This pilot randomized controlled clinical trial aims to evaluate the feasibility, clinical safety, and preliminary radiographic osteogenic effects of applying topical 1% w/w melatonin gel during immediate implant placement in the posterior mandible. The study assesses surgical feasibility, soft-tissue healing, bone density, buccal bone thickness, and implant stability to provide preliminary effect size and variance estimates to inform future definitive clinical trials.
Patients aged 20-50 years.
Indicated for extraction and immediate implant placement in the posterior mandibular molar region.
Good oral hygiene and compliance with postoperative instructions.
Non-smokers or light smokers (≤10 cigarettes/day).
Patients with systemic diseases affecting bone metabolism or wound healing (e.g., uncontrolled diabetes, osteoporosis).
Heavy smokers (>10 cigarettes/day).
History of head and neck radiotherapy or chemotherapy.
Pregnant or lactating women.
Parallel
1% w/w Melatonin Gel
DrugTopical application of 1% w/w melatonin gel into the peri-implant socket gap immediately prior to dental implant insertion.
Standard Immediate Dental Implant Placement
Procedure/SurgeryStandard surgical placement of an immediate dental implant into a fresh extraction socket in the posterior mandible, using a customized healing abutment to seal the socket.
Change in Peri-Implant Bone Density
Change in peri-implant bone density measured in Hounsfield Units (HU) using Cone Beam Computed Tomography (CBCT) scan cross-sections at the peri-implant defect area.
Change in Buccal Bone Thickness
Change in buccal bone plate thickness measured in millimeters (mm) on CBCT cross-sectional views at predefined levels relative to the implant shoulder.
Change in Primary and Secondary Implant Stability
Implant stability measured using the AnyCheck device on the Implant Stability Test (IST) scale. IST values range from 30 to 99, where higher values indicate higher implant stability.
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