Clinical efficacy of scaling and root planing with and without metronidazole on glycemic control: three-arm randomized controlled trial

Abstract

Background Treating periodontitis through non-surgical periodontal therapy (NSPT) may improve glycemic control in type-2 Diabetes Mellitus (T2DM) patients. However, the evidence to maintain this improvement beyond four months is insufficient. Hence, this trial was conducted to assess clinical efficacy of NSPT on glycemic control in T2DM patients. Methods This three-arm randomized controlled trial recruited 150 known T2DM participants (35–65 years), suffering from moderate to severe periodontitis, having HbA1c level ≥ 6.5% at baseline. Participants were followed up at 3 and 6 months. Intervention for test group-1 included scaling and root planing (SRP) with metronidazole (MET) and oral hygiene instructions (OHI). Test group-2 was intervened with SRP + OHI and control group with OHI only. Stata v. 14 was used to observe inter and intragroup mean changes in glycemic [glycated hemoglobin (HbA1c), fasting blood glucose (FBG)] and periodontal variables [bleeding on probing (BOP), periodontal pocket depth (PPD), clinical attachment loss (CAL)] using ANOVA and RMANOVA. Proportion of change in outcome variable (HbA1c) was assessed between treatment groups using chi-square test. Change was considered significant at p-value ≤ 0.05. Results A significant reduction was observed in BOP, PPD, CAL, HbA1c and FBG over time [p < 0.05]. Significant reductions were observed in same variables in both test groups in comparison to control arm [p < 0.05]. No change between the two test groups was observed [p > 0.05]. Conclusion Scaling and root planing improves glycemic control of T2DM patients independently of the use of MET. Therefore, SRP after every 6 months may be suggested and included as a part of overall diabetes management for patients suffering from T2DM. Clinical trial registration NCT 03,343,366 [Date of Registration: 17/11/2017]

Effects of Metronidazole as an Adjunct to Non-Surgical Periodontal Therapy on Insulin Resistance in Type 2 Diabetics

“…With respect to the treatment arms, there was no statistical difference (p > 0.05) between the participants allocated to the three groups at baseline. This result is presented elsewhere [21]. The total number of participants who completed the 3-month follow-up was n = 97, and the total number of participants who completed the 6-month follow-up was n = 74, with n = 24 in the SRP with MET group, n = 26 in the SRP without MET group, and n = 24 in the control arms.…”

“…The current trial results, compared to the HbA1c levels study that was previously published, allows a conclusion to be drawn, based on causality, that SRP with or without MET is equally effective in controlling the glycemic levels of T2DM patients [21]. Since the elevated pro-inflammatory markers in periodontal inflammation are suggested by the researchers to elevate IR in diabetics, there was a need to look into this change after T2DM patients were given antibiotics as an intervention [22].…”

“…Although the idea was to recruit larger numbers of participants for the trial to assess the primary outcome that is HbA1c, there was a limitation in retaining this larger number at the 3-month and 6-month follow-ups. This limitation was due to the reason that our trial participants were unable to turn up for their follow-up visits in a fasting state, which was required to assess blood glucose and serum insulin levels as per protocol [21]. This resulted in compromising the sample size.…”

“…The trial was registered at clinicaltrials.gov (NCT 03343366) and was conducted in line with the CONSORT guidelines [20,31]. The study flow chart is published elsewhere [21]. The ethical approval was sought by the institute (IRB-900/DUHS/Approval/2017/146) and the detailed methodology, along with the description of the target population, is presented elsewhere [21].…”

“…The current trial is aimed at evaluating the effect of periodontal treatment, scaling and root planing (SRP), with and without metronidazole (MET) on glycemic control registered by clinicaltrials.gov (accessed on 6 September 2021) [20]. A paper has already been published that evaluated the effects of metronidazole (MET) on glycemic control with HbA1c levels as the primary outcome variable [21]. The current paper is an addition that intends to report the results of the same trial with respect to the HOMA-IR levels of T2DM patients after periodontal intervention.…”