Title: 

Comparative evaluation of clinical outcomes in nonsurgical periodontal therapy with and without multi-nutrient supplements: a randomized clinical controlled trial

Introduction:

The etiology of periodontal disease is complex. It is well acknowledged that the development of periodontitis is a complex procedure when a massive host reaction and related tissue loss result from bacterially generated inflammation that is altered by environmental, genetic, and epigenetic variables. It is the primary cause of tooth loss and it is represented by the reduction of alveolar bone and the supporting periodontal ligament.

According to recent studies, periodontal disorders are closely linked to dietary practices and inadequate consumption of particular vitamins and minerals. Dietary nutrients have an effect on tooth development and a person’s vulnerability to periodontal diseases. Dietary variables can also affect the virulence of certain bacteria, the formation of dental plaque, and the acidity and content of saliva, all of which increase the risk of periodontitis.

The elimination and reduction of local etiological factors, is the main objective in initial periodontal therapy. Thus scaling, root planning, elimination of occlusal interferences (if any) and introduction of proper oral hygiene methods have been considered primary procedures of the pre-surgical phase of periodontal therapy.

Since James Lind used citrous fruits to treat scurvy, people have been aware of the impact that nutrition has on health. The role of nutrients as stated in previous literature, possess antioxidant qualities and could specifically target NLRP3 inflammasomes, which are implicated in inflammatory reactions mediated by cytokines and chemokines. Supplements may also present intriguing therapy alternatives for people with periodontitis, as the depletion of micronutrients in food caused by civilization is becoming a growing problem.

This clinical trial seeks to assess the impact of multi- nutrient supplements on clinical outcomes following NSPT in participants with Stage-III and Stage-IV periodontitis, as compared to NSPT alone.

Methodology:

This study will be conducted as a randomized, controlled, single-blind, parallel-arm clinical trial at a dental institution affiliated with MUHS, Nashik, following institutional ethical approval. Fifty participants aged 18 to 60 years diagnosed with Stage-III or Stage-IV periodontitis will be randomly assigned into two groups: Group A will undergo NSPT alone, while Group B (25 samples each group) will receive NSPT along with a commercially available multi-nutrient supplement for two months. Participants will meet specific inclusion criteria, including a minimum of 18 scorable teeth and evidence of deep periodontal pockets and attachment loss. Individuals with recent antibiotic use, systemic illnesses, smoking habits, or nutrient allergies will be excluded.

Clinical parameters including probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), plaque index (PI), and gingival index (GI) will be recorded at baseline, 3 months, and 6 months. Randomization will be done through simple random sampling, and the study will be single-blinded to ensure unbiased evaluation.

Statistical analysis will be performed using SPSS v26, with normality assessed via Shapiro-Wilk and Kolmogorov-Smirnov tests. Inter- and intra-group comparisons will be analyzed using appropriate statistical tests such as paired/unpaired t-tests, Mann-Whitney U, and ANOVA, with a significance level set at p < 0.05. A total of 50 participants (25 per group) will be included, factoring in a 15% attrition rate to maintain study power at 80% with a 95% confidence interval.