Correlation of Periodontal Status and Salivary Flow in Patients with Oral Submucous Fibrosis in Central India Population: A Study Protocol

Background: One of the commonest premalignant condition is Oral Submucous Fibrosis. The main etiology is consumption of areca nut and its products which leads to reduced mouth opening (Trismus) and reduction in the salivary flow (Xerostomia). Both these conditions eventually result in periodontal destruction. Objectives: The purpose of this research is to see if there is a link between periodontal health and salivary flow in OSMF patients. Methodology: 50 patients each clinically diagnosed as chronic periodontitis with and without OSMF will be enrolled in test and control group respectively. Plaque Index, Papillary Bleeding Index, Probing Pocket Depth, Clinical Attachment Loss (CAL), Gingival Recession (REC) will be compared in both the group for assessment of the result. Saliva that has not been stimulated will be collected using a funnel in a calibrated beaker in both the groups. Results: Patients with OSMF and chronic periodontitis will have reduced salivary flow and a compromised periodontal status whereas chronic periodontitis patients without OSMF will have normal salivary flow and comparatively less periodontal destruction. Study Protocol Kewalramani et al.; JPRI, 33(63B): 73-79, 2021; Article no.JPRI.80828 74 Conclusion: OSMF is precancerous condition which leads to xerostomia and may result in periodontal destruction and therefore OSMF condition should be identified and treated as early as possible.


INTRODUCTION
Human beings have been subjected to physical and mental stress as a result of the rapid rise of industry and urbanisation in the previous century. Humans use things like alcohol, cigarettes, areca nut and its derivatives to reduce stress, which have detrimental effects on the body. One of the degenerative illnesses caused by these practises is "oral submucous fibrosis" (OSMF) [1]. "OSMF is a chronic, progressive, scarring condition mainly affecting people of South-East Asian origin" [2].
In India, prevalence of OSMF is 0.2-2.3 percent and 1.2-4.6 percent in males and females respectively within the age range of 11 to 60 years [3]. The malignant transformation rate is estimated to be between 7 -13 percent [4]. Areca nut and its derivatives such as Guthka, betel quid, paan masala and others are the most prominent causes of OSMF. Nutritional deficiency and genetic predisposition are two other causes of OSMF [5,6]. Along with reduced mouth opening (trismus) and inability to eat, OSMF patients present with white fibrous bands, inability to whistle and blow candle, palatal ulceration and dryness of mouth. As the OSMF patients present with trismus and xerostomia, it would lead to compromised oral hygiene practices and reduced salivary flow respectively. These conditions together may act as a predisposing factor for plaque accumulation and further may result into compromised periodontal status of the patient.
Despite the fact that studies have indicated a link between decreased salivary flow and periodontal status in OSMF patients on their own, there has been no clinical examination of the association between periodontal condition and salivary flow in OSMF patients. Therefore, the current study is undertaken to look into the relationship between salivary flow and severity of periodontitis in individuals with and without OSMF in Central India.

Objectives
The goal of this study is to see if there is a link between salivary flow and severity of periodontitis in individuals with and without OSMF with following objectives:  Probing pocket depth (PPD) -"distance from the gingival margin to the base of the pocket".

4.
Clinical attachment loss (CAL) -"distance between cemento enamel junction and the base of the pocket" 5.
Gingival Recession (REC)-"distance between cemento enamel junction and gingival margin" Diagnosis of chronic periodontitis will be made following the classification given in American Academy of Periodontology 1999 [11]. "Chronic periodontitis is defined as common oral condition characterised by long-term inflammation of the periodontal tissues caused by the deposition of large amounts of dental plaque". It will be further categorised as: Groups will be as follows: I: "There is no evidence of a restriction in mouth opening, only symptoms are present." II: "There is limited mouth opening of 20 mm and above". III: "Mouth opening is less than 20 mm." IV: "OSMF has advanced and there is limited. Changes in the mucosa that are precancerous or cancerous." C) Non-stimulated salivary flow will be measured. The non-stimulated saliva will be collected in the following manner [13].
Materials used for collection will be Funnel and calibrated beaker.
Method will be as follows: One hour prior to the test, the patient will be asked to avoid eating or drinking anything (except water). During this time, smoking, chewing gum, and drinking tea will be prohibited. The patient will be instructed to use distilled water to rinse his or her mouth multiple times before relaxing for five minutes. Then patients will be asked to keep their mouth open in the funnel with their eyes open for 5 minutes. Beaker will be kept under the funnel and saliva will be collected in it. Readings will be noted down in a periodontal chart.

Statistical Analysis
Statistical analysis will be conducted using descriptive and inferential statistics, including the chi-square test, student paired and unpaired ttests, with SPSS version 24.0 and GraphPad Prism version 7.0.

EXPECTED RESULTS
This study will compare the periodontal status and salivary flow in total 100 patients with and without OSMF. All the clinical parameters (PI, PBI, PPD, CAL, GR) in the test group will be significantly higher as compared to control group.
Test group will show reduced amount of salivary flow and the periodontal status will be much more compromised in comparison to control group.
In test group, Group I will show very mild periodontal destruction, Group II will show mild periodontal destruction, Group III will show moderate periodontal destruction and Group IV will show severely compromised periodontal status.
In all the four groups salivary flow will be observed to be reduced gradually from Group I to Group IV leading to severe xerostomia in Group IV patients and hence compromised periodontal status.

DISCUSSION
Oral Submucous Fibrosis, also known as "Atropica idiopathica mucosae oris," is a potentially cancerous condition reported by Schwartz in 1952. Jens J Pindborg defines "OSMF as an insidious, chronic disease that affects any area of the oral cavity and occasionally the pharynx" [14]. Most of the patients visiting the outpatient department of Sharad Pawar Dental College and Hospital, Sawangi (Meghe), Wardha, Maharashtra are labourers and they have habit of chewing areca nut while working. Therefore, the prevalence of OSMF patients in this region is high. Also, these patients are unaware about the severity of the disease as well as maintenance of oral hygiene. OSMF is not only a pre-cancerous condition but also associated with compromised periodontal condition due to trismus and xerostomia that eventually results into early tooth loss at young age. Therefore, early diagnosis and management by motivating patient for cessation of habit and creating awareness for the maintenance of oral hygiene is a crucial part of dental professional in such a rural area of central India [33-40].

CONCLUSION
According to the findings of this study Periodontal health is affected in patients with OSMF. A definite link between reduced salivary flow and poor periodontal health status in OSMF patients will be observed.

CONSENT AND ETHICAL APPROVAL
Institutional Ethical Committee (DMIMS, DU) approval will be obtained before the study commences. Risk and consent form will be signed by each participant.