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Published on: October 23, 2018
Does melatonin gel improve alveolar preservation? A triple-blind randomized controlled clinical trial
Ingrid Chaves Cavalcante Kischinhevsky1,2, Adriana Terezinha Neves Novellino Alves3, Caio Márcio Sorrentino de Freitas Farias Dos Santos4
1Phd Student Post Graduation Program, Dental School, Fluminense Federal University, Niteroi, RJ, Brazil.
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 showed increased osteoblastic activity in the test group. Quantitative µCT analysis confirmed more new bone formation in the test group, although qualitative bone characteristics did not differ between groups. The intra-alveolar bone volume formed was numerically higher in the test group than in the control group.
Conclusion:
Incorporating melatonin gel into a collagen sponge enhanced bone repair in human post-extraction sockets over 90 days. This clinical trial is registered at the Brazilian Clinical Trials Registry (ReBEC; https://ensaiosclinicos.gov.br): RBR-67jkxsj.
