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
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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% zoledronate (ZLN) gel as local drug delivery to scaling and root planing (SRP) in stage III, grade B periodontitis patients with and without controlled type-2 diabetes mellitus (DM).
Methods
A total of 120 infrabony sites were divided into two groups: Group-1 (non-diabetic periodontitis) and Group-2 (periodontitis + DM). A total of 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 intraoral periapical and cone-beam computed tomography 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 DD 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 pockets resulted in significant clinical improvements evident by probing depth reduction and gain in attachment levels along with radiographic evidence of more bone fill seen in non-diabetic patients compared to diabetic periodontitis patients.
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