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Scholars Journal of Dental Sciences | Volume-13 | Issue-03
Efficacy and Safety of Zinc Citrate-Based Dental Gel in Subjects with Periodontitis and Gingivitis: A Multicenter, Randomized, Controlled, Open-Label Study
Henil Shah, Harsh Shah, Navita Budhiraja, Preeti Kumbhar, Arti Sanghavi, Syed Mujtaba Hussain Naqvi, Simran Sethi, Parth Joshi, Priyanka Madiwale
Published: March 30, 2026 |
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Pages: 45-67
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Abstract
This study evaluated the clinical efficacy and safety of Stolin-R toothpaste, formulated with Zinc Citrate (2%), Alum (0.2%), Sodium Fluoride (990 ppm), and Xylitol (10%), in improving gingival health, plaque control, and halitosis in healthy individuals and patients with Type 2 Diabetes Mellitus (T2DM). A 30-day interventional study was conducted in healthy individuals and patients with Type 2 Diabetes Mellitus (T2DM), comparing Stolin-R toothpaste with a standard comparator. Gingival Index (GI), Plaque Index (PI), Bleeding on Probing (BOP), periodontal pocket depth, halitosis scores, and gum health characteristics (color, consistency, texture) assessments were performed at baseline, Day 15, Day 30, and post-discontinuation (Day 60). Safety was monitored through adverse event reporting. Stolin-R toothpaste showed markedly superior outcomes across all parameters. Gingival Index decreased by 64.42% with Stolin-R versus 16.93% with the comparator, reflecting significantly lower gingival inflammation. Plaque Index declined by 69.72% in healthy subjects and 62.50% in T2DM subjects, compared to modest improvements with the comparator. Bleeding gums resolved completely in healthy subjects and nearly resolved in T2DM subjects by Day 30. Periodontal pocket depth decreased by 24.76% in healthy individuals and 17.11% in T2DM subjects, while the comparator exhibited negligible changes. Halitosis scores improved by 97.5% in healthy subjects and 64.93% in T2DM subjects, reflecting strong anti-malodor activity. Gum health parameters color, consistency, texture, and bleeding normalized completely by Day 30 and sustained through Day 60 post-discontinuation. No local intolerance, adverse events, or serious safety concerns were reported throughout the study. Overall, Stolin-R toothpaste offers superior oral health benefits through a synergistic formulation combining antimicrobial, anti-inflammatory and astringent effects. It significantly improves gingival health, plaque control, and


