Does melatonin gel improve alveolar preservation? A triple-blind randomized controlled clinical trial
Abstract
Background: Preserving ridge volume after tooth extraction is essential for predictable implant outcomes. Various techniques and biomaterials have been proposed to minimize post-extraction dimensional changes. Melatonin, a pineal hormone, is an important mediator of new bone formation. The effect of melatonin gel incorporated into a porcine xenogeneic collagen sponge in post-extraction sockets has not been evaluated in humans, making this trial novel.
Purpose: To assess the effect of melatonin gel incorporated into a collagen sponge on intra-socket bone formation and tissue characteristics in post-extraction sockets.
Materials and methods: Twenty participants requiring extraction of premolars or molars with adjacent teeth were randomly allocated to test (n = 10) and control (n = 10) groups. After extraction, sockets were filled with xenogenic collagen sponge containing either melatonin gel (1.2 mg; test) or placebo gel (control). Ninety days later, during implant placement, bone samples were harvested using a trephine drill. Samples were processed for histomorphometric analysis of newly formed bone and connective tissue. Secondary outcomes included descriptive microscopic histology, quantitative microcomputed tomography (µCT) analyses and intra-alveolar volumetric analysis.
Results: Histomorphometry revealed significantly greater bone density in the test group (44.0%) than in the control group (35.4%; p = 0.0099), with a mean difference of 8.6% ± 3.2%. Microscopic evaluation…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 10 participants or records.
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