“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”

Nov 8, 2025Clinical oral investigations

Treating deep gum bone defects with bone graft and melatonin gel and their effects on bone remodeling markers in gum fluid

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Abstract

The test group using 1% melatonin gel showed a significantly greater bone fill of 1.88 ± 0.26 mm compared to the control group with 1.16 ± 0.38 mm.

Both treatment groups displayed significant gains in clinical attachment level (CAL) from baseline after 6 months.
The control group, receiving only DFDBA, had a mean CAL gain of 4.00 ± 1.85 mm.
Gingival crevicular fluid analysis indicated a significant increase in osteoprotegerin (OPG) levels and a reduction in receptor activator of nuclear factor-kappa B ligand (RANKL) levels in the melatonin group.
The test group also experienced greater reductions in probing pocket depth (PPD) compared to the control group.
Bone volume gain was significantly higher in the test group, with a measurement of 22.67 ± 1.36 mm³ versus 14.78 ± 0.5 mm³ in the control group.

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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).

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