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Completed

NCT Number: NCT02386033

Atorvastatin in the Treatment of Mandibular Degree II Furcation Defects

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.

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Key information

Conditions

Chronic Periodontitis Chronic Disease Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

30 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Atorvastatin (ATV)

Drug

After SRP, ATV gel was delivered subgingivally into the pocket

Other names: ATV gel

Placebo Gel

Drug

After SRP, placebo gel was delivered subgingivally into the pocket

Primary outcomes

  1. amount of bone fill

    Time frame: baseline to 9 months

Secondary outcomes

  1. change in Relative vertical clinical attachment level

    Time frame: baseline to 9 months

  2. change in RHCAL (relative horizontal clinical attachment level)

    Time frame: baseline to 9 months

  3. change in probing depth

    Time frame: baseline to 9 months

  4. change in site specific plaque index

    Time frame: baseline to 9 months

  5. change in modified sulcus bleeding index

    Time frame: baseline to 9 months

Sponsors and collaborators

Lead sponsor

Government Dental College and Research Institute, Bangalore

Other

Registry information

Official study title

Clinical Efficacy of Subgingivally Delivered Atorvastatin in the Treatment of Mandibular Degree II Furcation Defects: A Randomized Controlled Clinical Trial .

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 11, 2015
Registry last updated
Mar 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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