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RECRUITING Not applicable ClinicalTrials.gov

Melatonin Effect on Immediate Dental Implants in the Posterior Mandible

Sponsor: Future University in Egypt • ClinicalTrials.gov ID: NCT07869030

Registry updated: 2026-10-15
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Description

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.

Interventions

  • 1% w/w Melatonin Gel (Drug)
    Topical 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)
    Standard 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.

Eligibility criteria

Inclusion Criteria: * 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 who provide written informed consent and agree to attend follow-up visits. Exclusion Criteria: * 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. * Sites with acute infection, cystic lesions, or pathology. * Bruxism or parafunctional habits. * Use of medications affecting bone turnover (e.g., bisphosphonates, corticosteroids). * Poor compliance or unwillingness to return for follow-up visits.

Conditions

Dental Implant Immediate Dental Implant Placement Alveolar Bone Loss Bone Density Osseointegration

Locations

  • Department of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine - Future University in Egypt — Cairo, Egypt
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record