Clinical and Radiographic Assessment of the Osteogenic Effect of Melatonin in Immediate Implant Placement: A Pilot Randomized Clinical Trial.
Sponsor study identifier
interventional
16
1 country
1
Study Start
November 6, 2025
Actual (reported)Primary Completion
June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 6, 2025
Actual (reported)October 6, 2026
Actual (reported)October 9, 2026
Actual (reported)June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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.
Baseline (immediately post-operatively) and 6 months post-operatively.
Change in Primary and Secondary Implant Stability
Baseline (immediately after implant insertion), 1.5 months, and 3 months post-operatively.
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.
Participants undergo immediate dental implant placement in the posterior mandible following standard surgical protocol without melatonin gel application, sealed with a customized healing abutment.
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.
Department of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine - Future University in Egypt
Cairo, 43528, Egypt
Chen ST, Wilson TG Jr, Hammerle CH. Immediate or early placement of implants following tooth extraction: review of biologic basis, clinical procedures, and outcomes. Int J Oral Maxillofac Implants. 2004;19 Suppl:12-25.
S DS, Kamath D, Sinha A, Kamath D. Melatonin: The potential avenues in dentistry. F1000Res. 2025 Jan 14;14:77. doi: 10.12688/f1000research.159942.1. eCollection 2025.
Hosseinzadeh A, Bagherifard A, Sheibani M, Karimi-Behnagh A, Reiter RJ, Mehrzadi S. Significant Interaction between Melatonin and Titanium Bone Implants: Available Evidence and Future Research Directions. Curr Pharm Biotechnol. 2025;26(9):1258-1270. doi: 10.2174/0113892010300967240610111644.
First Submitted
October 6, 2026
First Posted
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Ravi Kiran S, Bammidi N, Kumar AK, Kumar PS, Karnam Y. Evaluation of the Effect of Topical Melatonin Application on Immediately Placed Dental Implants Using Cone Beam Computed Tomography (CBCT). Cureus. 2022 May 23;14(5):e25233. doi: 10.7759/cureus.25233. eCollection 2022 May.
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Yan W, Li C, Song X, Zhou W, Chen Z. Prophylactic melatonin for delirium in critically ill patients: A systematic review and meta-analysis with trial sequential analysis. Medicine (Baltimore). 2022 Oct 28;101(43):e31411. doi: 10.1097/MD.0000000000031411.
Zhao Y, Shao G, Liu X, Li Z. Assessment of the Therapeutic Potential of Melatonin for the Treatment of Osteoporosis Through a Narrative Review of Its Signaling and Preclinical and Clinical Studies. Front Pharmacol. 2022 May 11;13:866625. doi: 10.3389/fphar.2022.866625. eCollection 2022.
Huang X, Chen W, Gu C, Liu H, Hou M, Qin W, Zhu X, Chen X, Liu T, Yang H, He F. Melatonin suppresses bone marrow adiposity in ovariectomized rats by rescuing the imbalance between osteogenesis and adipogenesis through SIRT1 activation. J Orthop Translat. 2022 Oct 27;38:84-97. doi: 10.1016/j.jot.2022.10.002. eCollection 2023 Jan.
Maria S, Samsonraj RM, Munmun F, Glas J, Silvestros M, Kotlarczyk MP, Rylands R, Dudakovic A, van Wijnen AJ, Enderby LT, Lassila H, Dodda B, Davis VL, Balk J, Burow M, Bunnell BA, Witt-Enderby PA. Biological effects of melatonin on osteoblast/osteoclast cocultures, bone, and quality of life: Implications of a role for MT2 melatonin receptors, MEK1/2, and MEK5 in melatonin-mediated osteoblastogenesis. J Pineal Res. 2018 Apr;64(3):10.1111/jpi.12465. doi: 10.1111/jpi.12465. Epub 2018 Jan 17.
Vaseenon S, Chattipakorn N, Chattipakorn SC. Effects of melatonin in wound healing of dental pulp and periodontium: Evidence from in vitro, in vivo and clinical studies. Arch Oral Biol. 2021 Mar;123:105037. doi: 10.1016/j.archoralbio.2020.105037. Epub 2021 Jan 6.
Hardeland R, Pandi-Perumal SR. Melatonin, a potent agent in antioxidative defense: actions as a natural food constituent, gastrointestinal factor, drug and prodrug. Nutr Metab (Lond). 2005 Sep 10;2:22. doi: 10.1186/1743-7075-2-22.
Tian Y, Ming J. Melatonin inhibits osteoclastogenesis via RANKL/OPG suppression mediated by Rev-Erbalpha in osteoblasts. J Cell Mol Med. 2022 Jul;26(14):4032-4047. doi: 10.1111/jcmm.17440. Epub 2022 Jun 21.
Hu W, Deng C, Ma Z, Wang D, Fan C, Li T, Di S, Gong B, Reiter RJ, Yang Y. Utilizing melatonin to combat bacterial infections and septic injury. Br J Pharmacol. 2017 May;174(9):754-768. doi: 10.1111/bph.13751. Epub 2017 Mar 21.
Favero G, Franceschetti L, Bonomini F, Rodella LF, Rezzani R. Melatonin as an Anti-Inflammatory Agent Modulating Inflammasome Activation. Int J Endocrinol. 2017;2017:1835195. doi: 10.1155/2017/1835195. Epub 2017 Oct 1.
Cuzzocrea S, Reiter RJ. Pharmacological actions of melatonin in acute and chronic inflammation. Curr Top Med Chem. 2002 Feb;2(2):153-65. doi: 10.2174/1568026023394425.
Permuy M, Lopez-Pena M, Gonzalez-Cantalapiedra A, Munoz F. Melatonin: A Review of Its Potential Functions and Effects on Dental Diseases. Int J Mol Sci. 2017 Apr 19;18(4):865. doi: 10.3390/ijms18040865.
Sola-Ruiz MF, Perez-Martinez C, Labaig-Rueda C, Carda C, Martin De Llano JJ. Behavior of Human Osteoblast Cells Cultured on Titanium Discs in Relation to Surface Roughness and Presence of Melatonin. Int J Mol Sci. 2017 Apr 13;18(4):823. doi: 10.3390/ijms18040823.
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October 9, 2026
Study Start
November 6, 2025
Actual (reported)Primary Completion
June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 15, 2026
Record last verified: 2026-10
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.
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Source: ClinicalTrials.gov.
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