An interventional study of 1% w/w Melatonin Gel and Standard Immediate Dental Implant Placement in Dental Implant, Immediate Dental Implant Placement and Alveolar Bone Loss, sponsored by Future University in Egypt. Recruiting at 1 site in Egypt. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Future University in Egypt · Not applicable, Interventional, and Treatment
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.
This study is a pilot randomized controlled clinical trial conducted at Future University in Egypt. Given the technical complexity of immediate implant placement in the posterior mandible combined with customized healing abutments, this pilot study evaluates a sample of 16 participants (8 per group) to assess protocol feasibility, evaluate soft-tissue healing profiles, and estimate outcome variability.
Study Design \& Intervention:
Outcome Assessment:
304 studies on the registry are indexed under Alveolar Bone Loss; 77 are open to participants now.
This study's planned enrollment of 16 is below the median of 25 across 261 interventional studies indexed under Alveolar Bone Loss.
Browse Alveolar Bone Loss studies →Future University in Egypt is the lead sponsor of 103 studies on the registry; 30 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants undergo immediate dental implant placement in the posterior mandible with application of 1% w/w melatonin gel into the extraction socket gap prior to implant insertion, sealed with a customized healing abutment.
Drug: 1% w/w Melatonin Gel · Procedure: Standard Immediate Dental Implant Placement
Participants undergo immediate dental implant placement in the posterior mandible following standard surgical protocol without melatonin gel application, sealed with a customized healing abutment.
Procedure: Standard Immediate Dental Implant Placement
Topical application of 1% w/w melatonin gel into the peri-implant socket gap immediately prior to dental implant insertion.
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.
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.
Time frame: Baseline (immediately post-operatively) and 6 months post-operatively.
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.
Time frame: Baseline (immediately post-operatively) and 6 months post-operatively.
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.
Time frame: Baseline (immediately after implant insertion), 1.5 months, and 3 months post-operatively.
Plan to share: Yes — De-identified individual participant data (IPD) regarding implant stability values (IST as measured by the AnyCheck device) and bone density values (from CBCT analysis) will be shared. Data will be made available to researchers who provide a methodologically sound proposal for secondary analysis. Data access requests should be directed to the principal investigator.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will be available starting 6 months after the publication of the final study results and will remain accessible for 5 years.
Access criteria: De-identified individual participant data (IPD) will be available to researchers who provide a methodologically sound proposal to achieve the aims in the approved proposal. Proposals should be submitted to the principal investigator via email. Access will be provided following the signing of a data access agreement to protect participant privacy.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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