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Background <p> This study aims to evaluate and compare the effectiveness of 1% melatonin gel combined with demineralized freeze-dried bone allograft (DFDBA) versus DFDBA alone in treating intrabony periodontal defects in Stage II &amp; III periodontitis. Clinical and radiographic outcomes were assessed using cone-beam computed tomography (CBCT), along with analysis of gingival crevicular fluid (GCF) levels of receptor activator of nuclear factor-kappa B ligand (RANKL) and osteoprotegerin (OPG).</p> Methodology <p> A prospective, randomized, controlled, single-blinded clinical trial was conducted on 20 patients with 20 intrabony defects. The control group received DFDBA alone, while the test group received a combination of 1% melatonin gel and DFDBA. Clinical parameters Clinical Attachment Level (CAL) and Probing Pocket Depth (PPD) were evaluated at baseline, 3, and 6 months. Using cone beam computed tomography (CBCT) radiographic parameters linear bone fill and bone volume and GCF biomarkers (RANKL and OPG) were assessed at baseline and 6 months. Plaque Index (PI) and Sulcus Bleeding Index (SBI) were secondary outcomes. CAL change served as the primary outcome variable.</p> Results <p> After 6 months, the test group showed a mean CAL gain of 3.10 ± 0.87 mm and the control group 4.00 ± 1.85 mm, which was not statistically significant between the groups; however, intra-group comparison revealed a statistically significant CAL gain from baseline in both groups. Both groups showed improvements in assessed parameters, however, the test group demonstrated significantly greater bone fill (1.88 ± 0.26 mm vs. 1.16 ± 0.38 mm) and bone volume gain (22.67 ± 1.36 mm³ vs. 14.78 ± 0.5 mm³; <i>p</i>&lt; 0.000). Greater reduction in PPD and gain in CAL were noted in the test group. GCF analysis revealed a significant increase in OPG (99.87 ± 15.07) and reduction in RANKL levels (66.13 ± 19.12) in the test group at 6 months (<i>p</i>= 0.000).</p> Conclusion <p> Melatonin gel as an adjunct to DFDBA enhances clinical, radiographic, and biochemical outcomes in intrabony periodontal defect therapy.</p> <p><b>Clinical Trials Registry of India</b> (CTRI/2023/07/055039)</p>

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“Clinical and radiological evaluation of periodontal intrabony defects treated with DFDBA and 1% melatonin gel and its effect on RANKL and OPG in gingival crevicularfluid – a randomized controlled trial”

  • 期刊论文

  • 发表日期：

    2025年11月8日

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  • G. Laxmi Kavya,
  • K. Anil Kumar,
  • Gautami S. Penmetsa,
  • Arun Bhupathi,
  • Sruthima NVS Gottumukkala,
  • K. S. V. Ramesh,
  • P. Mohan Kumar,
  • Pavan Kumar Samudrala

摘要

Background

This study aims to evaluate and compare the effectiveness of 1% melatonin gel combined with demineralized freeze-dried bone allograft (DFDBA) versus DFDBA alone in treating intrabony periodontal defects in Stage II & III periodontitis. Clinical and radiographic outcomes were assessed using cone-beam computed tomography (CBCT), along with analysis of gingival crevicular fluid (GCF) levels of receptor activator of nuclear factor-kappa B ligand (RANKL) and osteoprotegerin (OPG).

Methodology

A prospective, randomized, controlled, single-blinded clinical trial was conducted on 20 patients with 20 intrabony defects. The control group received DFDBA alone, while the test group received a combination of 1% melatonin gel and DFDBA. Clinical parameters Clinical Attachment Level (CAL) and Probing Pocket Depth (PPD) were evaluated at baseline, 3, and 6 months. Using cone beam computed tomography (CBCT) radiographic parameters linear bone fill and bone volume and GCF biomarkers (RANKL and OPG) were assessed at baseline and 6 months. Plaque Index (PI) and Sulcus Bleeding Index (SBI) were secondary outcomes. CAL change served as the primary outcome variable.

Results

After 6 months, the test group showed a mean CAL gain of 3.10 ± 0.87 mm and the control group 4.00 ± 1.85 mm, which was not statistically significant between the groups; however, intra-group comparison revealed a statistically significant CAL gain from baseline in both groups. Both groups showed improvements in assessed parameters, however, the test group demonstrated significantly greater bone fill (1.88 ± 0.26 mm vs. 1.16 ± 0.38 mm) and bone volume gain (22.67 ± 1.36 mm³ vs. 14.78 ± 0.5 mm³; p< 0.000). Greater reduction in PPD and gain in CAL were noted in the test group. GCF analysis revealed a significant increase in OPG (99.87 ± 15.07) and reduction in RANKL levels (66.13 ± 19.12) in the test group at 6 months (p= 0.000).

Conclusion

Melatonin gel as an adjunct to DFDBA enhances clinical, radiographic, and biochemical outcomes in intrabony periodontal defect therapy.

Clinical Trials Registry of India (CTRI/2023/07/055039)