Effects of Nonsurgical Periodontal Therapy on Glycemic Control in Diabetic Patients under Systemic Administration of Antidiabetic Ayurvedic Drug

INTRODUCTION

Periodontitis is a chronic inflammatory disease caused by pathogens in the surrounding periodontal tissues, that results in the periodontal pocket formation, clinical attachment loss, and alveolar bone resorption, and ultimately leads to tooth loss.¹ While it is the bacterial infection that triggers the destructive process, it is the presence of risk factors and the host’s immune response to the bacterial challenge that is responsible for the molecular processes leading to periodontal tissue destruction.²

Diabetes mellitus (DM) and chronic periodontitis (CP) are chronic diseases that have long been considered to be biologically linked. In fact, diabetes is one of the primary risk factors for periodontitis.^3,4 Diabetes mellitus is a clinically and genetically heterogeneous group of metabolic disorders manifested by abnormally high levels of glucose in the blood. Periodontitis is one of the complications of diabetes. There is strong evidence that diabetes is a risk factor for gingivitis and periodontitis, and the level of glycemic control appears to be an important determinant in this relationship.^5,6 Patients with diabetes mellitus who have poor glycemic control are more likely to develop severe periodontitis and are at higher risk for the advancement of periodontal disease over time.^7,8 Diabetes results in changes in the function of immune cells, including neutrophils, monocytes, and macrophages. Neutrophil adherence, chemotaxis, and phagocytosis are often impaired; enabling bacteria to persist in the periodontal pocket and to significantly increase periodontal destruction.⁹

Evidence supports the concept that periodontal diseases can contribute to poorer glycemic control in people with diabetes and that treating periodontal infections could have a beneficial effect on glycemic control in either type-1 or type-2 DM.¹⁰ Studies have proved that nonsurgical periodontal treatment in type-2 diabetic patients is effective in improving metabolic control.¹¹ Periodontal nonsurgical treatment is important in periodontal patients affected by diabetes because, in addition to the negligible side effects, it leads to the reduction of one potential factor impairing glycemic control, while preserving dental and periodontal health.

Management of diabetes without any side effects is still a challenge in the medical field, as presently available drugs for diabetes have one or more adverse effects. In view of these adverse effects and limitations of intensive treatment of hyperglycemia in preventing diabetic complications, which is linked to oxidative stress, it has been proposed that simultaneous targeting of hyperglycemia and oxidative stress could be more effective than intensive treatment of hyperglycemia alone in the management of DM.

Due to their efficiency, lack of negative side effects and affordable price, herbal medications are frequently given. India has a long history of treating diabetes with a variety of strong herbs and herbal remedies. Nishamalaki (NA) drug is a unique ayurvedic formulation comprising of two herbal products turmeric and gooseberry.¹² Nishamalaki is offered as tablets and powder. The medication is made by combining an equal amount of dried turmeric rhizome powder with dried gooseberry fruit powder (Amla). Gooseberry interferes with the absorption of glucose and delays glucose entry in the blood, thereby preventing sudden spikes in glucose levels in the blood. Turmeric improves the functions of β-cells of pancreas. Nishamalaki can be used with any allopathic medication because it contains kitchen ingredients. It is recommended to keep a minimum 3-hour separation between NA and any allopathic or homeopathic medications for safety reasons.

However, till date, only limited clinical trials exist to assess the effect of nonsurgical periodontal therapy on periodontal and glycemic status in type-2 DM patients with chronic periodontitis under ayurvedic treatment.

Thus, in this study, an attempt was made to assess the effectiveness of scaling and root planing on the glycemic and periodontal status in type-2 diabetes patients with chronic periodontitis under systemic administration of the drug NA.

MATERIALS AND METHODS

The research protocol was approved by the Institutional Human Ethical Committee before the initiation of the study. This study was carried out from December 2019 to March 2020 in Kandamkulathy Super Speciality Ayurveda Hospital, Kerala, and the fasting blood sugar level was assessed for patients, who were reporting for the treatment of DM. About 90 newly diagnosed mild-to-moderate forms of type-2 DM¹³ subjects with generalized chronic periodontitis with mild-to-moderate forms were selected according to the inclusion and exclusion criteria and were randomly divided into group A and group B of 45 patients in each group. All the subjects were informed about the study, and written informed consent was obtained prior to the initiation of the study.

Patients with fasting blood sugar levels greater than 126 mg/dL and having clinical attachment loss between 1 and 4 mm¹⁴ were included in the study. Female patients and patients with other forms of systemic illness (other than type-2 DM) were excluded.

Clinical parameters, including plaque index, probing pocket depth, clinical attachment level, and glycemic status, were assessed at baseline. Following initial periodontal clinical examination, the drug NA 2 gm twice daily for 3 months was prescribed after food by an Ayurvedic physician to all the patients enrolled in group A and group B, and scaling and root planing were completed only for group B patients. The patients were allowed to take other allopathic drugs advised by their physician with a minimum of 3 hours gap after or before taking NA. Patients were recalled for review, and all the parameters were reassessed at the end of the 1st, 2nd and 3rd months following interventions.

All patients were supplied with nonmedicated toothpaste and medium toothbrushes and instructed to brush twice daily using a modified bass brushing technique. Measures were taken to ensure that all the patients were taking the NA drug regularly, as confined to the group.

RESULTS

The study was conducted for a period of 3 months, and included 90 type-2 diabetic patients with mild-to-moderate periodontitis, with the greatest number of participants between 35 years and 50 years, and the mean value of 41.74 in group A and 41.98 in group B (Table 1).

DISCUSSION

In this study, there was an increase in the mean plaque score, mean probing pocket depth, and mean clinical attachment level (p < 0.001) from baseline to 3rd month in group A, while there was a reduction in the mean plaque score, probing pocket depth, and clinical attachment level (p < 0.001) in group B patients. The present results were in accordance with Buzinin et al.,¹⁵ who found an improvement in all the clinical parameters, including plaque score, PPD, and CAL following nonsurgical periodontal therapy. Similarly, Sinha et al.¹⁶ also observed an improvement in clinical parameters after scaling and root planing in type-2 diabetic patients with moderate generalized chronic periodontitis and hence is effective in conditioning the periodontal pockets.

In order to diagnose diabetes as per ICMR guidelines, FBS is suggested as the most common test with the cutoff point of FBS ≥126 mg/dL.¹⁷ In this study, 8-hour FBS ≥126 mg/dL was diagnosed as diabetes, which is in accordance with Khan et al.,¹⁸ who also found an elevated FBS level in suspected cases of type-2 DM. Chahkandi et al.,¹⁹ in their cross-sectional study, also observed an impaired fasting glucose in adolescents. A significant reduction in FBS values in both the groups of the study, with a more pronounced reduction in group B patients, who underwent SRP along with the antidiabetic drug was observed.

The above findings were in accordance with the study by Bedarkar,²⁰ who found a significant reduction in fasting and postprandial blood sugar levels in the NA drug-treated group along with reduction in signs and symptoms of the disease. Kashinath et al.²¹ also found similar results, where drug NA was administered to diabetic patients and found 8.6% and 15.7% reduction in FBS after 1 and 2 months, respectively. Punchihewa et al.,²² who evaluated the immediate effect of NA drug in the management of blood glucose levels in type-2 DM, reported that the NA drug did not effectively reduce the blood-glucose level, which is in contrast to the present study.

Nishamalaki drug is a unique ayurvedic formulation, prepared in a 1:1 ratio of gooseberry and turmeric, and is available in powder and tablet forms. Studies have shown that gooseberry reduces the blood-glucose levels by suppressing gluconeogenesis and glycogenolysis.²³ The extract of gooseberry also rises the β-cell size and number proving its antidiabetic activity through the upregulation of β-cell actions that decreases glucose intolerance and enhances insulin secretion.²⁴ Furthermore, it has strong antioxidant action, which reduces and prevents the damage to pancreas due to oxidative stress. Turmeric inhibits the reactive oxygen species production, playing a fundamental role, particularly for diseases related to oxidative stress and diabetes.

Various other studies^25,26 reported that scaling and root planing or SRP plus adjuvant treatment could improve glycemic control in patients with T2DM and CP, which is in accordance with our present results, where there is reduction in FBS in group B patients.

This study suggests that periodontal therapy along with the antidiabetic drug improves glycemic control. However, these results may be influenced by dietary factors, which were not monitored during this investigation. In this regard, it is important to highlight the fact that treating periodontal disease while addressing modifiable risk factors like diabetes control and diet will enhance the quality of patient care. This can possibly lead to more successful outcomes in our treatment of patients with periodontal disease.

The hypothesis that metabolic control of DM could be improved by the successful treatment of periodontitis along with the use of systemic drugs was confirmed by this study. The clinical and biochemical parameters were significant at baseline which indicates that the treatment outcome was highly influenced by the baseline values. At this juncture, we would like to emphasize that all the confounding variables associated with the study, the initial baseline mean value was found to be higher in both groups, which could also be a key contributing factor for marked response in diabetic patients with chronic periodontitis.

Thus, in our current study, significant improvements were seen with both the groups, but SRP along with the NA drug provided profound changes in all clinical and biochemical parameters than subjects treated with the antidiabetic drug alone, thus clinically establishing its pivotal role as an effective therapy in treating diabetes mellitus subjects with chronic periodontitis.

CONCLUSION

The results obtained appeared to demonstrate a strong, statistically significant association between the clinical improvement in the periodontal condition and improved metabolic control of diabetes. Moreover, adjunctive scaling and root planing a long with NA drug, having both antidiabetic and antioxidant properties improves the periodontal and metabolic parameters when compared with drug alone. These results can also be a starting point for further research on the efficiency of different antioxidant agents for prevention and treatment of periodontal disease in diabetic patients. The interpretation and result of the study are significant as they will guide not only the dentists for proper control and care of diabetic patients but also help in awareness of the public to consult a dentist well in time for better control of these chronic diseases.

ACKNOWLEDGMENTS

The author thanks the Kandamkulathy Super Speciality Ayurveda Hospital, Kerala, for granting permission to conduct the study.

REFERENCES

1. Zhang L, Henson BS, Camargo PM, et al. The clinical value of salivary biomarkers for periodontal disease. Periodontology 2000 2009;51:25–37. DOI: 10.1111/j.1600-0757.2009.00315.x.

2. Page RC, Kornman KS. The pathogenesis of human periodontitis: An introduction. Periodontology 2000. 1997;14:9–11. DOI: 10.1111/j.1600-0757.1997.tb00189.x.

3. Bullon P, Newman HN, Battino M. Obesity, diabetes mellitus, atherosclerosis and chronic periodontitis: A shared pathology via oxidative stress and mitochondrial dysfunction? Periodontol 2000 2014;64(1):139–153. DOI: 10.1111/j.1600-0757.2012.00455.x.

4. Popawska-Kita A, Siewko K, Szpak P, et al. Association between type 1 diabetes and periodontal health. Adv Med Sci 2014;59(1):126–131. DOI: 10.1016/j.advms.2014.01.002.

5. Lalla E, Cheng B, Lal S, et al. Periodontal changes in children and adolescents with diabetes. Diabetes Care 2006;29(2):295–299. DOI: 10.2337/diacare.29.02.06.dc05-1355.

6. Mealey BL. Periodontal disease and diabetes: A two-way street. J Am Dent Assoc 2006;137 Suppl:26S–31S. DOI: 10.14219/jada.archive.2006.0404.

7. Campus G, Salem A, Uzzau S, et al. Diabetes and periodontal disease: A case-control study. J Periodontol 2005;76(3):418–425. DOI: 10.1902/jop.2005.76.3.418.

8. Tsai C, Hayes C, Taylor GW. Glycemic control of type 2 diabetes and severe periodontal disease in the US adult population. Community Dent Oral Epidemiol 2002;30(3):182–192. DOI: 10.1034/j.1600-0528.2002.300304.x.

9. Nassar H, Kantarci A, Van Dyke TE. Diabetic periodontitis: A model for activated innate immunity and impaired resolution of inflammation. Periodontol 2000 2007;43:233–244. DOI: 10.1111/j.1600-0757.2006.00168.x.

10. Nesse W, Abbas F, van der Ploeg I, et al. Periodontal inflamed surface area: Quantifying inflammatory burden. J Clin Periodontol 2008;35(8):668–673. DOI: 10.1111/j.1600-051X.2008.01249.x

11. Nibali L, D’Aiuto F, Griffiths G, et al. Severe periodontitis is associated with systemic inflammation and a dysmetabolic status: A case-control study. J Clin Periodontol 2007;34(11):931–937. DOI: 10.1111/j.1600-051X.2007.01133.x.

12. Saxena A, Vikram NK. Role of selected Indian plants in management of type 2 diabetes: A review. J Altern Complement Med 2004;10(2):369–378. DOI: 10.1089/107555304323062365.

13. Joseph R, Nagrale AV, Joseraj MG, et al. Low levels of serum vitamin D in chronic periodontitis patients with type 2 diabetes mellitus: A hospital-based cross-sectional clinical study. J Indian Soc Periodontol 2015;19(5):501–506. DOI: 10.4103/0972-124X.167162.

14. Eke PI, Page RC, Wei L, et al. Update of the case definitions for population-based surveillance of periodontitis. J Periodontol 2012;83(12)1449–1454. DOI: 10.1902/jop.2012.110664.

15. Buzinin SM, Alabsi AM, Boon Tan AT, et al. Effects of nonsurgical periodontal therapy on clinical response, microbiological profile, and glycemic control in Malaysian subjects with type 1 diabetes. Scientific WorldJournal 2014;2014:232535. DOI: 10.1155/2014/232535.

16. Sinha S, Sonoo PR, Siddhartha R, et al. Effect of conventional periodontal treatment (scaling and root planing) on type-2 diabetic patient with moderate generalized chronic periodontitis: A clinical study. J Pharm Bioallied Sci 2021;13(Suppl 1):S706–S710. DOI: 10.4103/jpbs.JPBS_692_20.

17. ICMR Guidelines for Management of Type 2 Diabetes 2018.

18. Khan SB, Kapoor A, Nema SK, et al. A comparative study: Elevated HbA1C and fasting blood sugar levels in clinically suspected cases of Type-II DM. Int J Pathol: Res Pract 2018;7(8).

19. Chahkandi T, Taheri F, Bijari B, et al. Prevalence of high normal FBS and prediabetes among adolescents in Birjand, East of Iran. J Educ Health Promot 2015;4:68. DOI: 10.4103/2277-9531.162389.

20. Bedarkar PB. Alpha amylase and alpha glucosidase inhibitory activity of Amalaki Rasayana-An Ayurvedic formulation. Journal of Pharmaceutical Research 2017;6(11):994–1002. DOI: 10.20959/wjpr201711-9641.

21. Kashinath S, Sharma J, Kumar S, et al. A clinical study on the efficacy of wheat grass juice in Prameha. Int Res J Pharmacy 2012;(3)4. DOI: 10.7897/2230-8407.

22. Punchihewa TKG, Ekneligoda RV, Uyanege PP. Evaluation of the acute effect of Nishamalaki Churna in the management of blood glucose level in diabetes mellitus type 2. Int J Sci Res Eng Dev 2021;4(1). ISSN: 2581-7175.

23. Mirunalini S, Krishnaveni M. Therapeutic potential of Phyllanthus emblica (amla): The ayurvedic wonder. J Basic Clin Physiol Pharmacol 2010;21(1):93–105. DOI: 10.1515/jbcpp.2010.21.1.93.

24. Fatima N, Hafizur RM, Hameed A, et al. Ellagic acid in Emblica officinalis exerts anti-diabetic activity through the action on β-cells of pancreas. Eur J Nutr 2017;56(2):591–601. DOI: 10.1007/s00394-015-1103-y.

25. Ruoyan C, Qiulan L, Qiqi W, et al. Effect of non-surgical periodontal therapy on glycemic control of type 2 diabetes mellitus: A systematic review and Bayesian network meta-analysis. BMC Oral Health 2019;19(1):176. DOI: 10.1186/s12903-019-0829-y.

26. Mizuno H, Ekuni D, Maruyama T, et al. The effects of non-surgical periodontal treatment on glycemic control, oxidative stress balance and quality of life in patients with type 2 diabetes: A randomized clinical trial. PLoS One 2017;12(11):e0188171. DOI: 10.1371/journal.pone.0188171.