Comparative evaluation of the clinical and radiographic efficacy of 0.05% Zoledronate gel as local drug delivery system in treating intrabony defects in stage III grade B periodontitis patients with and without type-2 diabetes mellitus - A randomized split-mouth clinical trial
Abstract
BACKGROUND
This 6-month randomized split-mouth and placebo-controlled clinical trial aimed to evaluate the clinical and radiographic efficacy of adjunctive use of 0.05% ZLN gel as local drug delivery (LDD) to scaling and root planning (SRP) in stage III, grade B periodontitis patients with and without controlled type-2 diabetes mellitus (DM).
METHODS
120 infrabony sites were divided into two groups; GROUP-1 (non-diabetic periodontitis) and GROUP-2 (periodontitis +DM). 60 sites in each group were randomized to receive treatment with SRP+placebo gel (control) or SRP+0.05% ZLN gel (test). Plaque index (PI), modified sulcus bleeding index (mSBI), pocket probing depth (PPD) and relative attachment levels (RAL) were assessed at baseline, 3 and 6-months and digital periapical (IOPA) and cone-beam computed tomography (CBCT) imaging were used to measure the linear and percentage reduction of intrabony defect depth (DD, DDR%) after 6-months.
RESULTS
GROUP-1 showed significant reduction in PI (0.56±0.15 and 0.52±0.19 from 0.67±0.17), mSBI (0.7±0.60 and 0.47±0.57 from 0.9±0.48), PPD (4.6±0.85 and 3.43±0.63 from 6.5±1.04) and gain in RAL (7.03±0.85 and 5.93±0.69 from 8.9±1.09) in the ZLN treated sites than the placebo sites and also from GROUP-2 sites after 3 and 6 months respectively. A significant reduction in defect depth of 28.79% in GROUP-1 and 22.20% in GROUP-2 at ZLN sites was seen compared to placebo sites of both groups.
CONCLUSION
ZLN gel applied subgingivally in infrabony…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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