CLINICAL EVALUATION OF A PLANT BASED BIOLOGICAL FILM FOR THE TREATMENT OF DENTURE STOMATITIS IN WEARERS OF REMOVABLE ACRYLIC DENTURES

ISSN: 2582-4686 SJIF 2021-3.261,SJIF 20222.889, 2024-6.875 ResearchBib IF: 9.948 / 2024 VOLUME-5, ISSUE-11 1101 CLINICAL EVALUATION OF A PLANT-BASED BIOLOGICAL FILM FOR THE TREATMENT OF DENTURE STOMATITIS IN WEARERS OF REMOVABLE ACRYLIC DENTURES Mirkhoshimova Muyassar Tashkent State Medical University https://orcid.org/0009-0008-2633-446X e-mail: [email protected] Abstract Background. Removable acrylic dentures remain one of the most widely used methods of prosthetic rehabilitation in patients with partial or complete edentulism because they are relatively simple to fabricate, affordable, and capable of restoring chewing efficiency and aesthetics. However, long-term denture use is frequently associated with pathological changes in the denture-bearing tissues, most notably denture stomatitis, which according to different authors affects more than half of all wearers of removable dentures. The aetiology of this condition is multifactorial and includes mechanical trauma, microbial biofilm formation, Candida colonisation, and the presence of residual methyl methacrylate monomer in acrylic base materials. Aim. To evaluate the condition of the denture-bearing mucosa in wearers of removable acrylic dentures and to compare the clinical efficacy, tolerability, and socio-economic benefits of a plant-based biological film with those of a conventional Parodium® gel in the treatment of denture stomatitis using quantitative light-fluorescence diagnostics. Materials and methods. A total of 80 patients with clinically diagnosed denture stomatitis related to removable acrylic dentures were examined. The severity and extent of mucosal inflammation were assessed with the AIO BIO Qscan Plus device, which is based on quantitative light fluorescence and bioimpedance analysis. For comparative clinical evaluation, two main treatment groups were formed: Group 1 received the plant-based biological film applied to the affected mucosa, while Group 2 received standard care with Parodium gel. In both groups, local treatment was combined with correction of prosthetic bases where needed and reinforcement of denture-hygiene instructions. Patients were followed for 7 days with dynamic clinical and instrumental monitoring. Results. Use of the plant-based biological film led to more rapid reduction in pain, a faster decrease in the area of inflamed mucosa, and earlier complete epithelialisation of the denture-bearing tissues compared with Parodium gel. No adverse reactions were recorded in either group. Patient satisfaction was higher in the biological-film group (92% ‘very satisfied’) than in the Parodium group (78% ‘satisfied’). The accelerated resolution of inflammation allowed a reduction of direct outpatient treatment costs by approximately 45,000 Uzbek sum per patient and saved up to 20 person-days of working capacity per 100 treated patients. Conclusions. The plant-based biological film is an effective and well-tolerated local agent for the treatment of denture stomatitis in wearers of removable acrylic dentures. Its use in routine prosthodontic practice improves clinical outcomes, enhances patient quality of life, and provides measurable socio-economic advantages compared with conventional gel therapy. ISSN: 2582-4686 SJIF 2021-3.261,SJIF 20222.889, 2024-6.875 ResearchBib IF: 9.948 / 2024 VOLUME-5, ISSUE-11 1102 Keywords: denture stomatitis; removable acrylic dentures; denture-bearing mucosa; plant-based biological film; Parodium gel; quantitative light fluorescence; AIO BIO Qscan Plus. Introduction Prosthodontics is one of the most dynamically developing branches of dentistry. Its primary task is to restore lost teeth and to normalise the functional state of the stomatognathic system in patients with partial or complete edentulism. Removable acrylic dentures remain highly relevant in clinical practice due to their relative simplicity of fabrication, accessibility for socially vulnerable patient groups, and adequate functional and aesthetic outcomes. At the same time, numerous clinical studies and everyday practice show that long-term wear of removable dentures is often accompanied by adverse changes in the tissues of the denture-bearing area. One of the most frequent complications is denture stomatitis, characterised by diffuse or focal erythema, oedema, burning, and discomfort in the mucosa covered by the denture base. Various epidemiological data indicate that the prevalence of this condition ranges from 30 to 70% among denture wearers, depending on the population studied and diagnostic criteria. The aetiology of denture stomatitis is multifactorial. Local mechanical trauma from an ill-fitting denture, accumulation of microbial biofilm and Candida species on the denture surface, insufficient oral and denture hygiene, systemic diseases, and toxic effects of residual methyl methacrylate monomer in acrylic bases all play a role. Incomplete polymerisation of cold-cured resins, violations of the manufacturer’s technical protocol, or accelerated laboratory procedures may increase the residual monomer content and thereby intensify mucosal irritation. These factors are particularly important in elderly patients and individuals with reduced adaptive capacity of the oral mucosa. Conventional treatment approaches for denture stomatitis include temporary discontinuation of denture wear, correction, relining or remaking of the prosthesis, prescription of antiseptic and antifungal agents, the use of hypoallergenic or thermoplastic base materials, and active patient education in denture-hygiene procedures. Despite the wide range of available topical medications, clinical practice demonstrates the need for agents tha t simultaneously provide a pronounced anti-inflammatory and reparative effect, form a protective barrier on the mucosal surface, and are suitable for prolonged use without significant adverse reactions. In recent years, plant-based biological films containing bioactive extracts and polymer carriers have been proposed as promising topical agents. Such films adhere to the inflamed mucosa, gradually release therapeutic components, reduce microbial contamination, and promote epithelial regeneration. However, clinical data on their comparative effectiveness versus widely used gels, including Parodium, remain limited. Another important methodological aspect is the use of objective diagnostic tools to quantify mucosal changes. Devices based on quantitative light fluorescence, such as the AIO BIO Qscan Plus, allow the non-invasive visualisation of inflammatory and dysplastic lesions and make it possible to monitor the dynamics of tissue response during treatment. In this context, a comprehensive clinical and instrumental evaluation of a plant-based biological film for the treatment of denture stomatitis is of both scientific and practical interest. Materials and Methods Study design and participants ISSN: 2582-4686 SJIF 2021-3.261,SJIF 20222.889, 2024-6.875 ResearchBib IF: 9.948 / 2024 VOLUME-5, ISSUE-11 1103 The present prospective clinical study included 80 patients with denture stomatitis associated with the use of removable acrylic dentures. All participants were treated at dental clinics affiliated with the International University of Kimyo in Tashkent. The study protocol complied with the principles of the Declaration of Helsinki and was approved by the local ethics committee. Informed consent was obtained from all patients prior to inclusion. Inclusion criteria were the presence of a removable acrylic denture worn for at least three months, clinical signs of denture stomatitis in the mucosa of the denture-bearing area, and the patient’s ability to comply with follow-up visits. Patients with acute systemic diseases, severe immunodeficiency, a history of hypersensitivity to the components of the tested products, or recent use of systemic antibiotics or antifungals were excluded. Clinical assessment The severity of denture stomatitis was assessed clinically using standard criteria, including the extent and intensity of erythema, oedema, and subjective symptoms (burning, pain, discomfort). Pain intensity was recorded using a visual analogue scale. For instrumental assessment, the AIO BIO Qscan Plus device was employed. This system is based on quantitative light fluorescence and bioimpedance analysis and enables detection of pathological changes in the oral mucosa, including inflammatory and initial dysplastic lesions, under excitation by specific wavelengths of light. The device generates a fluorescence map of the examined mucosal area, and specialised software calculates the proportion of tissue exhibiting pathological fluorescence patterns. This percentage was used as an objective parameter of the area and activity of mucosal involvement. Examinations were performed at baseline and on days 3, 5, and 7 of treatment. Intervention For comparative purposes, two main treatment groups were formed. In Group 1, a plant-based biological film was applied to the affected areas of the denture-bearing mucosa once or twice daily according to the manufacturer’s instructions. The film contained a polymer carrier with plant extracts possessing anti-inflammatory and reparative properties and was designed to form a thin protective layer on the mucosal surface. In Group 2, patients received topical treatment with Parodium gel, which is widely used in dental practice for inflammatory conditions of the gingiva and oral mucosa. The gel was applied to the affected areas with comparable frequency. In both groups, where indicated, the denture bases were adjusted or relined to eliminate traumatic factors, and all patients received detailed instructions on oral and denture hygiene. Systemic pharmacotherapy was not used unless required for concomitant diseases. Outcome measures The primary outcomes were the reduction in pain intensity and the decrease in the area of inflamed mucosa as measured by quantitative light fluorescence. Secondary outcomes included the time to complete epithelialisation of the denture-bearing tissues, the incidence of adverse effects, and patient-reported satisfaction with treatment. Patient satisfaction was graded using a simple verbal scale (‘very satisfied’, ‘satisfied’, ‘not satisfied’). Descriptive statistics were used to summarise the clinical and instrumental data. Results Clinical dynamics ISSN: 2582-4686 SJIF 2021-3.261,SJIF 20222.889, 2024-6.875 ResearchBib IF: 9.948 / 2024 VOLUME-5, ISSUE-11 1104 Both treatment regimens resulted in improvement of clinical symptoms of denture stomatitis over the seven-day observation period. However, the rate and extent of improvement were greater in the group treated with the plant-based biological film. By day 3, patients in Group 1 demonstrated a marked reduction in burning and pain sensations in the denture-bearing area, whereas the decrease in subjective complaints in Group 2 was less pronounced. Instrumental examination with the AIO BIO Qscan Plus confirmed a faster reduction of the fluorescent-positive mucosal area in the biological-film group. On day 5, most patients in Group 1 presented only mild residual erythema without significant oedema. The fluorescence maps indicated a substantial reduction in the proportion of inflamed mucosa, which correlated with the clinical picture. In contrast, a considerable number of patients in Group 2 still exhibited areas of active inflammation according to both clinical examination and quantitative light fluorescence data. By day 7, complete epithelialisation of the denture-bearing mucosa was achieved in the majority of patients treated with the plant-based film, while in the Parodium group the healing process was often still incomplete, with residual erythema or persistent focal lesions. Adverse effects and patient satisfaction No significant adverse reactions were recorded in either treatment group. The plant-based biological film was well tolerated; patients did not report discomfort associated with its application or retention on the mucosal surface. Importantly, the film did not interfere with denture wear when used as recommended. Patient-reported satisfaction with the treatment outcomes was higher in Group 1: 92% of patients rated the results as ‘very satisfactory’, whereas in Group 2 this level of satisfaction was observed in 78% of cases, with some patients noting slower relief of symptoms and a need for repeated courses of gel application. Overall, the combination of clinical observations and quantitative light-fluorescence data indicates that the plant-based biological film provides a faster and more stable therapeutic effect compared with Parodium gel in the management of denture stomatitis. Social and Economic Effectiveness The accelerated resolution of inflammatory changes in the denture-bearing mucosa has important social and economic implications. Rapid relief of pain and discomfort improves the quality of life of patients, especially older individuals for whom removable dentures are often the only available method of prosthetic rehabilitation. Earlier restoration of normal masticatory function enables patients to maintain adequate nutrition and reduces the risk of gastrointestinal and systemic complications associated with prolonged oral dysfunction. From the standpoint of direct medical costs, the use of the plant-based biological film in the treatment of denture stomatitis reduced the duration of active local therapy and the need for additional visits. According to the economic estimates, outpatient treatment expenses decreased by approximately 45,000 Uzbek sum per patient compared with traditional management with Parodium gel. Furthermore, the faster recovery of the oral mucosa allowed patients to return to full social and professional activity earlier. It is estimated that for every 100 patients treated with the biological film, up to 20 person-days of working capacity were preserved. Thus, the introduction of the plant-based biological film into routine practice is justified not only by ISSN: 2582-4686 SJIF 2021-3.261,SJIF 20222.889, 2024-6.875 ResearchBib IF: 9.948 / 2024 VOLUME-5, ISSUE-11 1105 clinical advantages but also by its positive socio-economic impact for both patients and the health-care system. Conclusions The data obtained in this clinical and instrumental study demonstrate that a plant-based biological film is an effective and well-tolerated agent for the treatment of denture stomatitis in wearers of removable acrylic dentures. Compared with Parodium gel, the biological film provides faster relief of subjective symptoms, a more pronounced reduction in the area of inflamed mucosa as confirmed by quantitative light fluorescence, and earlier complete epithelialisation of the denture-bearing tissues. The absence of significant adverse reactions and the high proportion of ‘very satisfied’ patients support the feasibility of wide clinical use of this topical formulation. In addition, the reduction in direct treatment costs and the preservation of patients’ working capacity highlight the socio-economic benefits of the biological film. Further research with larger samples and longer follow-up periods will help to refine indications for its use, optimise treatment protocols, and evaluate long-term preventive effects on recurrent denture stomatitis. Nevertheless, the results of the present study indicate that incorporating the plant-based biological film into comprehensive prosthodontic care can contribute to improving the functional outcomes and quality of life of patients requiring removable acrylic dentures. REFERENCES 1. Budtz-Jørgensen E., Lombardi T. Denture stomatitis revisited. Periodontology 2000. 2018;78(1):254–261. 2. Felton D.A. 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