NCT06821425

Melatonin Gel as an Adjuvant in the Surgical Management of Intrabony Defects

Melatonin Gel as an Adjunct to Xenograft in the Surgical Management of Intrabony Periodontal Defects (A Randomized Controlled Clinical Study)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 35 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Surgical periodontal therapy is a commonly employed treatment approach aimed at arresting disease progression and promoting tissue regeneration. Despite advancements in surgical techniques, adjunctive therapies are being explored to enhance the outcomes of periodontal surgical debridement. Melatonin, a hormone primarily known for its role in regulating the sleep-wake cycle, has emerged as a promising candidate for periodontal therapy. It possesses potent antioxidant, anti-inflammatory, and immunomodulatory properties, which make it an attractive therapeutic agent for treating periodontitis. Additionally, melatonin has been linked to bone metabolism, with evidence suggesting its involvement in bone formation and remodeling processes. Bone regeneration is a vital aspect of periodontal therapy, as the restoration of lost osseous structures is crucial for long-term stability of affected teeth. Previous studies have suggested that melatonin may exert positive effects on bone formation by promoting osteoblast differentiation, stimulating matrix synthesis, and inhibiting osteoclast activity. However, limited research has been conducted to specifically evaluate its influence on bone regeneration in the context of surgical periodontal flap therapy.

Conditions

• Periodontal Disease, AVDC Stage 3

Interventions

Type	Name	Description
DRUG	Melatonin gel mixed with xenograft	This study will be conducted to evaluate the effect of melatonin (5% gel) when used as an adjunct to xenograft for the surgical management of intrabony periodontal defects.
OTHER	Xenograft	Application of Xenograft alone for the surgical management of intrabony periodontal defects.

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2025-02-12
• Last updated: 2025-08-29

Locations

1 site across 1 country: Egypt