Indocyanine-mediated antimicrobial photodynamic therapy promotes superior clinical effects in stage III and grade C chronic periodontitis among controlled and uncontrolled diabetes mellitus: A randomized controlled clinical trial

Abstract

Background: The aim of this randomized controlled clinical trial was to evaluate the efficacy of indocyanine-green mediated antimicrobial photodynamic therapy (ICG-aPDT) in the treatment of stage III grade C periodontitis in terms of clinical, microbiological, and immune-inflammatory parameters in patients with well-controlled and poorly-controlled form of type-2 diabetes mellitus (T2DM). Materials and methods: Subjects with a diagnosis of chronic periodontitis according to the new classification and case definition of periodontitis [probing depth (PD): ≥6 mm, interdental clinical attachment loss (CAL): ≥5 mm and bone loss extending to mid-third of root and beyond (≥3 mm)] were recruited. Subjects were grouped on the basis of well-controlled and poorly-controlled diabetic status. Two subgroups were made according to the treatment modality (RSD versus ICG-aPDT/RSD) in each group. A split-mouth design was used in which one site was designated for control (RSD alone treatment) while the other contralateral site was chosen for test treatment (ICG-aPDT/RSD) in all the patients. Periodontal parameters included the measurement of plaque score (PS), bleeding on probing (BOP), probing depth (PD), clinical attachment level (CAL) and alveolar bone levels (ABL). Identification of Porphyromonas gingivalis and Tannarella forsythia through PCR was executed using species specific primers. Gingival crevicular fluid samples were then analyzed using enzyme-linked immunosorbent assay for the quantification of interleukin (IL)-17 and interferon (IFN)-γ. All the clinical, microbiological, and immunological parameters were assessed using repeated measure ANOVA for intra and inter-group comparisons. The p-value significance was set at 0.05. Results: The mean age of the 50 patients was 44.7 ± 7.4 years. Systemic parameters suggest no significant change between the times in either HbA1c or serum CRP levels in any of the groups. A statistically significant reduction for BOP was noted for ICG-aPDT group for non-diabetic subjects at 3 months follow up only, while a significant reduction was seen at both 3 months and 6 months among well-controlled and poorly-controlled T2DM subjects (p<0.05). For PD and CAL, a significant improvement was seen for ICG-aPDT group among non-diabetic and well-controlled T2DM subjects at both 3- and 6-months follow up, while a significant reduction was seen at only 3 months among poorly-controlled T2DM subjects. A significant reduction was seen for ICG-aPDT group compared to RSD group for both bacteria in all the three groups at 6 months follow up (p<0.05). Conclusion: ICG-aPDT significantly improved clinical and antimicrobial parameters in well-controlled and poorly-controlled T2DM having stage III and grade C periodontitis. Glycemic status did not have negative impact in the reduction of periodontal parameters in either types of T2DM. Trial registration: The present RCT was registered in the clinicaltrials.gov under the identifier: NCT04857346