Clinical trial NCT02386033: Atorvastatin in the Treatment of Mandibular Degree II Furcation Defects
Official title: Clinical Efficacy of Subgingivally Delivered Atorvastatin in the Treatment of Mandibular Degree II Furcation Defects: A Randomized Controlled Clinical Trial .
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Periodontitis
Lead sponsor: Government Dental College and Research Institute, Bangalore
Sponsor class: OTHER
First posted: 2015-03-11
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: ABSTARCT Background: Atorvastatin is an inhibitor of 3-hydroxy-2-methyl-glutaryl coenzyme A reductase. Lately, it has shown to have anti-inflammatory and bone stimulatory effects. The aim of the current study is to explore the effectiveness of 1.2% atorvastatin (ATV) as an adjunct to scaling and root planning (SRP) in the treatment of mandibular degree II furcation defects.

Method: A total of sixty subjects were randomly assigned to two treatment groups. 1. SRP plus placebo gel 2. SRP plus 1.2% ATV gel. Clinical parameters like probing depth (PD), relative vertical clinical attachment level (RVCAL) , relative horizontal clinical attachment level (RHCAL), modified sulcus bleeding index (mSBI) and site specific plaque index were recorded at baseline and then at 3, 6 and 9 months. The radiological assessment of bone defect fill was done at 6 and 9 months, using a computer-aided software.

Detailed description: Two groups were made. One was delivered with ATV after SRP, the other was delivered with placebo gel after SRP.

Eligibility criteria: Inclusion Criteria:

* lower first molars demonstrating a probing pocket depth of 5 mm and horizontal probing depth of 3 mm following phase 1 therapy, with furcation defects (degree II) present bucally in asymptomatic, vital lower first molars, with a furcation radiolucency on a periapical radiograph of the molars.

Exclusion Criteria:

* patients with systemic diseases like cardiovascular disease
* diabetes or HIV infection or on medications like corticosteroids which may impede the healing in periodontal tissues.
* pregnant/lactating females
* tobacco users
* alcoholics
* patients with unsatisfactory oral hygiene (plaque index greater than 1.5)
* teeth having gingival recession, caries involving pulp, intrabony defect present interproximally, grade 2/3 mobility
* Furthermore, patients allergic to ATV or other statins or those taking ATV/other statins systemically were excluded.

Primary outcomes:
measure: amount of bone fill
timeFrame: baseline to 9 months
Secondary outcomes:
measure: change in Relative vertical clinical attachment level
timeFrame: baseline to 9 months
measure: change in RHCAL (relative horizontal clinical attachment level)
timeFrame: baseline to 9 months
measure: change in probing depth
timeFrame: baseline to 9 months
measure: change in site specific plaque index
timeFrame: baseline to 9 months
measure: change in modified sulcus bleeding index
timeFrame: baseline to 9 months
Other outcomes:
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