Role of 1% alendronate gel as adjunct to mechanical therapy in the treatment of chronic periodontitis among smokers

Abstract Objective Alendronate (ALN) inhibits osteoclastic bone resorption and triggers osteostimulative properties both in vivo and in vitro, as shown by increase in matrix formation. This study aimed to explore the efficacy of 1% ALN gel as local drug delivery (LDD) in adjunct to scaling and root planing (SRP) for the treatment of chronic periodontitis among smokers. Material and Methods 75 intrabony defects were treated in 46 male smokers either with 1% ALN gel or placebo gel. ALN gel was prepared by adding ALN into carbopol-distilled water mixture. Clinical parameters [modified sulcus bleeding index, plaque index, probing depth (PD), and periodontal attachment level (PAL)] were recorded at baseline, at 2 months, and at 6 months, while radiographic parameters were recorded at baseline and at 6 months. Defect fill at baseline and at 6 months was calculated on standardized radiographs by using the image analysis software. Results Mean PD reduction and mean PAL gain were found to be greater in the ALN group than in the placebo group, both at 2 and 6 months. Furthermore, a significantly greater mean percentage of bone fill was found in the ALN group (41.05±11.40%) compared to the placebo group (2.5±0.93%). Conclusions The results of this study showed 1% ALN stimulated a significant increase in PD reduction, PAL gain, and an improved bone fill compared to placebo gel in chronic periodontitis among smokers. Thus, 1% ALN, along with SRP, is effective in the treatment of chronic periodontitis in smokers.

Introduction main aetiological factors in periodontal diseases 10 .
Additionally, extensive researches suggest that host- Additionally, studies have observed that topical application of ALN was highly effective in reducing surgery 3,4,22,24,30 .
Evidence from cross-sectional and case-control studies in various populations and an abundant number of reviews on the subject have shown that adult smokers are about two to four times more likely to have periodontitis than nonsmokers. Previous studies indicated that smokers did not respond to non-surgical periodontal therapy 2,13 . Additionally, smokers showed less probing depth reduction and attachment gain, compared to nonsmokers, for periodontal surgical treatment 11,23 .
Considering the abovementioned facts, the current gel as local drug delivery along with scaling and root planing (SRP) for the treatment of intrabony defects among smokers with chronic periodontitis.

Material and methods
Source of data Role of 1% alendronate gel as adjunct to mechanical therapy in the treatment of chronic periodontitis among smokers use of smokeless tobacco in any form; alcoholism; 46 subjects (out of 52 enrolled), who matched clinical and radiographic parameters, were recruited for double-blind clinical study ( Figure 1). Multiple sites from the same patients were also considered in case randomly (by computer generated system) assigned to either ALN or placebo group. 37 sites (2 failed) and 38 sites (4 failed) completed the study in the ALN group and placebo group, respectively. Another clinician (AS) treated subjects enrolled to either group. All pre-and posttreatment clinical parameters were recorded by an examiner (ARP) who was masked to the type of treatment received by the subjects, while another clinician (AS) provided treatment to both groups.
In the ALN group, sites were treated with SRP followed by 1% ALN gel (10 mg/ml) local drug delivery, while in the placebo group sites were treated with SRP followed by placebo gel placement. Subjects were blinded for allocation into ALN or placebo group. SRP was performed at baseline until the root surface was Gujarat, India) was dissolved in a required amount of distilled water to achieve 1% ALN concentration.
A weighed quantity of carbopol 934P (2% w/w) was taken and added to the distilled water. The mixture was gradually stirred and carbopol was allowed to soak for 2 h. 1% triethanolamine was added to neutralize the carbopol solution and to form the gel. The pH was adjusted to 6.8. Finally, the required amount of methylparaben (0.1%) and propylparaben (0.05%) were dissolved in ethanol and added to the gel. The placebo gel was prepared by the abovementioned procedure without adding the active ingredient (ALN).

Local drug delivery
The prepared ALN gel (10 mg/ml) was dispensed into the periodontal pockets with intrabony defects using a syringe with a blunt cannula. Patients were instructed not to use forceful brushing or interdental aids at the treated sites until the appointment after 2 months and to avoid chewing sticky or hard food.

Statistical analysis
Power analysis calculations were performed before the study was initiated. To achieve 90% power and detect mean differences of the clinical parameters between groups, 30 sites in each group were required.