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Completed

NCT Number: NCT02455869

Comparison of Alendronate With Atorvastatin in Chronic Periodontitis

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.

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Key information

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

SRP and Placebo gel

Drug

After SRP, placebo gel was delivered subgingivally into the pocket

SRP and Atorvastatin

Drug

After SRP, Atorvastatin gel was delivered subgingivally into the pocket

SRP and Alendronate

Drug

After SRP, Alendronate gel was delivered subgingivally into the pocket

Primary outcomes

  1. Change in defect depth reduction from baseline to 6 months and from baseline to 9 months

    Time frame: Baseline to 6 months and Baseline to 9 months

    Radiographic defect depth reduction to measured at baseline, 6 and 9 months interval

Secondary outcomes

  1. Plaque index

    Time frame: 3,6 and 9 months

    Plaque index will be measured at 3, 6 and 9 months

  2. Modified sulcus bleeding index

    Time frame: 3,6 and 9 months]

    Modified sulcus bleeding index will be measured at 3, 6 and 9 months

  3. Probing pocket depth

    Time frame: 3,6 and 9 months]

    Probing pocket depth will be measured at 3, 6 and 9 months

  4. Clinical attachment level

    Time frame: 3,6 and 9 months]

    Clinical attachment level will be measured at 3, 6 and 9 months

Sponsors and collaborators

Lead sponsor

Government Dental College and Research Institute, Bangalore

Other

Registry information

Official study title

Comparative Evaluation of Subgingivally Delivered 1% Alendronate Versus 1.2% Atorvastatin Gel in Treatment of Chronic Periodontitis: a Randomized Placebo Controlled Clinical Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 28, 2015
Registry last updated
May 28, 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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