Impact of resveratrol supplementation on clinical parameters and inflammatory markers in patients with chronic periodontitis: a randomized clinical trail

Subjects and study design

In this randomized, double-blind clinical trial, 40 periodontitis patients referring to the Periodontics Department of Dental School, Shahid Sadoughi University of Medical Sciences, Yazd, were selected. According to the principles of the Helsinki declaration, after examination and diagnosis of periodontal symptoms and considering inclusion and exclusion criteria, the necessary information was provided, and written consent was obtained. Then, the subjects were randomly assigned to two groups: case (n = 20) and control (n = 20). The patients were free to leave the study at any time they wished.

The inclusion criteria consisted of an age range of 30–60 years and moderate to severe periodontitis. The exclusion criteria consisted of pregnancy, lactation, traveling for > 2 weeks, smoking, taking immunosuppressive medications, taking non-steroidal anti-inflammatory drugs, antihypertensive agents, antibiotics drugs, anti-coagulant drugs like warfarin, taking insulin, and patients treated for uterine, breast, and ovarian cancer, patients with advanced renal and hepatic diseases, those with an allergy to grapes, blackberry, or blueberry, history of periodontitis treatment in the past six months and patients with active oral disease like pemphigus, leukoplakia.

This clinical trial was approved by the Ethics Committee of Shahid Sadoughi University of Medical Sciences under the code IR.SSU.REC.1396.206, and the IRCT Registration code was IRCT20171015036782N6.

Periodontal examination

Periodontitis patient with stage II (moderate periodontitis) to stage IV (advanced periodontitis with extensive tooth loss) based on clinical attachment loss (CAL) of ≥ 3 mm around the teeth and disease severity according to 2017 international periodontology workshop were selected. As all patients in our study didn’t have full mouth periapical radiography and no risk factor that may affect systemic health according to eligible patients, the grade of periodontitis was estimated with moderate progression rate (grade B).

For all the patients, the probing depth (PD) was measured by the Williams probe, which is a distinctive and calibrated device, at six points of each tooth: mesiobuccal, mid-buccal, distobuccal, mesiolingual, mid-lingual, and distolingual. These areas were coded, and 10 points were randomly selected from at least three quadrants for the post-intervention clinical measurements [19].

Clinical attachment loss (CAL) was also recorded in these areas by measuring the distance between the CEJ (cementoenamel junction) and the pocket depth. In addition, the O’Leary plaque index [23] was recorded after chewing disclosing agent pills, and the gingival bleeding index [24] was calculated 30 s after gentle probing of the sulcus of teeth. All the clinical parameters were performed by the same operator and re-measured four weeks after the intervention to compare with the initial findings.

Biochemical measurement

Salivary samples of all the patients were collected at baseline and four weeks after the intervention to assess IL-8 and IL-1β levels. All the salivary samples were collected between 9 a.m. and 12 p.m. The patients were asked to refrain from brushing 12 h before sampling and refrain from eating, drinking, and chewing gum two hours before the sampling. To investigate the inflammatory interleukin levels, the unstimulated saliva of the patients was collected before any action. The patients were asked to avoid swallowing their saliva for five minutes, and then the accumulated saliva in the oral cavity floor was passively drooled into sterile disposable test tubes [25]. The samples were then immediately transferred to the laboratory in an ice chamber and centrifuged at 2500 rpm for 20 min at 4 °C. Then the supernatant was frozen at -80ºC until the biochemical tests. The biochemical tests were performed within six months from the moment of freezing. The salivary levels of IL-8 and IL-1β were measured by an ELISA laboratory kit (Karmania PARS Gene, Tehran, Iran).

Intervention

For all the patients (both case and control groups), scaling and root planning by an ultrasonic scaler (ultrasonic piezo scaler Uds-K, Woodpecker, China) was performed. Patients in the case group received 480 mg (2 capsules) of resveratrol (HERBAFIT Co.) daily for four weeks, while patients in the control group received 480 mg (2 capsules) of placebo containing starch [19]. Patients were asked to take these capsules in the morning after breakfast. During these four weeks, all the patients were contacted three times a week to ensure they took the capsules. All the patients also underwent periodontal examinations and treatment, including scaling and root planning, if needed, during the study. Oral hygiene instructions, including correct tooth brushing and dental flossing, were given to them. After four weeks, the patients were re-examined. All the procedures were done by the same operator.

Outcome (primary and secondary)

The primary outcome of this study was to determine the CAL and PD before and after the intervention. The secondary outcome of this study was to evaluate the O’Leary plaque index, BI and the mean salivary levels of IL-8 and IL-1β before and after intervention between two groups.

Sample size calculation

Considering a 5% significance level, 80% test power, and according to the results of a previous study [19] and a standard deviation of S = 0.6, to achieve a significant difference of at least one unit in the mean pocket depth, 20 subjects were included in each group.

Statistical analysis

SPSS 23.0 was used to compare the results and determine the differences in different experiments. A Kolmogorov-Smirnov test was to assess distribution normality. Also, the chi-squared test, independent-samples t-test, and paired-samples statistics were used to compare the changes between the two groups. Statistical significance was set at P < 0.05.

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