Evaluation of Clinical Outcomes of Adjunctive Topical Melatonin Gel in Non-Surgical Periodontal Therapy: A Randomized Placebo-Controlled Trial in Karachi

Periodontitis is a chronic inflammatory disease affecting the supporting structures of the teeth and is one of the leading causes of tooth loss worldwide. The disease is initiated by pathogenic bacterial biofilm and progresses through a complex host inflammatory response that results in destruction of the periodontal ligament, alveolar bone loss, periodontal pocket formation, and clinical attachment loss. In Pakistan, periodontitis has a high prevalence and represents a significant oral health burden affecting quality of life and overall health.

Non-surgical periodontal therapy (NSPT), consisting primarily of scaling and root planing, is considered the gold standard treatment for periodontitis. NSPT effectively reduces microbial load and improves periodontal clinical parameters, including plaque index (PI), gingival index (GI), probing pocket depth (PPD), and clinical attachment level (CAL). However, despite the effectiveness of mechanical debridement, complete resolution of inflammation and periodontal tissue regeneration may not always be achieved, leading researchers to investigate adjunctive therapeutic approaches.

Melatonin is a naturally occurring hormone mainly secreted by the pineal gland and is known for regulating circadian rhythm. In addition to its physiologic role, melatonin possesses antioxidant, anti-inflammatory, immunomodulatory, and bone-regenerative properties. Experimental and clinical studies have suggested that melatonin may reduce oxidative stress, regulate inflammatory mediators, inhibit tissue destruction, and promote osteoblastic activity and collagen formation. These biologic effects indicate its potential usefulness as an adjunctive agent in periodontal therapy.

Previous international studies have demonstrated promising results with topical melatonin application in periodontal treatment, showing improvements in inflammatory parameters and periodontal healing. However, there is limited evidence regarding its clinical effectiveness in the Pakistani population, and no randomized placebo-controlled clinical trial has been conducted locally to evaluate its adjunctive role with NSPT.

This study is designed as a randomized, double-blind, placebo-controlled clinical trial to assess the clinical outcomes of adjunctive topical melatonin gel in patients undergoing non-surgical periodontal therapy. A total of 30 patients diagnosed with periodontitis will be recruited from the Department of Periodontology at Liaquat College of Medicine & Dentistry, Karachi. Eligible participants will include adults aged 18-45 years who are systemically healthy or medically controlled and diagnosed with periodontitis with clinical attachment loss between 3-4 mm.