A Phase 4 interventional study of Melatonin gel mixed with xenograft and Xenograft in Periodontal Disease, AVDC Stage 3, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 35 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-08-29.
Sponsored by Ain Shams University · Phase 4, Interventional, and Treatment
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.
830 studies on the registry are indexed under Periodontal Diseases; 188 are open to participants now.
This study's enrollment of 20 is below the median of 45 across 530 interventional studies indexed under Periodontal Diseases.
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Patients diagnosed with periodontitis Stage III (Caton et al., 2018; Papapanou et al., 2018).
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:
Ten patients with stage III periodontitis with vertical bone defects will be subjected to application of particulate xenograft mixed with 5% melatonin gel.
Drug: Melatonin gel mixed with xenograft
Ten patients with stage III periodontitis with vertical bone defects will be subjected to application of particulate xenograft alone.
Other: 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.
Application of Xenograft alone for the surgical management of intrabony periodontal defects.
- Radiographic evaluation of the changes in the intrabony defect
The amount of bone gain in millimeters in follow up radiograph compared to preoperative radiograph
Time frame: 6 months
Clinical evaluation of the changes in periodontal parameters
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: Baseline and 6 months
Evaluation of surgical wound healing
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.
Time frame: 1 and 2 weeks after surgery.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Ain Shams University