Chronic Periodontitis
Conditions
Brief summary
The present study is designed as a single-centre, randomized, controlled clinical trial to evaluate and compare the clinical efficacy of two local drug delivery systems containing 1% ALN gel and 1.2% ATV gel in treatment of intrabony defects in patients with chronic periodontitis as an adjunct to SRP.
Detailed description
Background: Alendronate and Atorvastatin are known to inhibit osteoclastic bone resorption and were proposed to have osteostimulative properties by causing osteoblast differentiation in vivo and in vitro as shown by an increase in matrix formation. The aim of the present study is to evaluate and compare the efficacy of 1% ALN and 1.2% ATV gel as a local drug delivery system in adjunct to scaling and root planning (SRP) for the treatment of intrabony defects in patients with chronic periodontitis. Methods: A total of 90 intrabony defects were treated with either1%ALN, 1.2% ATV or placebo gel. Clinical parameters (plaque index, modified sulcus bleeding index, probing depth \[PD\], and clinical attachment level \[CAL\]) were recorded at baseline, 3, 6 and 9 months. Radiographic parameters intrabony defect depth (IBD) and defect depth reduction (DDR%) was calculated on standardized radiographs by using image analysis software at 6 and 9 months.
Interventions
DRUGSRP and Placebo gel
After SRP, placebo gel was delivered subgingivally into the pocket
DRUGSRP and Atorvastatin
After SRP, Atorvastatin gel was delivered subgingivally into the pocket
DRUGSRP and Alendronate
After SRP, Alendronate gel was delivered subgingivally into the pocket
Sponsors
Government Dental College and Research Institute, Bangalore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Systemically healthy patients with PDs ≥5mm or CALs ≥4 to 6mm and vertical bone loss ≥3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months were included
Exclusion criteria
* Patients with a known systemic disease; * known or suspected allergy to the ALN/bisphosphonate group and ATV/statin group; * on systemic ALN/bisphosphonate and therapy ATV/statin group; * with aggressive periodontitis; * who used tobacco in any form; * alcoholics; * immunocompromised patients; * and pregnant or lactating females were excluded from the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in defect depth reduction from baseline to 6 months and from baseline to 9 months | Baseline to 6 months and Baseline to 9 months | Radiographic defect depth reduction to measured at baseline, 6 and 9 months interval |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plaque index | 3,6 and 9 months | Plaque index will be measured at 3, 6 and 9 months |
| Modified sulcus bleeding index | 3,6 and 9 months] | Modified sulcus bleeding index will be measured at 3, 6 and 9 months |
| Probing pocket depth | 3,6 and 9 months] | Probing pocket depth will be measured at 3, 6 and 9 months |
| Clinical attachment level | 3,6 and 9 months] | Clinical attachment level will be measured at 3, 6 and 9 months |
Outcome results
None listed