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NCT06821425

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

Completed Phase 4 Last updated 29 August 2025
What this trial tests

Phase 4 trial testing Melatonin gel mixed with xenograft in Periodontal Disease, AVDC Stage 3 in 20 participants. Completed in 1 August 2025.

Timeline
1 January 2025
Primary endpoint
1 August 2025
1 August 2025

Quick facts

Lead sponsorAin Shams University
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment20
Start date1 January 2025
Primary completion1 August 2025
Estimated completion1 August 2025
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Ain Shams University

Who can join

Adults 35 to 55, any sex, with Periodontal Disease, AVDC Stage 3. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Periodontal Disease, AVDC Stage 3

Currently open trials in the same condition.

Other Ain Shams University trials

Trials by the same sponsor.

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Data sources for this page

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