protocol was as follows:

1. Determination of the initial level of hygiene and staining of the biofilm with a specialized dye;

2. Air-abrasive technology using a glycine-based powder with a particle size of 65 microns (VladMiVa);

3. In the presence of mineralized formations, treatment with an ultrasonic tip was carried out;

4. Polishing teeth with rotating rubber caps and paste.

After performing professional oral hygiene, all patients were selected for oral care at home: in the first group, the study participants were recommended to use PRESIDENT PROFI AQUA Xerostomed toothpaste (RDA 75), in the second group (control group) – toothpaste (RDA 75) without SLS. All patients were prescribed individual oral hygiene 2 times per day for 3 minutes.

In the composition of the toothpaste used by the participants of the study group, there are Sodium PCA, betaine, mallow, xylitol. The choice of this combination is based on the need to increase cariesogenic flora resistance, the proliferation of which occurs when the biofilm grows and the quality of saliva deteriorates.

Examinations of both groups of patients were carried out twice: after 15 days and after 1 month. It should be noted that this is a pilot study and was aimed at a qualitative effectiveness evaluation of the developed toothpaste.

Student's t-test was used for statistical analysis of the study results.

Results

We found a decrease in the quality of life due to dry mouth, especially in socially active people.

Among all study participants, both with cardiovascular diseases who received drugs that affect saliva secretion, and in individuals from the control group who occasionally noted the appearance of dryness in the oral cavity, there was an improvement in the quality of life according to the questionnaire "Oral Health Impact Profile-14 (OHIP-14)" from 44.3±0.4 (p<0.001) to 25.2±0.3 (p<0.05 compared to primary data). At the same time, among healthy volunteers, there was a positive subjective perception of toothpaste and a slight improvement in the quality of life from 16.7±0.1 (p<0.001) to 14.1±0.2 (p<0.05 compared to the primary data). The data are presented in Table 2.

The majority of patients determined a positive subjective perception of moisturizing toothpaste: a feeling of "moistened" oral cavity; good tolerability; no astringent effect; no allergic reactions.

Table 2. Quality of life results

In most cases, patients suffering from cardiovascular diseases took beta-blockers and angiotensin II receptor blockers, less often used imidazoline receptor agonists, diuretics, angiotensin-converting enzyme inhibitors and slow calcium channel blockers (calcium antagonists).

Evaluation of the Oral Hygiene Efficiency Index (PHP) confirms the second working hypothesis: the use of moisturizing toothpaste can improve the level of hygiene by reducing the viscosity of saliva. Initially, we observed an unsatisfactory level in both the study group (2.1±0.3) and the control group (1.8±0.1). Analyzing the data obtained, we observe an improvement in the index indicators already on the 15th day of the study by 61.9% in the study group (1.3±0.2) and by 66.7% in the control group (1.2±0.1). In this case, the results reliability is determined when compared with the control group.

Table 3. Oral Hygiene Efficiency Index (PHP) results

A month later, on exam in the study group, we determined an improvement in the index to lower limit of satisfactory values (0.7±0.1), which in comparison with the intermediate situation is 53.85%, and in the control group, the index reached good values (0.6±0.2), accounting for a 50% increase in effectiveness. The data is presented in Table 3.

Thus, the pilot study showed the clinical effectiveness of moisturizing toothpaste (active ingredients-Sodium PCA, betaine, mallow, xylitol) in patients with drug-induced dryness of the oral cavity due to therapy of the underlying disease.

Discussion

The problem of secondary xerostomia, dryness of the oral cavity caused by taking medications that affect the activity of salivary gland acinuses, remains relevant to our day [11]. Not all patients understand that dryness of the oral cavity is caused by the undesirable effect of drugs prescribed for the treatment of the underlying disease. For early detection of hyposalivation, the dentist while collecting medical history should not forget to ask the patient about all medications received by the patient. To simplify this procedure, clarifying questions should be included in the questionnaires filled out by patients, paying special attention to the groups of medicines and their connection with the appearance of dry mouth syndrome. Taking into account the main therapy, all patients who are treated with drugs that inhibit the production of saliva by the salivary glands are recommended to use toothpastes that enhance the moistening of the oral mucosa. Following the generally accepted recommendations of dentists world community to reduce the likelihood of developing caries and its complications, patients with a mucous membrane disorders professional oral hygiene should be carried out in right time. Thus, according to Shi Z.C. and Aloy-Prósper A. in 2020, water-air polishing with glycine-based powder is more effective than ultrasound and sodium bicarbonate treatment [12,13].

Our results show that the use of this method in patients with a mucosa prone to trauma does not cause complications and can be recommended by leading specialists in comprehensive oral hygiene. Taking into account the positive effect of glycine powder "softness" compared to sodium bicarbonate powder it is better for patients with dry mouth syndrome to carry out professional oral hygiene using gentle chemical compounds with minimal mechanical effect on soft tissues [14,15]. As shown by the study Arakelyan M.G. in 2017 [16] the subjective feelings of patients who used of xylitol-based spray with prolonged (30-40 min) moisturizing effect were significantly better than those of patients who used regular sorbitol-based spray. This statement is supported by other authors which confirmed the clinical effectiveness of both xylitol and betaine as an additive in xerostomia [17,18].

Conclusion

The clinical effectiveness of the moisturizing toothpaste with active components of Sodium PCA, betaine, mallow, xylitol in patients with drug-induced dryness of oral cavity during treatment of the underlying disease has been shown.