Faculty of Dentistry, Ain Shams University
Cairo, 11511, Egypt
NCT Number: NCT06821425
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.
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Notify Me35 year–55 year
All sexes
Interventional
Phase 4
Cairo, 11511, Egypt
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Test site criteria: (probing pocket depth ≥6mm and CAL ≥5mm and 3-wall intrabondy defect). All these criteria will be determined after phase I conventional periodontal therapy.
Exclusion criteria
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.
Application of Xenograft alone for the surgical management of intrabony periodontal defects.
Time frame: 6 months
The amount of bone gain in millimeters in follow up radiograph compared to preoperative radiograph
Time frame: Baseline and 6 months
The amount of reduction in Probing pocket depth (PD) in mm The new level of clinical attachment (CAL) in relation the CEJ in mm
Time frame: 1 and 2 weeks after surgery.
Early Healing Index (EHI) to assess the quality of a wound in the days or weeks following a procedure, developed by Wachtel et al. to evaluate flap closure, the presence and amount of fibrin (a blood clot component), and the degree of tissue necrosis. A lower EHI score (such as 1-3) indicates better, complete healing, whereas higher scores (e.g., 4-5) suggest incomplete or poor healing.
Ain Shams University
Other
Melatonin Gel as an Adjunct to Xenograft in the Surgical Management of Intrabony Periodontal Defects (A Randomized Controlled Clinical Study)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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