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Table of Contents
ORIGINAL ARTICLE
Year : 2020  |  Volume : 3  |  Issue : 1  |  Page : 8-16

Comparative evaluation of alteration in salivary pH among gutkha chewers with and without oral submucous fibrosis and healthy subjects: A prospective case-control study


1 Department of Oral and Maxillofacial Surgery, Chhattisgarh Dental College and Research Institute, Rajnandgaon, Chhattisgarh, India
2 Department of Oral Medicine and Radiology, Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Nagpur, Maharashtra, India
3 Department of Oral Medicine and Radiology, Guru Gobind Singh College of Dental Science and Research Centre, Burhanpur, Madhya Pradesh, India
4 Department of Oral and Maxillofacial Surgery, Sathyabama Dental College and Hospital, Chennai, Tamil Nadu, India
5 Department of Oral and Maxillofacial Surgery, Hitkarini Dental College and Hospital, Jabalpur, Madhya Pradesh, India
6 Department of Oral Pathology and Microbiology, Care Dental College and Hospital, Guntur, Andhra Pradesh, India
7 Department of Oral Medicine and Radiology, Saraswati Dhanwantari Dental College and Hospital and Post-graduate Research Institute, Parbhani, Maharashtra, India

Date of Submission03-May-2020
Date of Acceptance13-May-2020
Date of Web Publication08-Jul-2020

Correspondence Address:
Dr. Abhishek Singh Nayyar
Department of Oral Medicine and Radiology, Saraswati Dhanwantari Dental College and Hospital and Post-graduate Research Institute, Parbhani, Maharashtra,
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jco.jco_12_20

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  Abstract 

Context and Aim: Several studies have shown that during gutkha chewing, many harmful chemicals and metals are leached-out into the saliva altering salivary parameters including the flow rate and pH, whereas the normal range of salivary pH is recorded to be within 5.5–7.9 with the flow rate in a range of 0.33–1.42 mL/min. Due to a scarcity of literature on this aspect of the disease process of patients with oral submucous fibrosis (OSMF), this study intended to assess and compare the pH of saliva among gutkha chewers with and without OSMF and healthy subjects. Materials and Methods: This study was designed as a prospective case-control study comprising 90 individuals within an age range of 15–50 years who were divided into three groups with Group A consisting of 30 patients who were gutkha chewers with OSMF, Group B consisting of 30 individuals who were gutkha chewers but without OSMF, and Group C consisting of 30 healthy subjects who were included as normal controls. Salivary pH was measured using the pH indicator strips (INDIKROM PAPERS, pH: 3.5–6 and pH: 6.5–9). Statistical Analysis Used: The data were analyzed using Statistical Package for the Social Sciences (SPSS) version 16.0 (SPSS, Chicago, Illinois). Comparison of the said parameters was done using chi-square test, analysis of variance (ANOVA), and Tukey’s post hoc test. A value of P < 0.05 was considered statistically significant. Results: The results were not found to be statistically significant when the pH among OSMF (Group A) and individuals with habit but without OSMF (Group B) was compared, though, significant between Groups A and C. Conclusion: From the findings of this study, it could be concluded that “reduced salivary pH could be a significant initial subjective sign of OSMF.” An early diagnosis and management of these changes, thus, can not only help such patients to improve their quality of life (QoL) significantly but also can decrease the chances of the ongoing malignant transformation.

Keywords: Gutkha chewers, oral submucous fibrosis, prospective case-control study, salivary pH


How to cite this article:
Tamgadge P, Wasekar R, Kulkarni S, Chandran A, Jain S, Chalapathi K, Nayyar AS. Comparative evaluation of alteration in salivary pH among gutkha chewers with and without oral submucous fibrosis and healthy subjects: A prospective case-control study. J Curr Oncol 2020;3:8-16

How to cite this URL:
Tamgadge P, Wasekar R, Kulkarni S, Chandran A, Jain S, Chalapathi K, Nayyar AS. Comparative evaluation of alteration in salivary pH among gutkha chewers with and without oral submucous fibrosis and healthy subjects: A prospective case-control study. J Curr Oncol [serial online] 2020 [cited 2020 Aug 14];3:8-16. Available from: http://www.journalofcurrentoncology.org/text.asp?2020/3/1/8/289120




  Introduction Top


The world of medical science is replete with a plethora of conditions, both physiological and pathological, which show a multitude of symptoms, some of which humankind has managed, whereas others he is still waging a relentless war. Oral submucous fibrosis (OSMF) is an old enemy in this context which is gaining repeated mention in the oral health circles. OSMF has become a serious concern to the health-care providers as it largely affects the younger age groups. It is a debilitating condition in which the patients complains of intolerance to spicy food, rigidity in lip and tongue, difficulty in mouth opening and speech and swallowing, and has high chances of developing into malignancy, thereby reducing the quality of life (QoL), in other words, leading to increased morbidity as well as associated with a chance of mortality.[1] The prevalence of OSMF in India is estimated to be approximately 0.2%–0.5%, whereas the prevalence by gender varies from 0.2% to 2.3% in males and 1.2% to 4.57% in the females because of an increased prevalence of the habit of smokeless forms of tobacco usage in the females.[2],[3] The malignant transformation rate for OSMF varies from 2.3% to 7.6%.[4] To summarize, OSMF is a unique oral affliction that has infested the oral cavities of “betel nut” and “gutkha” chewers in a pandemic manner having high morbidity and mortality, even, in the first few decades of life.[5]

Betel nut chewing, the main cause for the causation of OSMF in India, has been reported as the fourth dependent substance among the substances of abuse followed by nicotine, alcohol, and caffeine.[6] It is directly linked to the oral cavity and saliva is the first biological fluid exposed to such products.[7],[8] During gutkha chewing, many harmful chemicals and metals are leached-out into the saliva.[9] Betel nut, the main ingredient of gutkha, contains alkaloid arecoline, which is a known genotoxic constituent whereas lime, another significant constituent of gutkha, causes intense local irritation of the mucosa. Another important ingredient of betel nut, catechu, contains an alkaloid, catechin, which when combined with lime, is known to produce heavy amounts of reactive oxygen species (ROS) which are, also, proven to be mutagenic.[10] Therefore, gutkha represents a convoluted mixture of adverse constituents which not only increases the chances of morbidity and mortality in the individuals but also alters the salivary parameters including the flow rate of saliva as well as the salivary pH. Several studies have documented the normal range of salivary pH to be within 5.5–7.9, whereas the normal salivary flow rate is in a range of 0.33–1.42 mL/min.[11] Due to a scarcity of the literature on this aspect of the disease process and the impact of gutkha chewing on the salivary parameters including the pH of saliva, this study intended to assess and compare the same among gutkha chewers with and without OSMF and healthy subjects.


  Materials and Methods Top


This study was designed as a prospective case-control study comprising 90 individuals within an age range of 15–50 years who had reported to the outpatient department (OPD) and were divided into three groups with Group A consisting of 30 patients who were gutkha chewers with OSMF, Group B consisting of 30 individuals who were gutkha chewers but without OSMF, and Group C consisting of 30 healthy subjects who were included as normal controls. The study was conducted for 18 months, whereas ethical clearance was obtained from the Institutional Ethics Committee before the start of the study. The subjects were informed in detail about the study and a written, informed consent was obtained from each participant before the start of the study after which the patients were examined thoroughly and a detailed case history was recorded in a specially designed proforma. The inclusion criteria included a positive history for gutkha chewing habit of more than 6 months duration and with clinically diagnosed OSMF in case of Group A, whereas a positive history for gutkha chewing habit of 6 months or more duration but with no clinical evidence of OSMF in case of Group B. The individuals with gutkha chewing habits of less than 6 months duration and with no clinical evidence of OSMF were, also, included in Group B, whereas Group C consisted of 30 healthy subjects who were not positive for a history of habit and were included as the normal controls. Individuals with habits such as smoking and/or alcohol consumption, patients with any known systemic disorders, pregnant and lactating females, and patients who had received any type of treatment for OSMF or frank malignancies were excluded from the study. The demographic details, habit history, if found positive, and clinical parameters were recorded in the predetermined proforma after a thorough clinical examination in day light [Figure 1][Figure 2][Figure 3][Figure 4].
Figure 1: Armamentarium for clinical examination

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Figure 2: pH indicator strip for pH determination

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Figure 3: (A) Blanching seen in right buccal mucosa in a patient. (B) Blanching seen in left buccal mucosa. (C) Blanching seen in relation to lower labial mucosa. (D) Blanching seen in relation to soft palate with shrunken uvula. (E) Maximal mouth opening in patient. (F) Tongue protrusion test

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Figure 4: Estimation of salivary pH

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Determination of pH

The procedure was explained to the patients, whereas the patients were advised to refrain from intake of any food and/or beverage (water exempted) 1h before the test session, whereas the procedure was performed between 9:00 AM and 12:00 PM to avoid diurnal variations, if any, and their subsequent impact on salivary pH. The subjects were advised to rinse their oral cavity with water and then asked to relax for 5 min. Then, patients were asked to swallow the whole saliva from the mouth and after that no movement was allowed to be made before and during the collection of salivary samples. Salivary pH was measured using the pH indicator strips (INDIKROM PAPERS, pH: 3.5–6 and pH: 6.5–9) [Figure 2], [Figure 4]. The pH strip was placed in the floor of mouth near the submandibular duct. The change in color of the strip was noted and matched with the color coding provided on the index guidelines.[9]

Statistical analysis used

The data were analyzed using Statistical Package for the Social Sciences (SPSS) version 16.0 (SPSS, Chicago, Illinois). Comparison of the said parameters was done using chi-square test, analysis of variance (ANOVA), and Tukey’s post hoc test. A value of P < 0.05 was considered statistically significant.


  Results Top


[Table 1] provides the demographic profile of patients among patients with OSMF, patients with betel nut/gutkha chewing habit without OSMF and control group, wherein 9 (30.0%) patients from Group A, 7 (23.3%) patients from Group B, and 13 (43.3%) individuals from Group C were found to be in the age range of 15–25 years, whereas 10 (33.3%) patients from Group A, 13 (43.3%) from Group B, and 15 (50%) from Group C were in the age range of 26–35 years. Also, 11 (36.7%) patients from Group A, 10 (33.3%) patients from Group B, and 2 (6.7%) from Group C were in the age range of 36–45 years. The mean age in Group A was found to be 30.96 (±7.51) years, in Group B it was 32.2 (±7.12) years, whereas in Group C it was 27.5 (±6.05) years. There was no statistically significant difference between three groups with respect to age distribution (P > 0.05).
Table 1: Demographic profile of patients among patients with OSMF, patients with betel nut/gutkha chewing habit without OSMF, and control group

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Also, the total number of male patients in Group A were found to be 28 (93.3%), 22 (73.3%) in Group B, and 21 (70%) in Group C. The total number of females, 2 (6.7%) in Group A, 8 (26.7%) in Group B, and 9 (30%) in Group C, was found to be lower than the total number of males in this study, although this difference was found to be statistically insignificant (P > 0.05) [Table 1].

Furthermore, 3 (10%) patients from Group A were having habit of chewing betel nut, 23 (76.7%) patients were having habit of chewing gutkha, and 4 (13.3%) patients were having habit of both chewing betel nut and gutkha chewing habit. In Group B, 10 (33.3%) patients were having habit of chewing betel nut, 19 (63.3%) had gutkha chewing habit, and 1 (3.3%) showed habit of chewing both betel nut and gutkha. As Group C was the control group, none of the individuals included had any type of habit and the difference, in this case, was found to be statistically significant (P = <0.01) [Table 1].

[Table 2] shows the distribution of stages of OSMF in Group A, wherein of 30 patients with OSMF, 8 (26.7%) were in stage I, 12 (40%) were in stage II, whereas 10 (33.3%) were found to be in stage III.
Table 2: Distribution of patients according to stages of OSMF in group A

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[Table 3] shows distribution of the habit among all the three groups according to the frequency, exposure, and duration of the habit wherein it was observed that 6 (20.0%) patients from Group A were having a frequency for consumption of the said products 1–3 times a day, 16 (53.3%) showed a frequency of 4–5 times per day consumption, 5 (16.7%) showed a frequency of 6–7 times per day consumption, whereas 3 (10%) patients showed a frequency of more than 8 times per day consumption of betel nut or, gutkha or, both. In Group B, 22 (73.3%) patients showed a frequency for habit of 1–3 times per day, 2 (6.7%) patients showed a frequency of 4–5 times per day, 5 (16.7%) showed a frequency of 6–7 times per day, whereas only 1 (3.3%) patient showed a frequency of more than 8 times per day consumption of the deleterious products and this difference between distribution of the frequency among all the three groups, too, was found to be statistically significant (P = < 0.01) in this study. In relation to exposure, the findings of this study suggested 3 (10%) patients in Group B having an exposure time for habit consumption of 2–5 min, whereas 3 (10.3%) patients from Group A and 13 (43.3%) patients from Group B showed an exposure time for habit consumption of 5–10 min. As against these patients, 26 (89.7%) patients from Group A and 14 (46.7%) from Group B showed an exposure time of more than 11 min and the difference was found to be statistically significant (P = 0.002). In Group B, 2 patients had habit of less than 1 year duration, 2 (6.7%) patients in Group A, and 6 (20.0%) patients in Group B had habit of 1–3 years duration, 2 (6.7%) patients from Group A and 3 (10%) patients from Group B were having habit of approximately 3–5 years duration, whereas 26 (86.7%) patients from Group A and 19 (63.3%) patients from Group B were having habit of more than 5 years duration; however, this difference was not found to be statistically significant (P = 0.15) in this study.
Table 3: Comparison of Group A and Group B with frequency, exposure, and duration of habit

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[Table 4] shows the comparison of mean salivary pH among the three groups. The mean salivary pH among patients with OSMF (Group A) was found to be 6.3103 (±0.61838), in Group B; similar values were found to be 6.6500 (±0.58942) and in Group C, the mean salivary pH was found to be 6.8000 (±0.48423) and this difference, too, was found to be statistically significant (P = 0.004) in this study. The pair-wise comparison by Tukey’s post hoc test showed that the pH among Group A patients was found to be equal to the pH observed among Group B patients, whereas pH among Group A patients was lesser than the pH among Group C normal healthy subjects. Also, pH among Group B patients and Group C normal healthy controls was found to be the same, and thus the results were not found to be statistically significant when the pH among OSMF (Group A) and individuals with habit but without OSMF (Group B) was compared, though, significant between Groups A and C.
Table 4: Comparison of mean pH scores in the three groups (A, B, C) by one way ANOVA

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[Table 5] provides the comparison of mean salivary pH among the various stages of OSMF wherein the mean salivary pH among patients with OSMF stage I was found to be 6.7500 (±0.46291), among stage II it was found to be 6.1818 (±0.60302), and among patients with OSMF stage III, the mean salivary pH was found to be 6.1000 (±0.61464), although this difference was statistically insignificant. The pair-wise comparison by Tukey’s post hoc test showed that there was no significant difference observed in the pH among the various stages of OSMF (P = 0.05).
Table 5: Comparison of mean pH scores amongst various stages of OSMF by one way ANOVA

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[Table 6] shows the comparison of the mean salivary pH by one-way ANOVA among the participants with various types of habits wherein the mean salivary pH among the patients without any habit was found to be 6.8000 (±0.48423), among patients with betel nut chewing habit it was found to be 6.8077 (±0.56045), among patients with gutkha chewing habit it was found to be 6.3659 (±0.61262), whereas 6.6000 (±0.65192) among the patients having both betel nut and gutkha chewing habit this difference was found to be statistically significant (P = 0.009) in this study. The pair-wise comparison by Tukey’s post hoc test showed that the pH among the patients with habit of gutkha chewing had significantly less pH as compared to the patients having habit of betel nut chewing and patients with habit of both betel nut and gutkha chewing habit.
Table 6: Comparison of mean pH scores amongst participants with various types of habits by one way ANOVA

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  Discussion Top


OSMF is indeed one of the classic “Diseases of Civilization,” now, globally accepted as the disease that belongs to the Indian subcontinent which has one of the highest rate of malignant transformation among the various oral potentially malignant epithelial lesions (PMELs).[12] A malignant transformation rate of 7.6% over a period of 10 years is reported for OSMF and the relative risk for malignant transformation may be as high as 11.7%.[13] The condition is characterized by burning sensation and depigmentation of oral mucosa along with reduced movement and depapillation of tongue and progressive reduction of mouth opening.[14] Some patients may, also, have excessive salivation, probably, due to their inability to swallow the normal amount of saliva as a result of reduced tongue movement. Apart from this, some studies have, also, documented dryness of the mouth due to xerostomia and altered taste perception due to xerostomia and atrophy of the papilla. There have been few studies that have been conducted on the assessment of the pH of saliva among patients with OSMF and individuals having the habit of betel nut or, gutkha chewing but those who have not developed the same. This study was planned with a similar intent to assess and compare the alteration in the pH of saliva among Gutkha chewers with and without OSMF and healthy subjects.

The mean age among patients with OSMF in this study was found to be 30.96 years similar to the findings in the existing literature wherein a peak incidence of OSMF has been reported to be in the third decade of life which might be due to more social exposure at this age and relative ease in the availability of such products at this age without any hindrance. This observation in this study was found to be in accordance with the studies conducted by Wahi et al.,[15] Sinor et al.,[16] and Reddy et al.,[17] who, also, observed the peak incidence of the disease in the third decade of life in their studies. Noor-ul-Wahab et al.,[18] though, found the maximum number of patients (73%) to be in their second decade of life in their study followed by the third decade wherein the second peak was noted.

Similarly, there have been varying reports on sex ratio in different published studies. In this study, in the OSMF group, 28 (93.3%) of the patients were males, whereas only 2 (6.7%) were female patients. A definite male predominance observed in this study with a male:female ratio of 14:1 was found to be similar to the findings reported by the studies conducted by Wahi et al.,[15] Shah and Sharma,[19] and Ranganathan et al.[20] Another study conducted by Reddy et al.,[17] also, showed that of the 390 patients of OSMF included in their study, 70.26% of the patients were males, whereas only 29.74% were of the patients were females, thereby showing a definite male predominance for the disease process. Contrary to the findings of the said study, Rao,[21] though, reported 29 females and 17 males among the 46 patients with OSMF included in their study, thereby showing a female predominance. According to Rajendran et al.,[22] a female predominance seen with the said disease process might be related to factors such as the more common usage of the smokeless forms of tobacco including betel nut and a relative deficiency of iron, vitamins, and many other nutritional factors in the females as prevalent in the Indian subcontinent.

In this study, of the 30 patients with OSMF included, 12 (40%) patients were having stage II OSMF which was higher as compared to the ratio of patients having stage I and stage III OSMF in contrast to the study conducted by Nigam et al.[23] who observed maximum number of patients in their study to be in stage I OSMF followed by stage II and stage III, respectively. Reddy et al.,[17] though, found more number of patients in stage II in their study similar to the findings of this study with stage I OSMF seen with 197 (50.51%) patients, stage II OSMF found with 110 (28.20%) patients, whereas stage III OSMF with 83 (21.28%) patients.

Different hypotheses, put forth, suggest that OSMF is a multifactorial disease process with areca nut chewing being the major etiological factor behind the causation of OSMF as suggested in the various epidemiological and in vitro experimental studies conducted so far, although there might be seen regional variations in the different parts of the subcontinent depending on the various forms and concentrations and additives used with this form of smokeless, areca nut chewing habit. Areca or betel nut is the inner kernel or seed which is obtained after removing husk of areca nut and gutkha is a mixture of areca nut, tobacco, slaked lime, catechu, and numerous other spices, which was introduced in the Indian market in 1980s.[24] In this study, of the 30 patients included with OSMF, patients having habit of gutkha chewing (76.7%) showed a significant increase in incidence of OSMF as compared to the patients having habit of betel nut chewing (10.0%), and both betel nut and gutkha chewing (13.3%) habit which was in accordance with the findings of the study conducted by Sharma et al.[25] who reported that among the 231 OSMF patients included in the study, 135 (58.44%) patients had habit of gutkha chewing, whereas 52 (22.51%) had a habit of areca nut and tobacco and 44 (19.04%) patients had areca nut chewing habit. Contrary to these findings, the study conducted by Reddy et al.[17] showed areca nut to be the main etiologic factor followed by gutkha and other areca nut products such as tobacco and mawa in the causation of OSMF.

This study, also, revealed that increase in the frequency and exposure of the habit significantly increased the incidence of OSMF, thereby highlighting a dose–dependence relationship between areca nut and OSMF as has been confirmed in the published literature, though the study did not find a significant association of OSMF with the duration of the habit. However, it did not show a significant relation with habit duration as against the finding of the study conducted by Reddy et al.,[17] which showed that increase in habit frequency, duration, and exposure were all the primary etiological factors deciding the causation of OSMF. Another similar study conducted by Sinor et al.,[16] also, showed that the relative risk of OSMF gets increased with the duration as well as the frequency of areca nut chewing with yet another study highlighting the dose–dependence relationship between areca nut and the causation of OSMF. On similar grounds, another study conducted by Maher et al.[26] reported that the frequency of areca nut chewing was more important than duration of the habit in the causation of OSMF, whereas yet another study conducted by Khader and Dyasanoor[9] found duration of the habit to be more important than frequency and exposure. In contrast to these studies, Pindborg et al.[27] reported 31.8% of the patients of the 63 patients of OSMF included in their study not to have any positive history of any habit, be it in the smoked or smokeless forms of the tobacco or areca and betel nut chewing habit.

Saliva is an important body fluid as it is essential in maintaining oral health. It plays an important role in lubrication of the oral mucosal tissues, remineralization of the initial demineralization defects of the dental hard tissues, pH balance as well as facilitation of the processes leading to mastication and deglutition and digestion of the ingested food. As it modulates the ecosystem, it plays an important role in maintaining oral homeostasis. Saliva is the most easily accessible fluid in the human body. During betel nut chewing, the physicochemical composition as well as the properties of saliva get altered as many chemicals and metals leach-out into the saliva during ingestion of such products. In literature, alteration in salivary flow rate and salivary pH has been reported in individuals with the habit of areca or betel nut chewing. In this study, pH was evaluated by using pH indicator strips similar to the methodology adopted in the study conducted by Rooban et al.[28] The studies conducted by Katie et al.[11] and Franco et al.,[29] though, used a pH meter to evaluate the salivary pH.

In this study, the mean pH among the control group was found to be 6.8000 in accordance with a range of 6.2–7.6 with 6.7 being the average pH of saliva in the study conducted by Baliga et al.[30] Rooban et al.[28] and Barman and Umesh,[31] though, reported a long range of normal salivary pH from 5.5–7.9. In this study, the mean pH among OSMF patients was found to be 6.3103, among individuals with the habit of betel nut/gutkha chewing but without OSMF, it was found to be 6.6500, whereas among the healthy controls, it was found to be 6.8000 and the results were found to be statistically significant which was in accordance with the study conducted by Rooban et al.[28] Grover et al.,[32] also, found lower (acidic) pH among tobacco users as compared to the controls in their study.

Similar results were obtained in another study conducted by Singh et al.,[33] who also observed a decreased pH in subjects having a positive history of habit in the form of smoked tobacco than the smokeless forms. Likewise, on similar grounds, an experimental study conducted by Chakrabarty et al.[34] revealed that the long-term use of tobacco, both in the smoked and smokeless forms, adversely affects the salivary reflexes and pH and stated that the smoked form of tobacco was more harmful than the smokeless forms as far as the salivary changes are concerned. The mean salivary pH among patients with OSMF and individuals with betel nut/gutkha chewing habit but without OSMF was found to be lower in yet another study conducted by Khan et al.[35] who found a lower pH in patients with habit with or without OSMF than the controls which was explained on the basis of the secretion of sodium ions into the saliva, thereby making it more serious.

In contrast to the findings of the said studies, Khader and Dyasanoor [9] and Siddabasappa et al.[36] found no statistically significant difference in the pH of chewers and nonchewers. Similarly, Khan et al.,[37] also, stated that the salivary parameters are not significantly affected by the long-term use of tobacco. No significant difference was found in the mean pH among the patients in the various stages of OSMF in this study, whereas this aspect of this study could not be compared because of a relative lack of literature in this regard. To conclude, the results obtained in this study were found to be encouraging as it was shown that the pH of saliva varied significantly among the patients with OSMF as against those having habit of betel nut/gutkha chewing but those who did not develop OSMF and the normal healthy controls and these data, though, initial, might be used on a scientific basis to improve the QoL in the affected patients as well as to prevent the further progression of the disease process.


  Conclusion Top


From the findings of this study, the following observations were drawn that when patient’s age and sex attributes were considered among the patients with OSMF, the highest incidence of the disease process was observed in the third decade of life with a definite predilection for the males. A definitive association was, also, found between the frequency and duration of exposure of the habit and the subsequent incidence of OSMF in such individuals. Again, pH among the habit positive individuals was found to be significantly low as against the healthy subjects. Thus, from the findings of this study, it could be concluded that “reduced salivary pH could be a significant initial subjective sign of OSMF.” An early diagnosis and management of these changes with the help of pharmacotherapy, physiotherapy, and a proper, balanced diet by the concerned oral physicians, thus, can not only help such patients to improve their QoL significantly but also can decrease the chances of the ongoing malignant transformation with early intervention and stoppage of habit.

Limitations of this study

The major limitation of this study was seen in the form of salivary pH values among the various stages of OSMF which were found to be statistically insignificant. The reason for this might be the smaller sample size included in the study which mandates further studies to be conducted in this regard to come to valid conclusions. Furthermore, the clinical parameters used in this study in the form of the pH of saliva were indicators of morbidity and a decreased QoL in the individuals having habit of betel nut/gutkha chewing, but these cannot be used as the relevant markers for the impending OSMF in such patients. A need for further research in this regard, thus, is highly desirable wherein the clinical data can be used to provide a scientific evidence to control or halt the process of malignant transformation in such patients who are with or without this deadly, potentially malignant condition, OSMF, because the risk of malignant transformation never ends there.

Future research directions

This study was designed as a prospective case-control study comprising 90 individuals within an age range of 15–50 years who were divided into three groups with Group A consisting of 30 patients who were gutkha chewers with OSMF, Group B consisting of 30 individuals who were gutkha chewers but without OSMF, and Group C consisting of 30 healthy subjects who were included as normal controls, whereas salivary pH was measured using the pH indicator strips (INDIKROM PAPERS, pH: 3.5–6 and pH: 6.5–9). The study design was basically an observational one, whereas further study can be conducted with the observation of the changes in pH with tobacco cessation in a longitudinal study design. Salivary pH, if proven as a marker of such changes leading to progression and/or regression of the said disease process or ongoing malignant transformation, can, then, help to stop the further progression of the disease improving QoL significantly in such patients in addition to decreasing the chances of the ongoing malignant transformation with early intervention.

Acknowledgement

We would like to thank all the patients who contributed in the study. This study would not have been possible without them.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]



 

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